Russell Health Honored in Global Business Leaders Magazine’s ’20 Leading Companies of the Year 2021′ – PRNewswire

WILLOWBROOK, Ill., April 14, 2021 /PRNewswire/ --Based in Willowbrook, Illinois, Russell Health is a national marketer and distributor of specialty medical products and services. Russell Health, Inc., was recently awarded as #2 in Global Business Leaders Magazine's "20 Leading Companies of the Year 2021." Based in Atlanta, Georgia, Global Business Leaders Magazine's mission 'focuses on exalting the contribution of leaders who have been the emissary for their respective industries.' Their 2021 Top 20 list features a collection of leaders across industries like medical technology, finance, marketing, blockchain solutions, industrial fabrication, and more. Read more here

Russell Health's full-page feature presents an article titled, "Russell Health: A Mini Amazon for Regenerative Medicine." It discusses the history of Russell Health Inc., ongoing research and benefits of Stem Cell Recruitment Therapy, and well-defined commentary about how Russell Health has redefined the medicine market, even during a global pandemic. Read Russell Health's featured article here

About Russell Health: Russell Health and its partners have distributed regenerative therapy products nationwide and achieved profound clinical outcomes in multiple therapeutic areas including cosmetics, wound care, pain management, podiatry, orthopedic, dentistry and gynecology. With their partners and suppliers, they work to provide innovative life-changing and sustaining products and therapies to patients and healthcare providers around the world.

Russell Health's Stem Cell Recruitment Therapyproducts are intended for homologous use to help repair, reconstruct or supplement the patient's joints or soft tissue as well as help to increase mobility while decreasing pain. These responsibly sourced acellular tissue allografts are helping people of all ages to recover from injuries and get their life back.

Pull Quotes:

"We have built a mini-Amazon for regenerative medicine." (Ryan Salvino, CEO of Russell Health)

"Our ultimate goal from the beginning has been to help people by providing safe alternatives to risky procedures and expensive treatments while offering an alternative to synthetic drugs and embracing more holistic and organic products. We want to continue to become the number one supplier of regenerative medicine in the U.S." (Jonathan Benstent, Vice President of Russell Health)

"While the pandemic caused major disruption throughout the industry, it managed to pivot patients and physicians toward alternative treatments such as Stem Cell Recruitment Therapy. This demand can help in further enhancing the discovery of new applications for Stem Cell Recruitment Therapy products. As a result, Russell Health is working with some of the top leaders in the regenerative medicine field to continue to grow and provide innovative products to customers and their patients." (Global Business Leaders Magazine)

Visit Russell Health online to learn more about Stem Cell Recruitment Therapy. For media inquiries or to contact the Russell Health team directly. Please visit http://www.russellhealth.comor email [emailprotected].

Contact: Veronica Bennett

Address & Phone: 621 Plainfield Rd., Willowbrook, IL 60527; 844-249-6200

Email: [emailprotected]

Online: http://www.russellhealth.com

Social Media: http://www.linkedin.com/company/russell-health:: https://www.facebook.com/russellhealthinc:: https://www.instagram.com/russellhealth:: https://twitter.com/health_russell

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Russell Health Honored in Global Business Leaders Magazine's '20 Leading Companies of the Year 2021' - PRNewswire

Durable B-ALL Control With Allogeneic Transplant After CAR T-Cell Therapy – Cancer Therapy Advisor

Children and young adults who underwent an allogeneic hematopoietic stem cell transplant (alloHSCT) after achieving complete response with CD19 CAR T-cell therapy experienced durable B-cell acute lymphoblastic leukemia (B-ALL) control, according to the results of a phase 1 trial (ClinicalTrials.gov Identifier: NCT01593696) published in the Journal of Clinical Oncology.

Although a proportion of patients who undergo CAR T-cell therapy go on to receive alloHSCT, the study authors stated that The role for [alloHSCT] following CD19-CAR T-cell therapy to improve long-term outcomes in [children and young adults] has not been examined.

