Stem Cell Clinic

Biopharma Money on the Move: October 7-14 – BioSpace

By adminOctober 15, 2020Stem Cell Clinic

Find out which biopharma companies are raking in the cash this week, as companies from around the globe provide updates on their financing rounds and IPOs.

Evotec

The UAE dropped a load of cash to become a 5.6% stakeholder into Germanys Evotec with $236 million worth of shares purchased by their sovereign wealth fund, Mubadala Investment Company. Not one to be left out, existing investor Novo increased its stake to 11% by throwing in another $59 million, bringing Evotecs haul to about $295 million. Evotec is a drug discovery alliance and development partnership company out of Hamburg, Germany. With revenues nearly quadrupling over the last five years and a goal of 10% yearly growth in the future, its no surprise these investors want in big. Evotec plans to use the cash to reach its goals by growing, particularly in the U.S. and Europe as they ramp up global ops.

SQZ Biotech

Allied with Roche to develop new cancer cell therapies, SQZ has turned its focus to the NYSE. With a preliminary goal of $75 million for its IPO, theyve applied for listing as SQZ. While traditional cell therapies require a depletion of the immune cells to improve efficacy, SQZ claims to avoid those limitations with a proprietary technology that, as its name touts, squeezes cells through a microfluidic chip to open the cell membrane and allow the therapeutic load inside. They also tout a huge leg up in manufacturing 24-hour turnaround in comparison with a month or more for current therapies. Plus, without the pre-conditioning to weaken immune systems, SQZs technology aims to shorten hospital stays. The IPO earnings are intended to finance their groundbreaking cancer and infectious disease research.

Galecto Biotech

Just two weeks after completing a $64 million Series D round, Galecto Biotech rounds the corner and goes after the public market, hoping to raise $100 million in its IPO. If successful, the Copenhagen-based company will have totaled over $250 million in financing in just the last two years. Galectos focus is on a wide range of fibrotic disease, with its lead project, GB0139 for idiopathic pulmonary fibrosis, currently in a Phase IIb trial. The Series D and the new funding from this IPO will go toward getting the program through to approval and commercialization.

Codiak BioSciences

After filing to go public for a second time after withdrawing in 2019, Codiak finally hit the market with an $83 million IPO, falling short of its $100 million originally sought when filed in September. The bulk of the funds will be used to advance its lead program ExoSTING through a phase study in advanced or metastatic, recurrent solid tumors, support discover and preclinical R&Dand expand its engEx technology that supports its programs. Another $10 million will go into its second program, exoIL-12, through a Phase I trial in patients with cutaneous T-cell lymphoma.

EdiGene

A Series B of $67 million takes EdiGenes track record up to $100 million raised in the last two years. The Beijing-based biotech is currently leading the gene-editing wave in China with four platforms steadily advancing. The company's top candidate is a treatment for hereditary blood disease, with the next in line being a CAR-T treatment for cancer. CEO Dong Wei hopes their T cell therapeutics can help make a higher quality, lower cost option for patients and their families.

Cedilla Therapeutics

Small molecule-focused Cedilla wraps up a $57.6 million Series B round to drug the undruggable. The funding will go into preclinical work on its first two oncology candidates, which are being kept hush hush for now. They also have about five or six oncology programs running that are years away from the clinic. In addition to the Series B, Cedilla is bringing Casdin CIO and founder Eli Casdin and Boxer senior VP Dominik Naczynski onto its board of directors.

RayzeBio

Debuting with $45 million in Series A money, biotech newbie RayzeBio is ready to defeat cancer with radiopharmaceuticals. With a vision to be the first radiopharma platform in the market, RayzeBio has seven active programs and would like to see one development candidate by the second half of 2021. Radiopharmaceuticals have intrigued the biotech sphere lately, but securing a reliable supply of therapeutic radioisotopes has been a hang up. But recently the industry has devised alternate ways to generate Actinium-225, which is the radioisotope RayzeBio is working with. This new development spurred the drive to launch RayzeBio with the intent to penetrate specific tumor targets. The fledgling biotech is now rolling up its sleeves to get to work with the goal of being first.

Priothera Limited

To get more clinical data on its highly-promising therapy for high risk AML patients, Priothera closed on a $35 million USD Series A. The company's drug mocravimod should enhance the curative potential of allogeneic hematopoietic stem cell transplantation for treating AML. Allogeneic stem cell transplant is currently the only potentially curative approach for AML patients, but has a high mortality rate. This therapy appears promising for improving survival outcomes. Priothera acquired mocravimod from KYORIN Pharmaceutical.

Ori Biotech

Ori Biotech wants to speed up the innovation of cell and gene therapies via its manufacturing platform, and this weeks $30 million Series A is certainly a step in reaching that goal. Typically, a drug discovery pipeline can take an average of a decade to get from lab to patient. Oris platform closes, automates and standardizes manufacturing for cell and gene therapy developers so the company can move its treatments from pre-clinical to scale commercially. This novel automation will reduce cost of goods and the footprint. In addition to taking its platform to the market, Ori is also expecting to double its 8-head employee count in four months, and double that again by next year.

Kanaph Therapeutics

Kanaph beefs up its initial $8 million start in 2019 with a $21 million Series B in South Korea. This round of funding will go toward expediting the clinical development of Kanaphs pipelines, chiefly its TMEkine molecules platform for immuno-oncology and bi-specific Fc fusions for the treatment of retinal disease. Preclinical studies are anticipated to be completed at the end of this year or beginning of next year, and are ready for the next steps.

Rappta Therapeutics

Novo Seeds plants its stake in emerging biotech Rappta Therapeutics in a $10.5 million Series A round. Rapptas primary focus is developing first-in-class anti-cancer drugs that work by activating protein phosphatase 2A (PP2A). The PP2A enzyme is a key tumor suppressor which has historically been tricky to target with drugs. Rappta has derived a unique understanding of the protein along with propriety tools to allow therapeutic reactivation of PP2A, which offers the potential of multiple therapies with this as the platform for a new class of anti-cancer drugs. Jeroen Bakker, Principal at Novo Seeds, will join Rapptas board. Novartis Venture Fund, Advent Life Sciences and one family office also participated in the round.

Lixte Biotechnology

Previously listed on the OTCQB, Lixte is ready to take it to Nasdaq with a $9 million offering of 1.5 million shares at a price range of $5.75 to $6.75. The NY-based biotech has developed two active series LB-100 and LB-200. The current focus is on the LB-100, which targets several types of cancer and has potential for vascular and metabolic diseases. A Phase I trial has already been completed and demonstrated antitumor activity in humans. LB-100 is now in Phase Ib/II.

