No on Prop 14: Not the best way to support stem-cell research – Los Angeles Times

In 2004, after President George W. Bush cut off all federal funding for embryonic stem-cell research on religious grounds, Californians strongly backed Proposition 71, a $3-billion bond measure to fund this kind of research, even though such funding is usually not the purview of states.

Supporters of the proposition including this editorial board believed it would allow California to stand out as a leader in this field, advance a budding avenue of research that might save lives and alleviate suffering, bolster its biotech sector and fund possible blockbuster treatments that might earn the state royalties as well. Embryonic stem cells are particularly valuable to research because they are undifferentiated, meaning they do not have a particular function, and researchers could conceivably turn them into specialized cells in order to regenerate human cells and tissue.

In the years since, Proposition 71 gave rise to a burst of scientific discovery. Two cancer treatments it helped fund, for blood and bone-marrow cancers, have been approved by the FDA, though neither of those employed embryonic stem cells and could have been funded even under Bush administration rules. It has also supported promising advances in the treatment of diabetes, bubble boy immune deficiency and vision-robbing retinitis pigmentosa, but other efforts have fallen short in clinical trials.

Moreover, the money helped build laboratories and other infrastructure that give California a head start on research and development, making the state the it place for stem-cell research. Researchers in the state moved to the head of the pack for private grants, because projects are less likely to need the time and money to create facilities before work can begin.

Now that Proposition 71 funding has practically run out, the issue is back on the November ballot with Proposition 14, which seeks nearly double the amount worth of bonds $5.5 billion to continue the juggernaut.

This time, voters should reject the measure, with the caveat that the issue could be reconsidered in a couple of years, if its proponents bring it back in better-designed and more modest form and if there are more successes in human trials and financial payback.

We have long had reservations about how the California Institute for Regenerative Medicine, established as a result of Proposition 71, was set up. Though funded publicly, it is not overseen by the governor and Legislature like other state agencies, and its governing board is too large, at 29 members. Those members generally have ties to the advocacy organizations and research institutions that have received most of the money.

The driving force behind the initiative has been Robert N. Klein II, a Bay Area lawyer and real estate investor. There is no doubting Kleins sincerity in his cause. He knows too well the suffering inflicted by intractable diseases; his son Jordan died of complications of Type I diabetes in 2016. His accomplishment in persuading the state to invest billions in a specific avenue of biomedical research has been exceptional.

However, Klein developed these initiatives largely behind closed doors with little to no public input; he has strong ideas about how things should be run on the stem-cell front and has steadfastly resisted more government oversight. Thats fine when hes investing his own money; its a fatal flaw when he is asking voters for nearly $8 billion, the estimated cost of paying off the bonds over time, according to the Legislative Analysts Office.

Kleins role and the bloated structure of CIRMs super-sized governing board have given rise to some serious ethical mishaps, including a board member who improperly intervened to try to get funding for his organization. (He is no longer on the board.) After this and several other examples of impropriety, rules were tightened. Board members must recuse themselves from votes when there is a conflict of interest, but with 29 members who all want certain projects to receive funding, there is too much potential for mutual back-scratching. Instead of repairing this problem, the new proposition would expand CIRMs board to 35 members and retain its troubling independence from oversight by the governor and Legislature, leaving it open to further conflicts of interest.

Proposition 71 hasnt yet yielded a significant financial return on investment for the state or the cures that were ballyhooed at the time. Though no one ever promised quick medical miracles, campaign ads strongly implied they were around the corner if only the funding came through. Proponents oversold the initiatives and voters cant be blamed if they view this new proposal with skepticism.

In the years since Proposition 71 passed, more resources have become available. President Obama reversed Bushs order and restored federal funding, which meant that between CIRM and the National Institutes of Health, along with private grant and investment funding, stem-cell research has been healthy, if not downright flush. That funding has stayed and even grown under President Trump, to more than $2 billion a year, with about $321 million of that in human embryonic stem-cell research. (There have, though, been recent threats to embryonic research from a group of conservative senators.)

The idea was never for California to become the long-term replacement for federal funding. It was to kick-start an industry that would then operate on its own. If that has failed to happen under Proposition 71 as promised, it shouldnt be the responsibility of California taxpayers to fix it. Thats especially true right now, at a time of yawning needs to address the cost of twin health and economic crises and the worsening effects of climate change. Private money for stem cell-work will continue to be available; its not as though research will collapse.

No doubt, the pace of responsible science is incremental and the outcomes uncertain even with the best research efforts. Yet the backers still couch the possibilities in grandiose terms. In a recent interview with the Times editorial board, Klein talked about the money that would be saved by wiping out Alzheimers disease which has so far has frustrated attempts to treat it effectively, despite many billions of dollars in research.

Embryonic stem cell research remains important, and there might be ways in which the state can contribute less grandiose funding while maximizing its investment. For example, scientific research has a well-known valley of death, where many projects cant get funding to make the transition from laboratory to human clinical trials.

Offering some matching help to get projects through that phase might attract businesses and scientists to California, while spending far less than the billions proposed in Proposition 14. Its worth noting that stem-cell work isnt the only kind of research that faces the valley of death problem; its an issue for most basic research that seeks to make the leap to human trials and that might be equally in need of state help.

Now is not the time for a huge new investment in specialized medical research. First, it makes sense to wait until after the election; if Democrats do well, there should be growing support for embryonic stem-cell research at the federal level, which is where such funding should take place. The future of Californias pandemic-battered economy and budget remains to be seen. Waiting also would give voters a chance to find out how well the states stem-cell research projects continue without state dollars, and whether some of the promising advances lead to breakthrough therapies and a return on Californias investment.

There would be an opportunity to rethink and rewrite any future proposals, which should include a far more modest ask of taxpayers as well as fixes to the structure and inflated size of the CIRM board. The institute should also be placed under the same state oversight as other agencies reporting to the governor.