The phase 1 trial evaluated 50 children and young adults with B-ALL who received CD19.28 CAR T-cell therapy. The primary objective was to determine the maximum tolerated dose of CAR T cells, toxicity, and feasibility of generating CAR T cells in the study population. In addition, this analysis retrospectively evaluated the effect of alloHSCT on survival after CAR T-cell therapy.

At baseline, the median age was 13.5 years (range, 4.3-30.4), and 40 (80%) of the patients were male. The median number of prior regimens was 4 (range, 4.3-30.4); 22 (44%) patients had at least 1 prior HSCT, 2 (4%) had prior CD19-targeted therapy, and 5 (10%) of the patients had prior treatment with blinatumomab.

Complete response was achieved in 31 (62%) of the patients. Among these patients, 28 (90.3%) were negative for minimal residual disease. Higher rates of complete response were associated with primary refractory disease, fewer prior lines of therapy, M1 marrow, or fludarabine/cytarabine-based lymphodepletion. The median overall survival was 10.5 months (95% CI, 6.3-29.2) during a median follow-up of 4.8 years.

Of the 28 patients who achieved complete response, 21 (75%) proceeded to undergo consolidative alloHSCT. The median overall survival for these patients was 70.2 months (95% CI, 10.4-not estimable), with an event-free survival not yet reached. The rate of relapse after alloHSCT was 4.8% (95% CI, 0.3-20.3) at 12 months and 9.5% (95% CI, 1.5-26.8) at 24 months.

Any grade cytokine release syndrome (CRS) developed among 35 (70%) patients, with 9 (18%) experiencing grade 3 to 4 CRS. Of the 10 patients (20%) who developed neurotoxicity, 4 cases were severe. One cardiac arrest occurred during CRS. All patients with CRS, neurotoxicity, and cardiac arrest recovered.

The authors concluded that CD19.28 CAR T cells followed by a consolidative alloHSCT can provide long-term durable disease control in [children and young adults] with relapsed or refractory B-ALL.

Disclosure: Please see the original reference for a full disclosure of authors affiliations.

Reference

Shah NN, Lee DW, Yates B, et al. Long-term follow-up of CD19-CAR T-cell therapy in children and young adults with B-ALL. J Clin Oncol. Published online March 25, 2021. doi:org/10.1200/JCO.20.02262c

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CRISPR lauds easy scale-out of cell therapy – BioProcess Insider – BioProcess Insider

The autologous nature of its gene-edited stem cell candidate CTX001 means scaling manufacturing from clinical to commercial will be relatively easy, says CRISPR Therapeutics.

Codeveloped with Vertex Pharmaceuticals, CRISPR Therapeutics CTX001 is an autologous CRISPR/Cas9 gene-edited hematopoietic stem cell therapy targeting patients suffering from -thalassemia and sickle cell disease.

Production of the candidate involves collecting a patients own blood stem cells via mobilization and apheresis and editing them with CRISPR/Cas9 to increase fetal hemoglobin (HbF) expression. When the edited cells are returned to the patient, they are expected to generate red blood cells that have increased levels of HbF, which may reduce or eliminate patients symptoms.

Image: iStock/zest_marina

The firm recently presented positive Phase I/II data for the autologous candidate and now has an eye on scaling-up production as it progresses through the clinic.

We dont believe we will need to make any major modifications to the manufacturing process that we started with, to take it into commercialization, and thats a huge benefit, Lawrence Klein, CRISPRs COO said at the 20th Annual Needham Virtual Healthcare Conference this week. And thats just by virtue of the fact that our initial manufacturing process led to the type of efficacy that we saw, and we purpose built that process to enable commercial scale.

Therefore, to increase production the firm needs to add more suites: scaling-out, rather then scaling-up.

You can basically just clone those suites, and the more suites you have the more throughput you have, he told delegates. Its not like if youre moving from a 10-liter reactor to a 10,000-liter reactor [when] things change in terms of the biochemistry of the process.

To augment production adding people and facility and instrumentation the firm uses undisclosed contract manufacturing organizations (CMO).