The rest is here:
Biopharma Money on the Move: October 7-14 - BioSpace

Bone Therapeutics’ allogeneic cell therapy product, ALLOB, shows 90% fusion rate at 24 months in Phase IIa study in lumbar spinal fusion -…

By adminOctober 15, 2020Stem Cell Clinic

Gosselies, Belgium, 14 October 2020, 7am CEST BONE THERAPEUTICS(Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces positive 24-month follow-up results for the Phase IIa study with the allogeneic cell therapy product, ALLOB, in patients undergoing lumbar spinal fusion procedures.

The 24-month data show a high percentage of successful lumbar vertebrae fusion of 90%. Patients also continue to experience important clinical improvements in function and pain, from as early as six months after treatment, up to the 24-month follow-up period.

Degenerative spine disorders have a major impact on the quality of life of patients. These impacts include decreases in the stability of the spine and pain in motion,said Dr. Alphonse Lubansu, M.D., Head of the Spinal Clinic, Erasme University Hospital, Universit libre de Bruxelles. The 24 month follow-up data of this Phase IIa clinical trial have demonstrated that patients treated with ALLOB in spinal fusion procedure show a high incidence in fusion, and benefit from a sustained, clinically meaningful improvement in function and pain throughout the 24 months following treatment together with a good safety profile. These results show that ALLOB in combination with the standard spine fusion surgery could be a promising treatment option to address the currently unmet needs of these patients.

This positive data forlumbar spinal fusion complementsthe strong Phase I/IIa results from ALLOB in patients with delayed union fractures,said Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics. These studies provide promising clinical evidence for the potential ofBone Therapeuticsunique allogeneic cell therapy platform to address high unmet medical needs in orthopaedics and bone related disorders. We will now hold discussions with global regulators and our partners to explore a variety of options for the next stages of clinical development for ALLOB in different orthopedic indications, while pursuing the phase IIb study of ALLOB in difficult tibial fractures.In addition, theclinical results provide further evidence for the expansion of ALLOB and our platform of differentiated MSCs to other indications.

The multi-center, open-label proof-of-concept Phase IIa study was designed to evaluate the safety and efficacy of ALLOB administered, procedure in which an interbody cage with bioceramic granules mixed with ALLOB is implanted into the spine to achieve fusion of the lumbar vertebrae. The main endpoints of the 24-month follow-up analysis included safety and radiological assessments to evaluate vertebrae fusion (continuous bone bridges) and clinical assessments to evaluate improvement in patients functional disability as well as reduction in back and leg pain. The study evaluated 30 patients treated with ALLOB, 29 patients attended the 24-month visit.

Radiological data was collected from CT-scans at 24 months and assessed by three external readers. It showed a successful fusion of the lumbar vertebrae in 27 out of 30 patients (90%). In addition, the remaining 3 patients showed radiological evidence of bone formation. Treatment with ALLOB also resulted in a clear and statistically significant clinical improvement in function and reduction in pain over the 24-month follow-up period. Functional disability improved from the pre-treatment baseline to 24-month by a mean score of 60% (p<0.001) on the Oswestry Disability Index(1). Back and leg pain were strongly reduced by 57 to 62% (p<0.001) and 68 to 70% (p<0.001) respectively compared to pre-treatment baseline. Treatment with ALLOB was generally well-tolerated by the patients, consistent with previous reported results.

(1)The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to measure a patients permanent functional disability. This validated questionnaire was first published by Jeremy Fairbank et al. in Physiotherapy in 1980. ODI score of 0%-20%: minimal disability; 21%-40%: moderate disability; 41%-60%: severe disability; 61%-80%: crippled; 81%-100%: bed bound.

About Spinal Fusion

Due to ageing populations and sedentary lifestyles, the number of people suffering from degenerative spine disorders continues to increase. Today, spinal fusion procedures are performed to relieve pain and improve patient daily functioning in a broad spectrum of degenerative spine disorders. Spinal fusion consists of bridging two or more vertebrae with the use of a cage and graft material, traditionally autologous bone graft or demineralised bone matrix placed into the intervertebral space for fusing an unstable portion of the spine and immobilizing a painful intervertebral motion segment. Over 1,000,000 spinal fusion procedures are performed annually in the US and EU, of which half at lumbar level and the market is growing at a rate of 5% per year. Although spinal fusion surgery is routine, non-fusion, slow progression to fusion and failure to eliminate pain are still frequent with up to 35% of patients not being satisfied with their surgery.

About ALLOB

ALLOB is the Companys off-the-shelf allogeneic cell therapy platform consisting of human allogeneic bone-forming cells derived from cultured bone marrow mesenchymal stem cells (MSC) from healthy adult donors, offering numerous advantages in product quality, injectable quantity, production, logistics and cost as compared to an autologous approach. To address critical factors for the development and commercialisation of cell therapy products, Bone Therapeutics has established a proprietary, optimised production process that improves consistency, scalability, cost effectiveness and ease of use of ALLOB. This optimized production process significantly increases the production yield, generating 100,000 of doses of ALLOB per bone marrow donation. Additionally, the final ALLOB product will be cryopreserved, enabling easy shipment and the capability to be stored in a frozen form at the hospital level. The process will therefore substantially reduce overall production costs, simplify supply chain logistics, improve patient accessibility and facilitate global commercialisation. The Company will implement the optimized production process for all future clinical trials with ALLOB.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company is ready to start the phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available atwww.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SA Miguel Forte, MD, PhD, Chief Executive Officer Jean-Luc Vandebroek, Chief Financial Officer Tel: +32 (0)71 12 10 00 investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries: Bepublic Catherine Haquenne Tel: +32 (0)497 75 63 56 catherine@bepublic.be

International Media Enquiries: Image Box Communications Neil Hunter / Michelle Boxall Tel: +44 (0)20 8943 4685 neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries: NewCap Investor Relations & Financial Communications Pierre Laurent, Louis-Victor Delouvrier and Arthur Rouill Tel: +33 (0)1 44 71 94 94 bone@newcap.eu

For US Media and Investor Enquiries: LHA Investor Relations Yvonne Briggs Tel: +1 310 691 7100 ybriggs@lhai.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

The Infodemic: Was Regeneron COVID-19 Treatment Developed Using Stem Cells and Fetal Tissue? – Voice of America

By adminOctober 15, 2020Embryonic Stem Cells

Fake news about the coronavirus can do real harm. Polygraph.info is spotlighting fact-checks from other reliable sources here.