If CIRM needs money for a basic operating budget over the next couple of years, that could be covered by the states general fund. The agency still needs to administer already-funded projects and could use that time to discuss a more affordable path forward. Right now, the state has other, more urgent spending priorities.

Editors note: This newspapers owner, the physician and scientist Dr. Patrick Soon-Shiong, played no role in the editorial boards deliberations on this measure.

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No on Prop 14: Not the best way to support stem-cell research - Los Angeles Times

Vitro Biopharma 3rd Quarter ended July 31st 2020 Financial Results of Operations – BioSpace

GOLDEN, CO / ACCESSWIRE / October 1, 2020 / Vitro Diagnostics, Inc. (OTCQB:VODG), dba Vitro Biopharma, announced its 3rd quarter, ended July 31st 2020, financial results of operations.

Vitro Biopharma recorded 3rd quarter revenues of $132,066 vs $225,191 a decrease of 41% over the comparative quarter last year. Revenues were up slightly from the prior quarter which were $128,631. The decrease in revenue is directly attributed to the COVID 19 pandemic. Lockdown extensions and business opening limitations have pushed our expectations of growth and revenue recovery out to the first half of 2021. Feedback from our customers and our partner clinic in the Cayman Islands http://www.DVCstem.com are that patients awaiting treatments are not dropping off, but merely postponing their treatments and as such, a significant backlog is building. The cosmetic clinics http://www.Infinivive.com have started to open up but only with lower occupancy and variations by state, resulting in reduced revenue into the 4th quarter with expectations of a revival of revenue into the first half of 2021.

Gross profit declined 3% from the comparative quarter last year primarily due to the reduced higher margin stem cell product sales versus the mid margin stem cell research and development products.

Overall operating expenses increased in the quarter ended July 31st 2020 by $180,326 to $336,442 from $194,682 in the prior year's comparative quarter. The increase in expenses reflects the increased costs of FDA regulatory, legal, consulting, and audit costs. We engaged the audit firm of MaloneBailey LLP to get the company fully reporting around January of 2021.

Vitro Biopharma Announces MaloneBailey L.L.P. as its new Auditors

The company added extra resources to turn its attention to the world-wide challenge of finding therapies to fight COVID-19. Vitro filed an Investigational New Drug ("IND") application and through its collaboration with GIOSTAR, received FDA authorization to treat COVID 19 patients under the Expanded Access Program with its AlloRx Stem Cells . A single patient was treated successfully with no adverse events and the patient showed evidence of improved lung, liver and kidney function while also recovering from a stroke-induced coma.

Critically ill COVID-19 Patient Successfully Treated with Vitro Biopharma’s AlloRx Stem Cells®

The company entered into an MOU with GIOSTAR, a leading global stem cell research company, who operates multiple international stem cell clinics. The supply agreement provides GIOSTAR with the use of our AlloRx Stem Cells to treat COVID 19 patients through FDA-pre and post-market approval.

Vitro Biopharma Signs MOU with GIOSTAR for COVID-19 IND Using AlloRx Stem Cells

During and subsequent to the quarter the company achieved and pursed the following objectives:

During the quarter and subsequent to the quarter, the company continued with its Series A Convertible Preferred Stock offering to accredited investors under the SEC Regulation D exemption. The preferred Stock is priced at $25 per share which is convertible at $0.25 cents per share for a total of 100 shares. The minimum investment is $50,000 per unit. The company has sold $1.0 million of the Series A Convertible Preferred Stock during and subsequent to the quarter. The offering was sold out at $1.0 million and the company has expanded it to a total of up to $3.5 million to ensure sufficient working capital during the Coronavirus pandemic and to start the regulatory process of current reporting audits and funding for its expanded clinical trial activities with the FDA.

As a part of our overall strategy to target both global and US stem cell markets, Vitro submitted a Phase I IND application to the FDA to assess the safety of AlloRx Stem Cells in the treatment of COVID-19. We have established strong communication channels with FDA officials to facilitate our IND review and are providing additional information to the FDA to complete the approval of our IND. Several clinical centers have expressed interest in our stem cell therapy and we continue to enlist multi-center sites to conduct our Phase 1 trial. We are also pursuing other avenues for emergency use under the Expanded Access Program. No adverse events were reported and the patient who had various comorbidities stabilized and exhibited enhanced pulmonary, liver and renal function during the six weeks following AlloRx Stem Cell Therapy. The patient has now recovered and is at home from the hospital after 3 months of intensive care. We are currently pursuing additional emergency use authorizations under expanded access provision applications through our collaboration with GIOSTAR. MSCs have been shown to block the cytokine storm that occurs in COVID-19 patients in acute respiratory distress through their powerful anti-inflammatory effects. The cytokine storm leads to the need for assisted breathing by ventilators, transfer to ICU and related burdens on the US health care system. It is important to note that AlloRx Stem Cells are a possible therapy for other viral attacks including influenza. Stem cells may block acute respiratory distress and may repair damage to other major organs including cardiovascular, pulmonary, hepatic and renal systems. AlloRx Stem Cells have been shown to assist in recovery from failure of various organ systems in COVID-19 survivors, as our case study and results from several other labs are demonstrating.

The Company entered into an exclusive Memorandum of Understanding (MOU) with Global Institute of Stem Cell Therapy and Research, Inc. ("GIOSTAR") a leading stem cell research institute based in San Diego, California. GIOSTAR has filed for a separate IND application using Vitro Biopharma's umbilical cord mesenchymal stem cell product AlloRx Stem Cells in a clinical trial to treat COVID-19 patients. GIOSTAR has already obtained emergency use authorization under expanded access provisions from the FDA for severe COVID-19 hospitalized patients using AlloRx Stem Cells.

Vitro continues to seek FDA authorization of its pending IND. As the approval process proceeds, Vitro will seek AlloRx Stem Cells FDA approval through Phase 2/3 IND filings for other indications such as osteoarthritis while at the same time continuing to supply GIOSTAR AlloRx Stem Cells for treatment of COVID-19 patients in global markets.