When we started the trial, we had one, said Klein. Weve added CMOs since that point, different facilities and we intend to continue doing that to enable broader scale in different geographies.

The CMOs that weve chosen, theyre scalable. And you can see the major CMOs are making heavy investments in this space of gene and cell therapy. And so, we think well be able to scale that capacity as we move forward into commercialization.

CRISPR Therapeutics is also building a cell therapy manufacturing facility in Framingham, Massachusetts being designed to provide GMP manufacturing in compliance with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations and guidelines.

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NeoProgen, Inc. Receives First Granted Patent for Method to Treat Cardiac Conditions using Neonatal Heart-derived Medicinal Signaling Cells (nMSCs)…

BALTIMORE--(BUSINESS WIRE)-- NeoProgen, Inc., a pre-clinical stage company developing an exosome-based product from human neonatal heart-derived Medicinal Signaling Cells (nMSCs) for tissue repair and regeneration for the treatment of heart failure (HF) and other inflammatory diseases, announced that it has received a patent from the United States Patent Office Patent No.: US 10.967,007 B2 Cardiac Stem Cells for Cardiac Repair. The innovation was developed by Dr. Sunjay Kaushal, a pediatric cardiac surgeon, while he was at the University of Maryland, Baltimore and NeoProgen is the exclusive licensee of the newly issued patent.

The patent claims describe methods for treating cardiac conditions with an exosome-based therapy (conditioned media) derived from neonatal cardiac stem cells. The unique approach that the company has taken to isolating the cells, culturing nMSCs, characterizing them by their secretome and exosome production, and improving cardiac function by administering allogeneic nMSCs to adults and children represents an exciting therapy for heart failure and other inflammatory diseases.

As a Cardiovascular-Thoracic surgeon, my goal is to help patients by performing heart transplantations and heart surgeries, in many cases to newborn babies that need these procedures to correct life-threatening congenital problems. For many years I have had the opportunity to study stem cells that are present in the very young heart to treat chronic diseases seen in adults, having been involved as a Principal Investigator in multiple stem cell trials. Comparative studies analyzing multiple stem cell types support the notion that nMSCs and their secretomes/exosomes derived from neonatal heart tissue covered under this patent are the most regenerative stem cell type discovered, said Dr. Sunjay Kaushal, MD, PhD, Division Head Cardiovascular Thoracic Surgery at Ann & Robert H. Lurie Childrens Hospital of Chicago and founder of NeoProgen. Dr. Kaushal explained, Stem cell ingredients are key to their success in clinical trials. nMSCs are very special cells with a great regenerative potential and prolific abilities. The innate abilities of secretomes/exosomes from these cells set us apart from other stem cell types used in clinical trials. Its my hope that in the future pediatric and adult patients will not only benefit from the surgeries but also by stem cell therapies like this one to improve their outcomes and quality of life.

This is a major milestone for NeoProgen, said Bill Niland, the companys CEO who has successfully founded and exited three previous healthcare companies. In addition to expanding our patent portfolio, this patent gives us coverage of our #1 asset: a secretome/exosome product that we expect to get into a phase 1 trial this year for Ischemic Cardiomyopathy, where we have excellent pre-clinical results.

The company has engaged BioPharma Capital to exclusively represent them in actively raising capital and in discussions with potential strategic partners. Dan Ross, Managing Partner of BioPharma Capital added, NeoProgen stands out amongst its peers as harnessing a uniquely potent source for stem cells that, along with this newly issued patent, addresses both of the challenges that have historically beleaguered the stem cell therapy space and continue to do so today: manufacturing/supply and IP. We are pleased to be working with NeoProgen and look forward to doing our small part in helping this promising treatment make its way towards helping patients around the world.

About NeoProgen:

NeoProgen, Inc., is a pre-clinical stage company developing human neonatal heart-derived Medicinal Signaling Cells (nMSCs) and an exosome-based product for tissue repair and regeneration for the treatment of heart failure (HF) and other inflammatory diseases.