Claim:The development of REGN-COV2, the experimental anti-viral antibody cocktail given to U.S. President Donald Trump to treat COVID-19, involved the use of human fetal tissues and embryonic stem cells.

Verdict:Mixture

Read the full story at:Snopes

Circulating on social media:An article claiming to give ultimate proof that the novel coronavirus pandemic was planned to create a new world order.

Verdict:False

Read the full story at:Reuters

More Testing, Faster Testing More types of tests for the coronavirus are becoming available, but how do we know which to use when? -- American Scientist, October 12

Watch: Understanding dexamethasone, the steroid used to treat Trumps Covid-19 It is inexpensive and widely prescribed. But side effects of dexamethasone can be quite serious. -- Stat, October 12

Read this article:
The Infodemic: Was Regeneron COVID-19 Treatment Developed Using Stem Cells and Fetal Tissue? - Voice of America

COVID-19 Impact on Global Human Embryonic Stem Cells Market 2020 Industry Overview, Demand and Insights Analysis Report by 2026 ESI BIO, Thermo…

By adminOctober 15, 2020Embryonic Stem Cells

New York, United States TheGlobal Human Embryonic Stem Cells Market Report 2020-2026(Forecast Period) offers an in-depth study of market growth factors, future evaluation, country-level analysis, market distribution, and competitive landscape study of significant industry players. Every segment of the global Human Embryonic Stem Cells market is extensively assessed in the research report. The segment analysis offers critical opportunities available in theglobal Human Embryonic Stem Cells marketthrough leading segments. The regional study of the global Human Embryonic Stem Cells market helps readers to attain a thorough understanding of the developments of the different geographic markets in recent years and also going forth. In addition, the report provides a comprehensive overview of the vital dynamics of the global Human Embryonic Stem Cells market, including market influence and market effect factors, drivers, threats, constraints, trends, and prospects. The research study also contains other forms of analysis, such as qualitative and quantitative.

This Report covers the manufacturers data, including: shipment, price, revenue, gross profit, interview record, business distribution etc., these data help the consumer know about the competitors better. This report also covers all the regions and countries of the world, which shows a regional development status, including market size, volume and value, as well as price data.

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Industrial Analysis of Human Embryonic Stem Cells Market:

ESI BIO, Thermo Fisher, BioTime, MilliporeSigma, BD Biosciences, Astellas Institute of Regenerative Medicine, Asterias Biotherapeutics, Cell Cure Neurosciences, PerkinElmer, Takara Bio, Cellular Dynamics International, Reliance Life Sciences, Research & Diagnostics Systems, SABiosciences, STEMCELL Technologies, Stemina Biomarker Discovery, Takara Bio, TATAA Biocenter, UK Stem Cell Bank, ViaCyte, Vitrolife

Attributes such as new development in Human Embryonic Stem Cells market, Total Revenue, sales, annual production, government norm, and trade barriers in some countries are also mentioned in detail in the report. Human Embryonic Stem Cells Report discusses about recent product innovations and gives an overview of potential regional market shares.

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This study specially analyses the impact of Covid-19 outbreak on the Human Embryonic Stem Cells, covering the supply chain analysis, impact assessment to the market size growth rate in several scenarios, and the measures to be undertaken by companies in response to the COVID-19 epidemic.

Segmentation by Type: Totipotent Stem Cells, Pluripotent Stem Cells, Unipotent Stem Cells

Segmentation by Application: Research, Clinical Trials

Impact of COVID-19:

Human Embryonic Stem Cells Market report analyses the impact of Coronavirus (COVID-19) on the industry. Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost 180+ countries around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the Human Embryonic Stem Cells market in 2020.

The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor events restricted; emergency declared in many countries; massive slowing of the supply chain; stock market unpredictability; falling business assurance, growing panic among the population, and uncertainty about future. COVID-19 can affect the global economy in 3 main ways: by directly affecting production and demand, by creating supply chain and market disturbance, and by its financial impact on firms and financial markets.

Reason to purchase Human Embryonic Stem Cells market report:

The report offers market sizing and growth prospects of the Human Embryonic Stem Cells market for the forecast period 20202026. The report provides the capability to measure Human Embryonic Stem Cells market to aim the growth of upcoming products, pricing strategies, predictions about new launching products. Provides comprehensive insights on the latest industry trends, market forecast, and growth drivers in the Human Embryonic Stem Cells market. The report contains a detailed analysis of market growth factors, market drivers, challenges, and investment opportunities. The report delivers a complete summary of market segments, sub-segments and the regional outlook of the market. Offers an exhaustive summary of the vendor landscape, competitive analysis, and key market strategies to gain a competitive advantage in the Human Embryonic Stem Cells market. Deliver region wise & country-wise detailed & accurate information of market.

The report forecast global Human Embryonic Stem Cells market to grow to reach xx Million USD in 2019 with a CAGR of xx% during the period 2020-2026 due to coronavirus situation. The report offers detailed coverage of industry and main market trends with impact of coronavirus. The market research includes historical and forecast market data, demand, application details, price trends, and company shares of the leading by geography. The report splits the market size, by volume and value, on the basis of application, type and geography.

In this report, we analyze global market from 5 major geographies:Asia-Pacific [China, Southeast Asia, India, Japan, Korea, Western Asia], Europe [Germany, UK, France, Italy, Russia, Spain, Netherlands, Turkey, Switzerland], North America [United States, Canada, Mexico], Middle East & Africa [GCC, North Africa, South Africa], South America[Brazil, Argentina, Columbia, Chile, Peru].

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Table of Content:

Market Overview:This is the first section of the report that includes an overview of the scope of products offered in the global Human Embryonic Stem Cells market, segments by product and application, and market size.

Market Competition by Player:Here, the report shows how the competition in the global Human Embryonic Stem Cells market is growing or decreasing based on deep analysis of market concentrate rate, competitive situations and trends, expansions, merger and acquisition deals, and other subjects. It also shows how different companies are progressing in the global market in terms of revenue, production, sales, and market share.