The company has delayed the expansion of its laboratory and manufacturing facilities to better reflect the delays in revenue brought on by the pandemic. This new facility is expected to be operating in the second half of 2021. Our present facility has approximately $6M of AlloRx Stem Cell Vitro Biopharma revenue capacity per year. Furthermore, the completion of the 2nd clean room processing facility would expand our potential capacity to approximately 100 Billion AlloRx Stem Cell s a month or approximately $1.7 Million of AlloRx Stem Cell revenue capacity per month. This would give Vitro Biopharma a revenue run rate capacity of $20M a year.

Our increased capacity is rigorously controlled by our Quality Management System, now certified to the ISO9001 Quality Standard and the ISO13485 Medical Device Standard as well. This provides cGMP-compliant manufacturing of the highest quality stem cells/medical devices for clinical trial testing to provide further evidence of safety and efficacy for treatment of a wide variety of indications. Highly regulated cGMP biologics manufacturing within a BLA-compliant facility provides numerous opportunities to the Company to drive strong revenue growth. We are presently focused on our partnerships in the Caribbean with DVC Stem in Grand Cayman Island, InfiniVive MD in the US and emerging opportunities in the The Medical Pavilion of the Bahamas We are actively pursuing other partnership opportunities as well.

We have reformulated with our contract manufacturer to produce STEMulize in large quantity manufacturing runs. STEMulize contains natural substances that activate the body's own stem cells to enhance recovery from injury such as TBI, stroke, MS, PD and other autoimmune, inflammatory and neurological diseases. The STEMulize product will be offered as a private label product to Infinivive MD clinics and is being implemented as supplemental support to clinical treatments now ongoing in the Cayman Islands. Patients report positive benefits fromSTEMulize therapy following stem cell transplants including increased overall energy and enhancement of improved motor function in MS patients. We are currently pursing licensing arrangements with nutraceutical companies that can scale our formulation under their own private label.

The Company's cosmetic stem cell serum private labelled as Infinivive MD is being applied as a topical cosmetic serum in medical spas and plastic surgery offices. Infinivive MD revenue was reduced by the Coronavirus pandemic and as a result, revenues declined by 52% in the current quarter to approximately $50,000 vs $105,000 in the prior comparative quarter in 2019. This revenue has been flat from the prior quarter reflecting the reduced treatments due to the pandemic capacity limitations of various states.

Infinivive MD Cosmetic Serum is revolutionizing the cosmetic industry. Patients are experiencing unparalleled improvements in the appearance of fine lines and wrinkles. This is one of the fastest growing revenue streams for Vitro Biopharma.. We work with a variety of regulatory experts to assist us in the appropriate regulatory pathways.

http://www.jackzamoramd.com http://www.infinivivemd.com

Vitro Biopharma's OEM cosmetic topical serum is being distributed exclusively by Infinivive MD into cosmetic clinics that are providing the topical treatment as a beautification product. To date the company's product is being offered in a number of clinics throughout the United States and soon internationally,; but with the clinics just opening again for business and with limited occupancy rules we do not expect this revenue to recover back to peak levels with growth until the first half of 2021.

The company has brought on Dr. Jack Zamora as its chief medical officer (C.M.O.) and together we have developed a new exosome product, Infinivive MD's Cosmetic Exosome Serum.

Vitro Biopharma Announces Jack Zamora M.D. as it’s Chief Medical Advisor

The product will be distributed by InfiniveMD along with the topical stem cell serum. The product is also used as a topical application for beautification. The product is a compliment to the topical stem cell serum and will provide the customer with a more competitive price point per application depending on the particular clinic. The new Exosome product

is being marketed and sold into the clinics in the first half of 2021. We are jointly working

on a topical Daily Serum. The Exosome market is part of the billion-dollar cosmetic market in the United States. These products will also be sold offshore around the world.

Update on the Clinical Trial of Musculoskeletal Conditions in the Bahamas

This initiative broadens Vitro Biopharma's expansion into highly regulated stem cell trials in collaboration with the Nassau-based Medical Pavilion of the Bahamas (TMPB).

Home

We will now be able to extend stem cell therapy based on our novel, patent-pending AlloRx Stem Cell product to a variety of musculoskeletal conditions. These include OA of any joint, ACL/MCL tear, Achilles tendon rupture, rotator cuff injury, tennis elbow and herniated disc that are highly prevalent and have few disease-modifying options. It is important to note that many stem cell treatments now performed are problematic due to limited potency and failure to meet basic criteria of stem cells. Vitro Biopharma operates a highly regulated, FDA-compliant commercial biologics manufacturing operation for several years and is cGMP compliant, ISO 9001Certified, ISO 13485 Certified, CLIA Certified and FDA registered and BLA-compliant. All manufacturing occurs in a certified sterile clean room with extensive and advanced testing to assure the absence of contamination. Furthermore, in numerous patients treated to date by IV infusion of AlloRx Stem Cells there have been no significant adverse events. The company is partnered with Dr. Conville Brown, MD, MBBS, FACC, FESC, PhD, the founder and CEO of the Medical Pavilion of the Bahamas who is the Principal Investigator of this trial and director of its clinical administration. Dr Brown was instrumental in the establishment of the NSCEC in the Bahamas.

About the Medical Pavilion of the Bahamas: TMPB operates within a 40,000 square foot building as a partnered care specialty medical facility with 10 different centers in various areas including cardiology, cancer, clinical research and kidney disease. One of the centers is the Partners Stem Cell Centre, where the present trial will be conducted. The Partners Stem Cell Centre provides an environment to conduct stem cell research and clinical trials under the model of ''FDA rigor in a Non-FDA Jurisdiction'' TMPB employs 20 medical specialists in various fields. See http://www.tmp-bahamas.com for additional information.