About BioPharma Capital:

BioPharma Capital, LLC provides life sciences focused investment banking services, including M&A Advisory, strategic partnering and financing transaction management. We are dedicated to maximizing value for our clients using credible scientific and evidence driven approaches. Our clients are typically pharmaceutical and biotech companies considering partnering, out-licensing, divestitures, fund raising or corporate sales. Our team provides decades of experience in transaction support, healthcare strategy consulting, pricing and market access, forecasting, investment banking and translational research. We understand the science and technology behind the assets we represent and we have vast expertise managing transactions. Securities and Investment Banking Services are offered through Ashland Securities, LLC. Supervised by the Home Office, located at 80 S.W. 8th Street, Suite 2000 Miami, Florida 33130. Phone Number 305-279-3176. Member FINRA SIPC. Please refer to BrokerCheck for more information about Ashland Securities, LLC. BioPharma Capital, LLC and Ashland Securities, LLC are separate and unaffiliated entities.

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CRISPR gene therapy for sickle cell disease approved by the FDA – BioNews

12 April 2021

A clinical trial for a new gene therapy approach to treat sickle cell disease has been approved to proceed by the US Food and Drug Administration.

Patients with sickle cell disease have a mutation in the beta-haemoglobin gene, causing them to produce misshapen red blood cells that can block blood vessels leading to severe pain, anaemia and potentially life-threatening complications, such as organ damage and strokes.Currently, the only cureis a stem cell transplant from a healthy donor, but in the newly-approved trial, scientists from the University of California will use CRISPR/Cas9 genome editing to replace the faulty gene with a functional version.

'Gene therapy and genome editing allow each patient to serve as their own stem cell donor,' said Professor Donald Kohn, from the Broad Stem Cell Research Centre at the University of California Los Angeles, one of the clinical trial leaders. 'In theory, these approaches should be much safer than a transplant from another person and could become universally available because they eliminate the need to find the needle in a haystack that is a matched stem cell donor.'

In the trial, blood stem cells will be harvested from the patients and grown in the lab. CRISPR/Cas9 will be used to 'cut and replace' a sequence of DNA containing the mutation with a healthy copy. The edited cells will then be returned to the patient's body in the same way they would be if the patient was receiving donor stem cells.

'The goal of this form of genome editing therapy is to correct the mutation in enough stem cells so the resulting blood in circulation has corrected red blood cells,' said Dr Mark Walters, from the University of California San Francisco Benioff Children's Hospital, another of the clinical trial leaders.

The study will take place over four years, and include six adults and three adolescents with severe sickle cell disease, testing both safety and efficacy.

The treatment does have risks: the patientswill need to have high dose chemotherapy, to kill allremaining bloodstem cells before the modified stem cells are put back. This is also necessary before receiving donor stem cells and can cause severe side effects as the patient's immune system is temporarily disabled.

A similar trial, using CRISPR/Cas9 to activate bone marrow stem cells to produce an alternative version of haemoglobin, rather than correcting the faulty version, has recently shown promising results in a patient with sickle cell disease (see BioNews 1052).

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CRISPR gene therapy for sickle cell disease approved by the FDA - BioNews

Man’s heart healed by stem cell therapy and love of an old flame – Leeds Live

A Wakefield man has shared the story of how his broken heart was fixed following a chance encounter with an old flame who was looking after him in hospital.

Fitness fanatic Barry Newmans heart was working at just 13% capacity and had him fearing for his life before fate stepped in with a revolutionary medical procedure and an old girlfriend.

At one point Barry was a shell of his former self and a heart transplant looked like the only viable solution.

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But after coming across a new procedure on The One Show he underwent surgery at a private clinic and his heart is now operating at double its former capacity, with one doctor saying he was a "walking miracle".

By chance, one of the people caring for Barry at Leeds General Infirmary was cardiac physiotherapist Nicki Simpson an old flame from their clubbing days in the 1980s.

Their love was quickly reignited and Barry soon popped the question, though it did result in a moment of awkwardness.

When he declared he had something to announce, Nicki feared he had yet more bad news about his health.

But then plasterer Barry smiled and, from behind his back, pulled out a ring with a large diamond in it.