Company Profiles and Sales Data:This part of the report is very important as it gives statistical as well as other types of analysis of leading manufacturers in the global Human Embryonic Stem Cells market. It assesses each and every player studied in the report on the basis of main business, gross margin, revenue, sales, price, competitors, manufacturing base, product specification, product application, and product category.

Market Status and Outlook by Region:The report studies the status and outlook of different regional markets such as Europe, North America, the MEA, Asia Pacific, and South America. All of the regional markets researched about in the report are examined based on price, gross margin, revenue, production, and sales. Here, the size and CAGR of the regional markets are also provided.

Market by Product:This section carefully analyzes all product segments of the global Human Embryonic Stem Cells market.

Market by Application:Here, various application segments of the global Human Embryonic Stem Cells market are taken into account for research study.

Market Forecast:It starts with revenue forecast and then continues with sales, sales growth rate, and revenue growth rate forecasts of the global Human Embryonic Stem Cells market. The forecasts are also provided taking into consideration product, application, and regional segments of the global market.

Upstream Raw Materials:This section includes industrial chain analysis, manufacturing cost structure analysis, and key raw materials analysis of the global Human Embryonic Stem Cells market.

Marketing Strategy Analysis, Distributors:Here, the research study digs deep into behavior and other factors of downstream customers, distributors, development trends of marketing channels, and marketing channels such as indirect marketing and direct marketing.

Research Findings and Conclusion:This section is solely dedicated to the conclusion and findings of the research study on the global Human Embryonic Stem Cells market.

Appendix:This is the last section of the report that focuses on data sources, viz. primary and secondary sources, market breakdown and data triangulation, market size estimation, research programs and design, research approach and methodology, and the publishers disclaimer.

Human Embryonic Stem Cells Market 2020, Human Embryonic Stem Cells Market Analysis, Human Embryonic Stem Cells Market Forecast, Human Embryonic Stem Cells Market Outlook, Human Embryonic Stem Cells Market Trends, Human Embryonic Stem Cells Market Research, Human Embryonic Stem Cells Market Sales & Price, Human Embryonic Stem Cells Market Size & Share, Human Embryonic Stem Cells Market CAGR Competitive Landscape, Human Embryonic Stem Cells Market Growth

Note In order to provide a more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19. (*If you have any special requirements, please let us know and we will offer you the report as you want.)

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Yes on 14 | Mailbox | independentnews.com – Livermore Independent

By adminOctober 15, 2020Embryonic Stem Cells

I am a clinical immunologist that happens to also be a stem cell scientist with 45 years of experience. The first CD34 bone marrow transplantation in 1978 was done at Roswell Park using FACS flow cytometry. We watch GvHD take hold to many leukemia patients to these brave patients trying to save their life with no way to treat them, until now with MSC (mesenchymal stem cells).

I watched many patients give their lives to science research for a chance of cures, which we had successes 40 years forward, if you get CML, CLL you have 98% of treatment or cure. CAR T and other treatments etc.

My concerns (are that) the media is presenting a perspective in vacuum of the stem cell world in California. Prop 71 put California in play and pushed embryonic research. The people of California need to protect their investment of $3.3 billion, or the industry leadership will be lost along with the clinical trials supported by CIRM. Please do not underestimate the RPE for blindness. #1 unmet medical need when the Japanese pharma Astellas bought Ocata in 2015 and put it on the shelf setting back embryonic research.

Lets look at say, Mesoblast, a Australian stem cell company and the leader in field with four studies. (They) had a setback recently of their BLA of SR aGvHD for kids under 12 years old (which is a death sentence) using MSC stem cells (approved for treatment in Japan for two years now) on the first stem cells for regenerative medicine to be approved the FDA, on Sept. 30, 2020. Mesoblast has 330 double blind studies for Covid19 treatment.

We will know before Christmas if FDA will approve these cells. MSC will be better than vaccinations, with super antigens stimulating the immune memory cells being develop by many companies and Federal government.

Two points: federal funding for embryonic research is not very well supported, and you cannot put a price tag on the patients who are willing to put their life on the line for hope and a chance.

Stay in the game California - do not be shortsighted.

Here is the original post:
Yes on 14 | Mailbox | independentnews.com - Livermore Independent

I’ve Spent Decades Studying How People Build Their Families. Here’s What I’ve Learned Matters Most – TIME

By adminOctober 15, 2020Embryonic Stem Cells

For decades people have raised concerns about families that vary from the structure of one mother, one father and biological children and assumed that the children would be harmed in some way as a result. The greater the difference from the traditional family, the greater the perceived risk of psychological harm to the child, the conventional wisdom goes.

This is wrong. I can say this definitively because Ive been studying different family forms for more than 40 years, analyzing families with lesbian mothers, gay fathers, transgender parents, single mothers by choice, and families created by egg donation, sperm donation, embryo donation and surrogacy, and all my research points to one conclusion: What matters most for children is not the make-up of a family. What matters most is the quality of relationships within it, the support of their wider community and the attitudes of the society in which they live.

My first study, which I began in 1976, addressed the questions raised in custody disputes about the effect on children of growing up with lesbian mothers: Were lesbian mothers less capable as parents? Were their children more likely to experience emotional and behavioral problems? The research found no evidence of raised levels of psychological problems in children who, following their parents divorce, were raised by lesbian mothers. Later studies went on to examine families in which lesbian mothers had their children with sperm donation, which became more common in the 80s and 90s, again finding no differences between these children and children born through sperm donation to heterosexual couples. Today, there is a large body of research confirming the findings of these early investigations.

Questions were also raised about children born to heterosexual couples through assisted reproductive technologies, especially those conceived using donated eggs, sperm or embryos, following the birth of the first baby through in vitro fertilization in 1978. If the child lacked a genetic and/or gestational link to one or both parents, would that interfere with the relationship between them? And would keeping their conception secret, which was common at the time, have a negative impact on the child? Some people even claimed children born via IVF wouldnt have a soul. With surrogacy, for both heterosexual and LBGTQ couples, it was assumed that children would be distressed by the knowledge that they had been created for the sole purpose of being given away to other parents. More recently, concerns have been raised about families with gay fathers, because men are thought to be less naturally suited to parenting than women, about single mothers by choice, whose children usually dont know the identity of their biological fathers, and about children who experience a parents gender transition, because they may find it confusing and difficult to accept.