The company has entered into an operating agreement with the Partner's Stem Cell Centre and expects to begin patient enrollment for the clinical trial in QI/QII of 2021 once

the Bahamas opens up without quarantine restrictions.

Due to the Corona virus pandemic the Cayman Islands closed itself and its businesses down for the majority of the quarter and next quarter, the current status is listed as locked down until Oct. 1st 2020. However, our partner reports that customers are staying on the waiting list and will return for their treatments as soon as the island opens back up. There currently is a pending backlog of over 70 patients seeking treatment which exceeds all of the treatments performed in 2019 by over 200%. We expect to see a surge in revenues from this backlog to bring back our revenue stream in the into the first half of 2021.

The Company has 11 patent applications pending in the US and foreign jurisdictions. These patents cover our AlloRx Stem Cell line and various aspects of our STEMulize stem cell activation products and processes as well as specific diagnostic tests of stem cell activity and therapeutic effectiveness. During the quarter, the Company has responded to office actions and continues to vigorously prosecute & expand its patent filings.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are pleased to report our activities in fighting the COVID-19 with filings of our eIND, INDs and partnership with GIOSTAR. While we are disappointed in the extraordinary events of the Corona Virus pandemic and its results on our operations, we have taken the time to advance our clinical applications, partnerships and new product development in further preparation for realized growth in 2021 as a result of these activities. In addition, with have started the intense process of organizing the company for audits and fully reporting status with the SEC targeted for January 2021.

We believe our stem cell products are distinctly superior to stem cell treatments offered in the USA. The latter usually involve use of impure products lacking validation as stem cells and containing insufficient numbers of stem cells to achieve therapeutic benefits. These are produced without regulatory oversight and have been known to cause serious adverse effects. Hence the use of highly purified and well characterized stem cells (AlloRx Stem Cells) is needed to provide safety and efficacy in regenerative medicine therapies.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10+ years' experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapy. We plan to leverage our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide.

Vitro Biopharma has supplied major biopharmaceutical firms, elite university laboratories and clinical trials worldwide with its Umbilical Cord Mesenchymal Stem Cells (AlloRx Stem Cells), and it's MSC-Grow Brand of cell culture media along with advanced stem cell diagnostic services. http://www.vitrobiopharma.com"

Sincerely yours,

James R. Musick, PhD.

President, CEO & Chairman of the Board

http://www.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends,"

"anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures.

Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements.

Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James Musick 4621 Technology Drive Golden, CO 80403 (303) 999-2130 x1 http://www.vitrobiopharma.com

Vitro Diagnostics, Inc.

Quarter Ended July 31st;

Income Statement

Stem Cell Therapies and Treatments

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Non Cash Stock for Services

Non Cash Interest on Shareholder Debt

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The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

Vitro Diagnositics Inc.

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SHAREHOLDERS EQUITY

Series A Convertible Preferred

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Vitro Biopharma 3rd Quarter ended July 31st 2020 Financial Results of Operations - BioSpace

Asymmetrex Presents the Value of Tissue Stem Cell Counting For Supplying Stem Cell Clinical Trials and Drug Development Clinical Trials – PR Web

Asymmetrex discusses new advances for supply of traditional drug development and advanced therapy medicinal product (ATMP) clinical trials

BOSTON (PRWEB) October 01, 2020

Adapting to the present COVID crisis, this year the 2020 Outsourcing in Clinical Trials USA Conference, one of several international clinical trials supply trade conferences organized by Arena International Events Group each year, adopted a virtual meeting format. The conference, scheduled for September 30-October 1, continued its tradition of bringing together contract research organization suppliers and company sponsors in the clinical trials supply industry to discuss new developments and best practices.

Among the many industry members invited to speak in the event, James L. Sherley, M.D., Ph.D., founder and director of Massachusetts stem cell biotechnology company Asymmetrex, presented on September 30. Dr. Sherleys presentation highlighted a growing new area of the clinical trials supply industry. More and more, the clinical trials supply industry is considering better technology and practices to support stem cell clinical trials and gene therapy clinical trials that utilize advanced therapy medicinal products. In particular, Dr. Sherley discussed the value of implementing new quantification technologies for ATMPs developed with tissue stem cells. He answered the rhetorical question that was the title of his talk How can we outsource stem cell clinical trials without counting tissue stem cells? by detailing places in ATMP supply chains where instituting counting technologies would provide significant benefits to the stem-gene clinical trials supply industry and the patients it serves.

Sherley also presented innovation proposals for traditional pharmaceutical and biopharmaceutical clinical trials supply. He described how tissue stem cell counting technologies represented advantages both for discovery of novel drugs and for toxicology evaluations of new drug candidates. A major value presented was the opportunity for drug companies to realize hundreds of millions of dollars in reduced costs each year by using tissue stem cell counting tests for earlier identification of drugs that would fail late in clinical trials because of inducing chronic failure of organs and tissues like the liver and bone marrow. Currently applied animal toxicology studies miss many drugs with this disastrous character. Sherley described how such drugs could be detected in inexpensive cell culture tests by counting how stem cell-specific number and viability changed in their presence.

Though not a main focus of the presentation, Sherley ended his presentation with acknowledgement of Asymmetrexs recent introduction of the first-in-kind technology for counting therapeutic tissue stem cells and determining their dosage. The company holds issued patents for the technology and its use for drug evaluations in both the U.S. and U.K. In August of this year, it published a peer-reviewed report, co-authored with its partner AlphaSTAR Corporation, that describes the new method and its applications for stem cell therapy and drug evaluations. In September, the company was awarded a research and development grant from the National Institutes of Health-National Heart, Lung, and Blood Institute for continued development of the technology and its commercialization. These plans for the companys AlphaSTEM Test tissue stem cell counting technology were recently reported.

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The companys U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems production and quantification that have stood in the way of effective use of human adult tissue stem cells for regenerative medicine and drug development. Asymmetrex markets the first technology for determination of the dose and quality of tissue stem cell preparations (the AlphaSTEM Test) for use in stem cell transplantation therapies and pre-clinical drug evaluations. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA and the Massachusetts Biotechnology Council.

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Asymmetrex Presents the Value of Tissue Stem Cell Counting For Supplying Stem Cell Clinical Trials and Drug Development Clinical Trials - PR Web

Stem cells can repair Parkinson’s-damaged circuits in mouse brains – University of Wisconsin-Madison

The mature brain is infamously bad at repairing itself following damage like that caused by trauma or strokes, or from degenerative diseases like Parkinsons. Stem cells, which are endlessly adaptable, have offered the promise of better neural repair. But the brains precisely tuned complexity has stymied the development of clinical treatments.

In a new study addressing these hurdles, University of WisconsinMadison researchers demonstrated a proof-of-concept stem cell treatment in a mouse model of Parkinsons disease. They found that neurons derived from stem cells can integrate well into the correct regions of the brain, connect with native neurons and restore motor functions.

The key is identity. By carefully tracking the fate of transplanted stem cells, the scientists found that the cells identity dopamine-producing cells in the case of Parkinsons defined the connections they made and how they functioned.

Coupled with an increasing array of methods to produce dozens of unique neurons from stem cells, the scientists say this work suggests neural stem cell therapy is a realistic goal. However, much more research is needed to translate findings from mice to people.

Su-Chun Zhang talks with a postdoctoral student in his research lab at the Waismam Center. Photo: Jeff Miller

The team, led by UWMadison neuroscientist Su-Chun Zhang, published its findings Sept. 22 in the journal Cell Stem Cell. The research was led by Zhang lab postdoctoral researchers Yuejun Chen, Man Xiong and Yezheng Tao, who now hold faculty positions in China and Singapore.

Our brain is wired in such an accurate way by very specialized nerve cells in particular locations so we can engage in all our complex behaviors. This all depends on circuits that are wired by specific cell types, says Zhang, a professor of neuroscience and neurology at UWMadisons Waisman Center. Neurological injuries usually affect specific brain regions or specific cell types, disrupting circuits. In order to treat those diseases, we have to restore these circuits.

To repair those circuits in the Parkinsons disease mouse model, the researchers began by coaxing human embryonic stem cells to differentiate into dopamine-producing neurons, the kind of cells that die in Parkinsons. They transplanted these new neurons into the midbrains of mice, the brain region most affected by Parkinsons degeneration.

Several months later, after the new neurons had time to integrate into the brain, the mice showed improved motor skills. Looking closely, Zhangs group was able to see that the transplanted neurons grew long distances to connect to motor-control regions of the brain. The nerve cells also established connections with regulatory regions of the brain that fed into the new neurons and prevented them from being overstimulated.

Both sets of connections feeding in and out of the transplanted neurons resembled the circuitry established by native neurons. This was only true for dopamine-producing cells. Similar experiments with cells producing the neurotransmitter glutamate, which is not involved in Parkinsons disease, did not repair motor circuits, revealing the importance of neuron identity in repairing damage.

To finally confirm that the transplanted neurons had repaired the Parkinsons-damaged circuits, the researchers inserted genetic on-and-off switches into the stem cells. These switches turn the cells activity up or down when they are exposed to specialized designer drugs in the diet or through an injection.

When the stem cells were shut down, the mices motor improvements vanished, suggesting the stem cells were essential for restoring Parkinsons-damaged brains. It also showed that this genetic switch technology could be used to fine-tune the activity of transplanted cells to optimize treatment.

Zhang found that neurons derived from stem cells can connect with native neurons and restore motor functions. But more research is needed to translate the findings from mice to people.

The Zhang group and other researchers have spent years developing methods to turn stem cells into the many different types of neurons within the brain. Each neurological disease or injury would require its own specialized nerve cells to treat, but the treatment plans would likely be broadly similar. We used Parkinsons as a model, but the principle is the same for many different neurological disorders, says Zhang.

The work has personal meaning to Zhang. As a physician and scientist, he often receives letters from families desperate for help treating neurological disorders or brain trauma. Its also an experience he can relate to. Six years ago, Zhang was in a bike accident and broke his neck. When he awoke partially paralyzed in the hospital, his first thought was of how stem cells which he had already researched for years could help him recover.

Now, largely rehabilitated after years of physical therapy, Zhang still believes that the right stem cell treatments could, in the future, help people like him and the families he hears from.

To that end, Zhangs group is currently testing similar treatments in primates, a step toward human trials.

There is hope, but we need to take things one step at a time, he says.

This work was supported in part by the National Institutes of Health (grants NS096282, NS076352, and NS086604, MH099587 and MH100031).

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Smith’s 2005 stem cell law to be reauthorized by House – InsiderNJ

Smiths 2005 stem cell law to be reauthorized by House

Rep. Chris Smith (R-NJ)statement submitted during debate in the House of Representatives

on the Stem Cell Therapeutic and Research ActSeptember 29, 2020

Margaret Hahnmy mother-in-lawpassed away on Friday and a Mass of Christian burial will be held today at St. Mary Church in South Amboy, New Jersey. She was 96 and was deeply loved and will be deeply missed.

MargaretPegwas a great womanwife, mother, grandmother, and great-grandmother. She selflessly devoted her life to public service including her amazing work as Sayreville Borough Clerk for twenty years. She had an incredible reputation for getting things done for the people. No matter who served as mayor or on Council, everyone knew she was the power.

My wife Marie and I will join family and friends today at her funeral and internment making it impossible for me to speak today during the debate on the reauthorization of a law I originally authored fifteen years agothe Stem Cell Therapeutic and Research Act of 2005and the Stem Cell Therapeutic and Research Act of 2015.

So, I submit these comments for the Congressional Record.

Madam Speaker, today the House of Representatives will vote to reauthorize the Stem Cell Therapeutic and Research Act.