The longitudinal research that I and my colleagues conducted at the University of Cambridge Centre for Family Research has shown that children born to heterosexual couples through assisted reproduction show high levels of psychological well-being, and that children benefit from being told about their origins at an early age. Our more recent studies on families with gay fathers who adopt or turn to surrogacy, families created by single mothers by choice, and families with transgender parents have produced similar findings. Contrary to the expectation that they would experience problems, we found that these families are just as likely to flourish as traditional families, and sometimes more so.

Still, the existence of these findings has not prevented these families from facing stigma and discrimination. This term the Supreme Court will hear the case of Fulton v. City of Philadelphia, in which Catholic Social Services, a faith-based foster care agency, claims that it should be exempt from the citys law banning discrimination against same-sex couples who wish to be foster parents. The Courts ruling on whether exemptions from non-discrimination legislation on religious grounds are permitted has enormous consequences for adoption and fostering. In 2016, more than 27,000 same-sex couples were raising adopted or fostered children in the United States. These are often children who have experienced trauma, such as neglect or abuse, in their early years, and who, research shows, benefit from being raised in loving gay and lesbian families. A ruling in favor of the Catholic agency could deny future children this opportunity.

The ways in which we build our families will continue to evolve. A 2017 GLAAD survey showed 20% of 18- to 34-year-olds identified as LGBTQ, compared to 7% of 52- to 71-year-olds, meaning we should expect more families that do not involve two straight parents and their biological children in the future. In 2018, BioNews, a weekly online bulletin on whats new in genetics and reproduction, reported on a demographic study predicting that 3% of the worlds population around 400 million people may result from assisted reproductive technologies by 2100, a figure that includes those conceived through assisted reproduction and their descendants. And in their June 2020 article, Reproduction Reimagined, Eli Adashi and Glenn Cohen claimed that the use of gametes derived from human embryonic stem cells to create children who are genetically related to both partners in same-sex couples is just a matter of time.

Just because people become parents in nontraditional ways does not make them less capable ones or love their children less. In fact, my research suggests the opposite. The sooner we accept this, the better off these kids we claim to be so concerned about will be. Because theres another finding that stands out loud and clear from our research: although the make-up of families does not affect the well-being of these kids, intolerance of their family does.

The untapped market of cord blood banking – The Malaysian Reserve

By adminOctober 15, 2020Stem Cell Medicine

The untapped market of cord blood banking Thursday, October 15th, 2020 at , Life & Art

Stem cell therapy could be one of the complementary treatments to alleviate sufferings in Covid-19 patients

By AZALEA AZUAR

Wong says his team aims to do their part in raising awareness about the importance of stem cell banking in Malaysia

ACCORDING to a recent study and clinical trial in China, mesenchymal stem cell (MSC) therapy has been shown to alleviate pneumonia and acute respiratory syndrome (ARDS) symptoms through their immunomodulatory activities in Covid-19 patients.

Although more research studies and clinical trial results are needed to demonstrate the use of stem cells in providing relief to Covid-19 patients, the findings have been rather encouraging.

Patients treated with MSCs have somehow regained lung functions and have restored levels of cytokines and trophic factors.

In short, stem cell therapy could be one of the complementary treatments to alleviate sufferings in Covid-19 patients.

While stem cell therapy has been used in different health procedures for various ailments, the rise in the number of Covid-19 patients worldwide is an indication that the potential for companies that promote such treatment is certainly huge.

However, the stem cell banking industry in Malaysia has not been exploited yet as in-depth information about cord blood banking applications and clinical trials is still not widely available to the public.

StemLife Bhd CEO Raymond Wong said there are advertisements about stem cell therapies and supplements that are unproven, which left the public somewhat misinformed.

A study conducted by nurses in Malaysia discovered that 92% of respondents only had moderate knowledge of the technology. In another study, 80% of respondents said their healthcare providers were unable to provide sufficient information regarding stem cells, while 94% wanted their healthcare provider to share the information, he told The Malaysian Reserve in an interview.

Wong said his team aims to do their part in raising awareness about the importance of stem cell banking in Malaysia.

It is a form of insurance for families. Our team sees it as one of the best healthcare investment options because the list of cell-based therapy applications is growing throughout the year and there have been many recent research and medical advances in regard to stem cell therapy, he said.

Wong said banking stem cells would be a long-term investment that families and individuals could live healthier, longer and happier.

At the same time, he said the technology also serves as a sustainable medical solution that is readily available.

For the uninitiated, a stem cell has the unique ability to develop into specialised cell types in the body. In the future, they may be used to replace cells and tissues that have been damaged or lost due to different diseases.

By 2025, the world stem cell market is projected to reach more than US$12.5 billion (RM51.88 billion).

The US is expected to maintain a 9.7% growth momentum, while Germany will bring some US$294.1 million to Europe in the next five to six years.

In Asia, Japans stem cell industry will reach a market size of US$899.5 million and it has the potential to grow at 8.1% over the next couple of years.

Wong said cord blood banking is another service under the stem cell market, where the blood from the umbilical cord is extracted during birth to treat more than 80 genetic diseases since it contains a rich source of stem cells.

One small amount of cord blood is collected and can be stored for future use.

By 2023, the Asia-Pacific region is expected to dominate the global cord banking services market in terms of growth rate.

The region is also expected to show a huge growth potential due to the increasing awareness of stem cell banking, as well as vast improvements in healthcare reforms in countries like Indonesia, India, Malaysia and China, although it currently has a minimal share in the global market.

Such a bright outlook in the region also grants better opportunities for companies that offer such solution to grow in a huge and untapped regional market which is currently trailing behind regions like North America and Europe.

The Younger, The Better

The procedure of collecting cord blood and umbilical cord does not harm the baby or the mother

Wong said previously, bone marrow and umbilical cord were popular sources to extract stem cells, but with the advancement in stem cell therapy, researchers have successfully extracted stem cells from other sources too.

The younger the stem cells, the better the regenerative properties. The youngest source of stem cells that we can extract from the human body is from the umbilical cord.

On top of that, the umbilical cord is also the richest source of stem cells with over 20 million cells per cu cm, Wong said.

He said stem cell extraction from the bone marrow is seen more as an invasive procedure, which always carries the risk of complications as it could also result in permanent damage to the site of extraction.

On the contrary, the procedure of collecting cord blood and umbilical cord does not harm the baby or the mother.

In fact, our standard operation of procedure places the highest priority on the safety of the mother and the baby before any collection can be done, he said.

Wong said studies have also proven that transplantation of stem cells from umbilical cord carries lower risk of developing graft versus host complication, as the stem cells in the umbilical cord arent fully developed.