This was an original idea of mine 20 years ago. Joined by 70 cosponsors, I introduced it in 2001 and again in 2003.

After five long years of hard work and numerous setbacks, my bill was finally enacted into law in 2005.

Beginning in 2001, Dr. Joanne Kurtzberg, who is President of the Cord Blood Association, helped draft my original law.Dr. Kurtzberg has said, Cord blood transplantation is now an established field with enormous potential. In the future, it may emerge as a source of cells for cellular therapies focused on tissue repair and regeneration.

The new law created a nationwide umbilical cord blood stem cell program, designed to collect, derive, type, and freeze cord blood units for transplantation into patients to mitigate and to even cure serious disease. Pursuant to the law, it also provided stem cells for research. The new cord blood program was combined in our 2005 law with an expanded bone marrow initiative, which was crafted over several years by our distinguished colleague, CongressmanBill Young.

I was the prime sponsor again when it was reauthorized in 2015.

Umbilical cord blood stem cells, obtained after the birth of a child, have proved highly efficacious in treating 70 diseases, including sickle-cell disease, lymphoma, and leukemia. And scientists are continuing to study and better understand the regenerative effects of cord blood cell therapies for other diseases and conditions. Bone marrow donations provide lifesaving transplants to treat diseases like blood cancer, sickle cell anemia, or inherited metabolic or immune system disorders.

The National Cord Blood Inventory (NCBI) provides funding to public cord blood banks participating in the program to allow them to expand the national inventory of cord blood units available for transplant. These units are then listed on the registry by the Be the Match Program. The funds appropriated thus far have led to an important increase in the overall number of high-quality cord blood units available through the national registry, including 150,000 NCBI units. Within the Be the Match registry, there are more than 783,000 NCBI units worldwide.

The Program registry allows patients and physicians to locate matching cord blood units, as well as adult donors for marrow and peripheral blood stem cells, when a family donor is not available. The Program is the worlds largest, most diverse donor registry, with more than 22 million volunteers and more than 300,000 public cord blood units. To date, the National Marrow Donor Program/Be The Match (NMDP), through its operation of the Program, has facilitated more than 100,000 transplants. More than 45,000 patients have receivedcord bloodtransplants, according Dr. Joanne Kurtzberg.

The reauthorization before us authorizes $23 million to be appropriated for fiscal year 2021 through fiscal year 2025. It also authorizes $30 million to be appropriated for fiscal years 2021 through 2025 for the bone marrow transplant program. This continues funding at the same levels authorized in the 2015 authorization bill.

Madam Speaker, each year nearly 4 million babies are born in America. In the past, virtually every placenta and umbilical cord was tossed as medical waste. Today, doctors have turned this medical waste into medical miracles.

Not only has God in His wisdom and goodness created a placenta and umbilical cord to nurture and protect the precious life of an unborn child, but now we know that another gift awaits us immediately after birth. Something very special is left behindcord blood that is teeming with lifesaving stem cells. Indeed, it remains one of the best kept secrets in America that umbilical cord blood stem cells and adult stem cells in general are curing people of a myriad of terrible conditions and diseasesover 70 diseases in adults as well as in children.

The legislation that is before us will enable even more patients to receive the treatments that they so desperately need.

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Smith's 2005 stem cell law to be reauthorized by House - InsiderNJ

Risk Based Therapy Approach for Sickle Cell Anemia Patients is Ideal Scenario – MD Magazine

Although the therapeutic options for sickle cell anemia have expanded over the past years, the clinical complications of the condition as well as the limitations of these pharmacotherapies have called for an urgent need to implement a personalized treatment strategy for patients that is based on risk stratification.

In a recent article, Emily Meier, MD, of the Indiana Hemophilia and Thrombosis Center, elucidated on the key considerations in the prescribing of such therapies as well as the current barriers that preclude healthcare providers from achieving an optimal treatment strategy for these patients.

With increasing therapeutic options, the ideal scenario for children with SCA would be one similar to childhood acute lymphoblastic leukemia (ALL) risk stratification: treatment intensity varies with risk level, Meier wrote.

Thus, children who are at low risk for sickle cell anemia complications would receive less intense therapies, which includes a continuation of hydroxyurea. On the other hand, those with the highest risk would be recommended to immediately receive one or more curative therapies, such as hematopoietic stem cell transplant, gene therapy, transfusion therapy, voxelotor, and/or crizanlizumab.

Of course, as Meier noted, there are certain limitations that must be considered before implementing such a strategy.

For one, crizanlizumab and voxelotor are approved for ages 16 and 12 years, respectively. According to the risk based therapy model, high-risk patients should only use both therapies once age appropriate.

Similarly, patients with medium risk of complications should only use L-glutamine once they reach the appropriate age of 5 years.

Additionally, there is no validated predictor for the overall severity of the disease prior to the onset of associated complications. Currently available predictors of a severe outcome is an abnormal velocity on transcranial Doppler ultrasonography. These predictors identity children at highest risk for stroke.

Meier noted that there are no predictors for vaso-occlusive episodes or acute chest syndrome.

Furthermore, there is no unanimous agreement of what constitutes severe sickle cell anemia. However, the inclusion criteria for hematopoietic stem cell transplant is considered a promising start.

Overall, Meier suggested that hydroxyurea should be the standard of care in pediatric and adult patients, regardless of disease severity.

In adults with sickle cell anemia, a risk-based strategy should still be utilized, but the end organ injury makes such an approach more challenging to implement.

She suggested that the additional FDA-approved treatments should be based on clinical and laboratory complications that are still present even after hydroxyurea dosing has been maximized.

According to the seminal trials in support of these agents, L-glutamine and crizanlizumab should be considered as additional therapy in patients who continue to experience vaso-occlusive episodes. Meier also encouraged the addition of voxelotor to hydroxyurea for those adults who continue to have significant anemia.

Hopefully, as the number of SCA modifying and curative therapies increase, more innovative treatment strategies will be tested and lead to improved quality of life and increased life expectancy for individuals with SCA, she concluded.

The opinion piece, What are the key considerations when prescribing pharmacotherapy for sickle cell anemia? was published online at Taylor & Francis Online.

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Risk Based Therapy Approach for Sickle Cell Anemia Patients is Ideal Scenario - MD Magazine

Platelet Rich Plasma and Stem Cell Alopecia Treatment Market -Key Players, Size, Growth, Incredible Potential, and Stagnant Progress According to New…

The global platelet rich plasma & stem cell alopecia treatment market report comprises an elaborate executive summary, including a snapshot that provides information on various segments of the market. It also provides information and data analysis of the global market with respect to segments based on treatment, indication, end-user, and region. A detailed qualitative analysis of drivers, restraints, and opportunities of the market has been provided in the market overview section. Additionally, the section comprises a competitive matrix and profiles of key market players, along with business overview, to project the competitive landscape of the market. The section also provides presence of key players working in the development of stem cell and platelet rich pharmaceutical products, thereby presenting a thorough analysis of the overall competitive scenario in the global platelet rich plasma & stem cell alopecia treatment market.

This report analyzes the current and future scenario of the global platelet rich plasma & stem cell alopecia treatment market for the period 2018 to 2026. Rise in awareness about platelet rich plasma therapies and stem cell therapies, increase in funding for alopecia treatment research and stem cell research, and increase in the incidence of autoimmune hair loss disorders are likely to be major drivers of the global platelet rich plasma & stem cell alopecia treatment market during the forecast period.

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Global Platelet Rich Plasma and Stem Cell Alopecia Treatment market Witness Most Promising Rise in Demand

The global platelet rich plasma & stem cell alopecia treatment market is expected to reach a value of approximately US$ 450.5 Mn by the end of 2026, expanding at a high single digit CAGR during the forecast period. Factors such as increase in demand for accurate and prompt treatment of alopecia and advancements in platelet rich plasma and stem cell therapies that have revolutionized the diagnostic science are likely to boost the market. Moreover, a rise in awareness about platelet rich plasma therapies and stem cell therapies is expected to drive the global market during the forecast period.

Increased awareness has driven demand for platelet rich plasma therapy & stem cell therapy in the past few years in countries such as Japan, India, Brazil, and Russia and developed regions such as North America and Europe. Additionally, private players are actively promoting the advantages of treatment of alopecia with stem cell therapy across the globe. A rise in the incidence rates of autoimmune hair loss disorders such as alopecia is estimated to boost the platelet rich plasma & stem cell alopecia treatment market. According to the Journal of Clinical, Cosmetic, and Investigational Dermatology, 2015, the lifetime incidence rate of alopecia areata is approximately 2% worldwide. This is expected to propel the market. However, a lack of treatment approval and high cost of alopecia treatment are likely to hinder the growth of platelet rich plasma & stem cell alopecia treatment market.

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Based on treatment, the global platelet rich plasma & stem cell alopecia treatment market has been segmented into platelet rich plasma therapy and stem cell therapy. The stem cell therapy segment has been further classified into bone marrow treatment and adipose treatment. In terms of indication, the global platelet rich plasma & stem cell alopecia treatment market has been classified into androgenic alopecia, congenital alopecia, cicatricial or scarring alopecia and others. Based on end-user, the global platelet rich plasma & stem cell alopecia treatment market has been divided into hospitals, dermatology clinics, and others. The market size and forecast for each of these segments have been provided for the period 2018 to 2026, along with their respective CAGR for the forecast period 2016 to 2026, considering 2017 as the base year.

Key Players of Platelet Rich Plasma and Stem Cell Alopecia Treatment Market Report:

Major players operating in the global platelet rich plasma & stem cell alopecia treatment market include Kerastem, Eclipse, Regen Lab SA, Stemcell Technologies, Inc., RepliCel Life Sciences, Histogen, Inc., and Glofinn Oy. Key players are focused on research & development of alopecia treatment by investing in platelet rich plasma & stem cell alopecia therapies. Mergers & acquisitions, collaborations, and partnerships are helping companies expand their footprint and further develop effective treatments for alopecia.

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Platelet Rich Plasma and Stem Cell Alopecia Treatment Market -Key Players, Size, Growth, Incredible Potential, and Stagnant Progress According to New...

Platelet Rich Plasma and Stem Cell Alopecia Treatment Market Analysis by Size, Share, Growth, Application, Segmentation and Forecast to 2025 – The…

Global Platelet Rich Plasma and Stem Cell Alopecia Treatment Market report 2020 gives a complete detail of key drivers, leading market players, key segments, and regions. Besides this, the experts have extremely studied diverse geological areas and presented a competitive scenario to assist new entrants, leading market players, and investors to determine emerging economies. These insights offered in the Platelet Rich Plasma and Stem Cell Alopecia Treatment report would benefit market players to plan strategies for the outlook and gain a well-built position in the global Platelet Rich Plasma and Stem Cell Alopecia Treatment market growth.

The study of Platelet Rich Plasma and Stem Cell Alopecia Treatment market highlights important aspects such drivers, challenges, restraints, and expansion prospects prevailing in this particular industry sphere.

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As per the report, Platelet Rich Plasma and Stem Cell Alopecia Treatment market is projected to grow substantially with XX% CAGR over 2020-2025, which is poised to amass momentous returns by the end of analysis timeframe.

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The nation-wide lockdown, travel bans, and movement restrictions, in every part of the world, to curb COVID-19 spread, are believed to have doomed many industries. Consequently, all companies are revising their finances and business strategies to incorporate the set-up over the forthcoming period. With our thorough analysis of this marketplace, we offer recommendations to frame robust contingency plans in order to nullify business uncertainties.

The report further entails a comprehensive scrutinization of various segmentations, enabling the reader to understand the overall impact on market dynamics.