Therefore, he said, the human leukocyte antigen matching of stem cells to the patient is less stringent compared to stem cells from other sources.

Specific Stem Cells

Successes in the clinical application of stem cells serve as graphic illustrations of how it can be translated into useful therapies

Just as there are many ways to extract stem cells, there are also different types of stem cells used to treat different diseases.

One of them is blood-forming cells which can develop into all types of blood cells.

This unique property allows the blood-forming stem cells to be successfully used to treat various blood disorders and blood malignancies like leukaemia and thalassemia, Wong said.

However, he said stem cells are not only limited for blood-related illness treatment as they can also treat other disorders, such as immunodeficiency disorders and certain types of metabolic disorders.

To date, there are about 80 diseases that are recognised by Malaysias Ministry of Health (MoH) as standard care of treatment using blood-forming stem cell therapy.

Moreover, the discovery of tissue- forming stem cells has led to growing interest in the use of these cells as therapeutics, Wong said.

He added that researches about stem cells are now venturing into preclinical and clinical studies to resolve injuries by enhancing endogenous repair programmes.

He said there are also tissue-forming cells which have been widely tested in clinical trials of cardiovascular, neurological and immunological diseases with encouraging results.

Pioneering studies that led to successful culturing of human epithelial stem cells opened the door for subsequent clinical applications of epithelial stem cells in regenerative medicine, Wong added.

Such treatments were first applied during the 1980s to treat patients who suffered from burns. Now, it saves the lives of those who have been severely burnt.

Furthermore, developing applications to generate corneal cells for treating certain forms of blindness has garnered the focus of clinical researchers.

More recently, cases of eye damage have been successfully treated by transplanting the corneal epithelial sheets cultured from epithelial stem cells.

Wong added that successes in the clinical application of stem cells serve as graphic illustrations of how exciting advances in the laboratory can be translated into useful therapies.

It encourages the development of other stem cell applications in the regenerative medicine field.

Things to Consider

One can choose to go to either the public or cord blood banking facilities. The public cord blood banking facilities are within the purview of the National Blood Bank which is parked under the MoH, where any mothers can make their donations.

The public also have a choice to do non-directed donations, directed donations (among at-risk families) and directed donations (for low-risk families).

Wong said while private banking is a good choice, many families are concerned that they have to pay a high price for such peace of mind.

In terms of affordability, the costs at private cord blood banks are not as high as some might think. For example, at StemLife, the cost to store cord blood roughly translates to about only 80 sen a day.

In comparison, that is more affordable than your daily morning coffee or tea at a coffee shop or kopitiam, he said.

StemLife also encourages parents to consult their healthcare providers on the benefits of storing in private banks, especially if a family member has a high risk of developing or have been diagnosed with diseases that are treatable with stem cell therapy.

This would ensure the sufficiency of stem cells for future treatments.

Secondly, with the advancement of clinical research in regenerative medicine, its worth considering its future usage.

For example, umbilical cord blood-derived MSCs have proven to be beneficial, exhibiting therapeutic effects in Covid-19 patients with cytokine storm and ARDS, Wong said.

Going Digital

Last year, more than 60,000 mothers registered with StemLife. However, due to the Covid-19 pandemic, StemLifes business suffered just like any other private healthcare providers in the first half of the year.

This is mainly due to limited outreach to the expectant parents from our customer-facing channels during the pandemic and the safety measures taken by the government, Wong said.

Nevertheless, the number of donors has been picking up steadily under the Recovery Movement Control Order, and StemLife is now keeping a more positive outlook.

Wong said digital engagements would help the company further interact with other potential donors.

The most significant changes will be in the way we introduce our services how we engage with our customers and our utilisation of customer data. These changes will lead to much greater levels of personalisation, Wong said.

Currently, StemLife is looking at adopting the digital-first advice approach among their team members, by engaging customers via video call from the comfort of their homes.

Secondly, we are looking to create a seamless customer purchase process through digitalisation. Thirdly, we aim to keep track of our customers data, while maintaining a high level of privacy to personalise customer experience, Wong commented.

They aim to monitor the three phases of motherhood which is conceiving, expecting and parenthood.

This is to ensure the mothers receive the help they need as they go through the many phases of their journey with their babies.

Secondly, we will be embarking on a digital rebranding exercise to strengthen our competitive position and energising our teams internally. In addition, we will also be ensuring that our remote workplace set-ups are smooth by using collaboration tools embedding these solutions into our operating model and roadmaps, Wong said.

StemLife is also planning to introduce genomic screening tests that can help detect disease risks of newborns through strategic partnerships.

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The untapped market of cord blood banking - The Malaysian Reserve

Singapore invents digitized optimization of culture conditions for cell therapy – BSA bureau

By adminOctober 15, 2020Stem Cell Medicine

Collaboration by researchers in Singapore and Australia leads to first-of-its-kind computational biology algorithm that could enable more effective cellular therapies against major diseases.

Cellular therapy is a powerful strategy to produce patient-specific, personalized cells to treat many diseases, including heart disease and neurological disorders. But a major challenge for cell therapy applications is keeping cells alive and well in the lab.

Researchers at Duke-NUS Medical School, Singapore, and Monash University, Australia, have devised an algorithm that can predict what molecules are needed to keep cells healthy in laboratory cultures. They developed a computational approach called EpiMogrify, that can predict the molecules needed to signal stem cells to change into specific tissue cells, which can help accelerate treatments that require growing patient cells in the lab.

Computational biology is rapidly becoming a key enabler in cell therapy, providing a way to short-circuit otherwise expensive and time-consuming discovery approaches with cleverly designed algorithms, said Assistant Professor Owen Rackham, a computational biologist at Duke-NUS, and a senior and corresponding author of the study, published today in the journal Cell Systems.

In the laboratory, cells are often grown and maintained in cell cultures, formed of a substance, called a medium, which contains nutrients and other molecules. It has been an ongoing challenge to identify the necessary molecules to maintain high-quality cells in culture, as well as finding molecules that can induce stem cells to convert to other cell types.

The research team developed a computer model called EpiMogrify that successfully identified molecules to add to cell culture media to maintain healthy nerve cells, called astrocytes, and heart cells, called cardiomyocytes. They also used their model to successfully predict molecules that trigger stem cells to turn into astrocytes and cardiomyocytes.

Research at Duke-NUS is paving the road for cell therapies and regenerative medicine to enter the clinic in Singapore and worldwide; this study leverages our expertise in computational and systems biology to facilitate the good manufacturing practice (GMP) production of high-quality cells for these much needed therapeutic applications, said Associate Professor Enrico Petretto, who leads the Systems Genetics group at Duke-NUS, and is a senior and corresponding author of the study.

The researchers added existing information into their model about genes tagged with epigenetic markers whose presence indicates that a gene is important for cell identity. The model then determines which of these genes actually code for proteins necessary for a cells identity.

Additionally, the model incorporates data about proteins that bind to cell receptors to influencetheir activities. Together, this information is used by the computer model to predict specific proteins that will influence different cells identities.

This approach facilitates the identification of the optimum cell culture conditions for converting cells and also for growing the high-quality cells required for cell therapy applications, said ARC Future Fellow Professor Jose Polo, from Monash Universitys Biomedicine Discovery Institute and the Australian Research Medicine Institute, who is also a senior and corresponding author of the study.

The team compared cultures using protein molecules predicted by EpiMogrify to a type of commonly used cell culture that uses a large amount of unknown or undefined complex molecules and chemicals. They found the EpiMogrify-predicted cultures worked as well or even surpassed their effectiveness.

The researchers have filed for a patent on their computational approach and the cell culture factors it predicted for maintaining and controlling cell fate. EpiMogrifys predicted molecules are available for other researchers to explore on a public database: http://epimogrify.ddnetbio.com.

The developed technology can identify cell culture conditions required to manipulate cell fate and this facilitates growing important cells in chemically-defined cultures for cell therapy applications, added Dr Uma S. Kamaraj, lead author of the study and a graduate of Duke-NUS Integrated Biology and Medicine PhD Programme.

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Singapore invents digitized optimization of culture conditions for cell therapy - BSA bureau

Pluristem Announces Clearance to Move Forward with Enrollment for Cohort II in an Investigator-Led Phase I/II Chronic Graft vs Host Disease…

By adminOctober 15, 2020Stem Cell Medicine

HAIFA, Israel, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced that it has received clearance from the safety committee of an investigator initiated Phase I/II study to move forward with patient enrollment for cohort II. The study will evaluate PLX-PAD cells in the treatment of steroid-refractory chronic graft vs. host disease (GvHD) and is led by Principal Investigator Prof. Ron Ram, Director of the Hematology Blood and Marrow Stem Cell Transplantation Unit at Tel Aviv Sourasky Medical Center, Ichilov Hospital, Israel. Prof. Ram and his research staff are responsible for the design and implementation of the study at Sourasky Medical Center.

GvHD is a severe complication in patients who have undergone an allogeneic hematopoietic cell transplantation (HCT) and is a major cause of morbidity and mortality in these patients in which the donated stem cells identify the recipient's body as foreign and attack it. The chronic form of GvHD (cGvHD) usually appears later than 100 days post-transplant.

Cohort I included 6 patients treated with 2 injections of 150 million cells, a week apart. At the 3-month follow up, interim safety results concluded that PLX-PAD cells were safe and that no treatment related side effects were reported. Efficacy results demonstrated that 4 out of the 6 patients reported improvement in symptoms that translated into a reduction in the severity of cGvHD with notable reduction in the required steroid doses for part of the patients. Based on these results, the study was approved to commence enrollment of 14 patients in cohort II to be treated with 4 injections of 150 million cells.

Prof. Ram of Ichilov Hospital commented, From our experience in having treated 6 patients in the study to date, we have so far found no negative side effects from the use of the PLX-PAD cells in the treatment of steroid-refractory cGvHD. Patients with significant GvHD skin disorders previously unresponsive to multiple types of therapy showed remarkable response. Responses were also observed for severe mouth ulcers which prevented patients from eating solid foods. This resulted in a major improvement of quality of life and tapering of steroid doses."

Pluristem is committed to contributing to the wellbeing and quality of life of our patients. cGvHD is an indication where we see a significant need to enhance the current course of treatment for this life-threatening condition among patients undergoing bone marrow transplants. The preliminary results from cohort I of this Phase I/II study, and prior preclinical data, both indicate that PLX-PAD cells may potentially treat cGvHD patients and mitigate symptoms. We are very pleased to cooperate with Prof. Ram and Sourasky Medical Center, and we place a high importance in examining PLX-PAD for this indication, stated Pluristem CEO and President, Yaky Yanay.

About cGvHD Chronic graft-versus-host disease (cGvHD) remains a common and potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation (HCT). The 2-year cumulative incidence of chronic GvHD requiring systemic treatment is 30% to 40% by National Institutes of Health criteria1. The hematopoietic stem cell transplants are used to treat bone marrow failure resulting from treatment of some blood or bone marrow cancers as well as other hematologic failures, such as aplastic anemia, which are not related to cancer. The donated cells identify the recipients body as foreign and attack it as a result. While acute GvHD usually appears in the first 100 days after a transplant, and in specific body systems, chronic GvHD can occur at any time (even several years) after a transplant, and may manifest in many parts of the body such as: skin, mouth, eyes, liver, intestines, lungs and joints. Long term immunosuppression is given to try to prevent or treat cGvHD. Since this treatment suppresses the immune system for a very long time, patients are at high risk of infections, and are prescribed multiple medications to try to address this major risk.

About Pluristem Therapeutics Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the patient enrollment for cohort II for its Phase I/II study of its PLX-PAD cells, the implication from the results of the first patient cohort in the study, the belief that GvHD is an indication that has a significant need for enhanced treatments among patients undergoing bone marrow transplants and that the preliminary results from cohort I of the study, and the prior preclinical data, indicate that PLX-PAD cells may potentially treat chronic GvHD patients and mitigate symptoms. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana Rubin Director of Investor Relations 972-74-7107194 danar@pluristem.com

_________________________________

1 Flowers ME, Martin PJ. How we treat chronic graft-versus-host disease. Blood. 2015 Jan 22;125(4):606-15. doi: 10.1182/blood-2014-08-551994. Epub 2014 Nov 14. PMID: 25398933; PMCID: PMC4304105., https://pubmed.ncbi.nlm.nih.gov/25398933/

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Prop. 14: In the COVID age, can California still afford its stem cell research program? – CALmatters

By adminOctober 15, 2020Stell Cell Research

In summary

Proposition 14 asks voters to spend nearly $8 billion to continue the stem cell research program at a time when the coronavirus pandemic has decimated the state budget.