Major highlights of Platelet Rich Plasma and Stem Cell Alopecia Treatment market report:

List on segments in Platelet Rich Plasma and Stem Cell Alopecia Treatment market report:

Geographical landscape: North America, Europe, Asia-Pacific, South America and Middle East & Africa

Product terrain: Androgenic Alopecia, Congenital Alopecia and Cicatricial Or Scarring Alopecia

Application scope: Hospital, Dermatology Clinic and Other

Competitive hierarchy: Kerastem, Stemcell Technologies, Eclipse, Glofinn Oy., Regen Lab SA, Histogen and RepliCel Life Sciences

Key questions answered in the report:

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Platelet Rich Plasma and Stem Cell Alopecia Treatment Market Analysis by Size, Share, Growth, Application, Segmentation and Forecast to 2025 - The...

Timothy Ray Brown, First Person to Be Cured of HIV, Dies – The Scientist

Timothy Ray Brown, who became the first HIV patient to be cured of the infection, died September 29 of leukemiathe very disease that led to the fortuitous eradication of the virus from his body. He was 54.

Until he disclosed his identity, Brown was known as the Berlin patient, whose HIV infection was eliminated in 2007 after undergoing a stem cell transplant to treat acute myeloid leukemia. The bone marrow donor was selected to have a naturally occurring genetic variant that blocked HIV from entering cells. The treatment workedboth for his cancer, and his viral infection.

Timothy symbolized that it is possible, under special circumstances to cure HIV, Gero Htter, the doctor who performed the stem cell transplant, tells theAssociated Press.

Until2016, Brown remained the only person in the world to have been cured of AIDS using this approach and his unique experience motivated him to advocate for AIDS research. As he toldThe Scientist in 2015, I didnt want to be the only one in my club.

Brown was born in 1966 and grew up in Seattle. He was living in Berlin when he received the diagnosis of leukemia and sought treatment from Htter. The doctor had previously read about individuals with variants in the CCR5 gene, which codes for a receptor on cell surfaces, that gives themnatural immunity to HIV. Upon finding out that Brown was HIV-positive, Htter decided to look for a bone marrow donor who might have this variant. As Htter explained to The Scientist in 2015, he screened dozens of donors until he found one with the so-called delta32 mutation.

Within months of the transplant, the virus was gone from Browns cells, although his recovery was difficult and he required a second transplant to treat the leukemia.

In 2012, Brown and activist Dave Purdy started the Cure for AIDS Coalition to raise awareness of HIV research. According to aFacebook post by Browns partner, Tim Hoeffgen, Tim committed his lifes work to telling his story about his HIV cure and became an ambassador of hope. Tim also gave numerous blood and tissue samples to researchers after his cure.

The invasiveness of the bone marrow transplant precludes it from being applied more widely to HIV patients, but the insights gained from Browns successful cure have inspired further work on CCR5. For instance, in 2017, researchers used CRISPR to disrupt the gene in human hematopoietic stem cells anddemonstrated that these cells could ward off HIV infection in mice transplanted with them. More recently, andcontroversially, the gene was a target of CRISPR-based editing in human embryos to make them resistant to HIV.

Brown never again tested positive for HIV. His leukemia, however, relapsed five months ago.

Timothy was a champion and advocate for keeping an HIV cure on the political and scientific agenda, Sharon Lewin, the director of the Doherty Institute in Melbourne, Australia, tells theBBC. It is the hope of the scientific community that one day we can honour his legacy with a safe, cost-effective and widely accessible strategy to achieve HIV remission and cure using gene editing or techniques that boost immune control.

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Timothy Ray Brown, First Person to Be Cured of HIV, Dies - The Scientist

Cytovia Therapeutics to present at Jefferies Cell Therapy Virtual Summit, BIO Investor Forum and New York Stem Cell Foundation Conference in October…

NEW YORK, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Cytovia Therapeutics an emerging biopharmaceutical company developing Natural Killer Cell Therapeutics, today announced that it will participate in three key conferences in October 2020.

The Jefferies Cell Therapy Virtual Summit will take place on October 5-6, 2020. Cytovia CEO Dr. Daniel Teper will present on October 6th at 5.30 PM EDT. Webcast link

The BIO Investor Forum will take place on October 13-15, 2020. Cytovia will have an on-demand company presentation during the Bio Investor Forum Digital.

The New York Stem Cell Foundation Conference will take place on October 20-21, 2020. Dr. Wei Li, Cytovia Executive Vice President, R&D and Chief Scientific Officer, will present during the Stem Cell Application in Therapeutics session, on October 21st at 11.15 AM EDT.

The webcast links will be available on the company website and social media pages.

On-demand interview opportunities with Cytovia Therapeutics spokespersons: Daniel Teper, CEO Wei Li, Chief Scientific Officer

ABOUT CYTOVIA THERAPEUTICS: Cytovia Therapeutics Inc is an emerging biotechnology company that aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer and severe acute infectious diseases. Cytovia focuses on Natural Killer (NK) cell biology and is leveraging multiple advanced patented technologies, including an induced pluripotent stem cell (iPSC) platform for CAR (Chimeric Antigen Receptors) NK cell therapy, next-generation precision gene-editing to enhance targeting of NK cells, and NK engager multi-functional antibodies. Our initial product portfolio focuses on both hematological malignancies such as multiple myeloma and solid tumors including hepatocellular carcinoma and glioblastoma. The company partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF), the Hebrew University of Jerusalem, and CytoImmune Therapeutics. Learn more at http://www.cytoviatx.com and Follow Cytovia on Social Media Facebook, LinkedIn, Twitter.

For more information please contact: Cytovia Therapeutics, Inc Sophie Badr, Vice President, Corporate Affairs 1 (929) 317 1565 sophie.badre@cytoviatx.com

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Cytovia Therapeutics to present at Jefferies Cell Therapy Virtual Summit, BIO Investor Forum and New York Stem Cell Foundation Conference in October...