For the second time in 16 years, California voters will decide the fate of the states multi-billion dollar stem cell research program that established the state as a worldwide leader.

How the times have changed.

In November, as the pandemic drags on, Proposition 14 asks voters to spend nearly $8 billion to continue the program during a period when the research environment has significantly evolved and coronavirus has battered the states budget.

The bond measure would approve $5.5 billion in bonds to keep the states stem cell research agency running and grants flowing to California universities and companies.

At least $1.5 billion would be earmarked for brain and central nervous system diseases like Alzheimers and Parkinsons. The overall cost of the bonds and their interest totals about $7.8 billion, according to the state legislative analyst. The state would pay about $260 million annually for 30 years, or about 1 percent of Californias annual budget.

Proposition 14 is essentially a repeat with a bigger price tag and a few tweaks of Proposition 71, which California voters approved in 2004 after then-President George W. Bush prohibited, on religious grounds, all federal funding of any stem cell research using human embryos.

The bond measure would approve $5.5 billion in bonds to keep the states stem cell research agency running and grants flowing to California universities and companies.

That groundbreaking measure authorized $3 billion in state bonds to create the states stem cell research agency, the California Institute for Regenerative Medicine, and fund grants for research into treatments for Alzheimers disease, cancer, spinal cord injuries and other diseases.

The institute has nearly used up its original funding, so Prop. 71s author, real estate investor and attorney Robert N. Klein II, led a new effort to get Prop. 14 on the November ballot.

This time, embryonic stem cell research is in a much different place, with federal funding no longer blocked and more funding from the biotech industry.

Voters will want to consider what Californias previous investment in stem cell research has accomplished. Its a nuanced track record.

While many scientific experts agree that Prop 71 was a bold social innovation that successfully bolstered emerging stem cell research, some critics argue that the institutes grantmaking was plagued by conflicts of interest and did not live up to the promises of miracle cures that Prop. 71s supporters made years ago. Although the agency is funded with state money, its overseen by its own board and not by the California governor or lawmakers.

The agency had done a very good job of setting priorities for stem cell research, including research using human embryos, and doling out $300 million annually to build up California as a regenerative medicine powerhouse, according to a 2013 evaluation by the National Academies of Science, Engineering and Medicine.

But the report also found that because the institutes board is made up of scientists from universities and biotech firms likely to apply for grants, board members had almost unavoidable conflicts of interest.

Keep tabs on the latest California policy and politics news

Because human stem cells can develop into many types of cells, including blood, brain, nerve and muscle cells, scientists have long looked to them for potential treatments for currently incurable diseases and injuries. Researchers use two types of stem cells: embryonic stem cells, derived from unused human embryos created through in vitro fertilization, and adult stem cells, which are harder to work with but in some cases can be coaxed in a lab into behaving more like embryonic stem cells.

From the start, stem cell research has been ethically charged and politically controversial because human embryos are destroyed in some types of studies. Federal restrictions on the research have waxed and waned, depending on which political party holds power. While former President Bush restricted federal money for embryonic stem cell research, former President Obama removed those restrictions.

The Trump administration has restricted government research involving fetal tissue but not embryonic stem cells. However, anti-abortion lawmakers have called on the President to once again end federal funding for embryonic stem cell research.

California-funded research has led to one stem cell treatment for a form of Severe Combined Immunodeficiency known as the bubble baby disease. Children with the rare disease dont make enough of a key enzyme needed for a normal immune system. Without treatment, they can die from the disease if not kept in a protective environment. The U.S. Food and Drug Administration is now reviewing the treatment but has not yet approved it for widespread use.

Although many of the agencys early grants were for basic science, the institute also has supported 64 clinical trials of treatments for many types of cancer, sickle cell disease, spinal cord injuries, diabetes, kidney disease and amyotrophic lateral sclerosis, commonlyknown as Lou Gehrigs disease.

A June 2020 analysis by University of Southern California health policy researchers estimated that taxpayers initial $3 billion investment in the research institute helped create more than 50,000 jobs and generated $10 billion for the states economy.

Gov. Gavin Newsom has endorsed Proposition 14, and other supporters include the Regents of the University of California, the California Democratic Party, the Juvenile Diabetes Research Foundation, patient advocacy groups like the March of Dimes, and some local politicians and chambers of commerce.

Supporters have raised more than $8.5 million, including about $2 million from billionaire Dagmar Dolby, to pass the measure, according to California Secretary of State campaign finance reports.

The passage of Proposition 71 helped save my life, Sandra Dillon, a blood cancer patient, wrote in a San Diego Union-Tribune commentary supporting Proposition 14. She wrote that she had benefited from a drug developed with Institute-funded research that has been designated by the FDA as a breakthrough therapy.

It is unimaginable to think that Californians would vote to discontinue this amazing effort I dont know where I would be or what condition I would be in if it wasnt for the investment Californians made nearly two decades ago.

I think the agencys done good work, but this was never planned to be funded forever with debt.

Lawrence Goldstein, a UC San Diego professor of cellular and molecular medicine and stem cell researcher, said the grants were instrumental in furthering his research on treatments for Alzheimers disease and that Prop. 14 will help create new jobs. The agency has funded a great deal of very important stem cell medical research thats already produced terrific results and has the prospect of saving many more lives in the decade to come, he said.

Opponents include one member of the institutes board and a nonprofit that advocates for privacy in genetic research. They contend that the proposition seeks too much money and does not sufficiently address the conflicts of interest that cropped up after Prop. 71 was passed. They also note that private funding, including venture capital, for stem cell research has grown in recent years. Opponents had raised only $250 by late September, from a single contribution by the California Pro Life Council.

The editorial boards of some of Californias biggest newspapers also have opposed the measure, including the Los Angeles Times, the Orange County Register, the San Francisco Chronicle and the San Jose Mercury News/East Bay Times. The Fresno Bee, Modesto Bee, and San Luis Obispo Tribune newspaper editorial boards support Prop 14.

Jeff Sheehy, the only institute board member not to support Proposition 14, told CalMatters that the research environment has changed since voters initially approved state funding for stem cell research in 2004 and that California should prioritize other needs like education, health care, and housing.

I think the agencys done good work, but this was never planned to be funded forever with debt, Sheehy said. At this point the state cant afford it; were looking at a huge deficit.

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Prop. 14: In the COVID age, can California still afford its stem cell research program? - CALmatters