Speaking to The Mirror, Mr Newman said: Nicki had been my cardiac physio since just after I was first diagnosed with my heart condition, so she knew better than anyone what shed be committing to if she said yes.

But within an instant she gave me a massive hug and kiss and said shed love to be my wife.

With Mr Newman's heart failure, the couple feared they might be on borrowed time.

But Barry, 54, would have another lucky break after chancing upon a revolutionary stem cell procedure that has already doubled his hearts capacity to 26% of normal function.

And that means he and Nicki can think about setting a wedding date next year.

Their remarkable love story goes back to their teenage days. Though they eventually drifted apart, an unlikely reunion came after Barry fell ill in late 2013.

After years priding himself on his healthy lifestyle, he began feeling short of breath, to the point of falling to his knees.

He was prescribed antibiotics but the problem persisted. In February 2014 a CT scan showed he had a massive, dilated heart and critical condition cardiomyopathy.

Doctors said it had likely been caused by a virus and his heart was working at a fraction of its usual capacity.

Barry said: I was told the only real solution was a heart transplant.

I was transferred to Leeds General Infirmary for what was basically palliative care to keep me alive as long as possible.

Compared to just a year before, I felt like my body was broken, all my strength was gone and I feared Id not see my son Robert graduate.

Barry had ongoing care from a cardiac nurse and, towards the end of 2014, was told he would also have the support of a cardiac physiotherapist.

He says: I was amazed when that person turned out to be Nicki, an old girlfriend from our clubbing days in the 1980s.

Wed been an item when we were 19. We drifted apart and I hadnt seen her since.

As soon as the pair clapped eyes on one another, their old spark was back even with Barry so terribly unwell.

We hit it off straight away, laughing at all the old memories, he says. In no time we were a couple again, almost three decades later.

Of course she knew this was a rather precarious situation for me as well as us as a couple.

But that didnt bother her one bit.

With professional and emotional support from Nicki, 54, Barry had a defibrillator fitted in his chest in 2016 which would restart his heart if it ever lost rhythm.

He has remained realistic throughout and says: I knew this was just another strategy to keep me alive until I reached crisis point and could be put on the transplant list.

I got progressively worse, to the point where every time I ate anything Id go grey and collapse and would have to be rushed to A&E.

This happened so many times I got to know all the nurses and porters at the hospital by first name.

Then in October 2017, Barry and his son saw a jaw-dropping report about work by the Heart Cells Foundation charity on TVs The One Show that would change the course of his life.

The innovative procedure involved taking bone marrow from the patients pelvis, harvesting stem cells, then injecting them straight into the heart.

With his "heart nearing its end", Barry instantly got his son Robert to contact the charity and its lead clinician, Professor Anthony Mathur.

Barry said: It seemed such a quick and painless procedure."

The foundation treats patients who are at the end-stage of life, and in November 2018 Barry underwent week-long treatment in London.

After a series of injections to stimulate the bone marrow, the procedure was carried out on the last day.

Barry said he was staggered by its apparent simplicity and how a routine op two months later showed how it was already working.

He says: It couldnt have been less painful.

I was booked in for a small operation in January 2019 and the anaesthetist said because of my heart he was hesitant about putting me under. I did a treadmill test to see how strong my heart was and the doctor said I was a walking miracle my results didnt match with my records.

Barry says he has since gone from strength to strength. He adds: While some cardiologists Ive spoken to are still cynical about my stem cell procedure, the facts speak for themselves.

My heart is now at 26% capacity, Im not taking all the various meds I was prescribed before, I can exercise properly, and feel amazing.

Before my procedure one of my worst fears was my amazing dad would have to go to my funeral, something no parent should ever have to do.

Sadly, I lost him in 2020 after a cancer battle, but I was so grateful he didnt have to watch me reach the end, to bury his own son. I also got to see Robert, 25, graduate in aeronautical engineering from Sheffield University, going on to work for a Formula 1 team and Nicki and I are planning our wedding next year.

This miraculous stem cell treatment hasnt just saved my life, its given me and my family a future, which is priceless.

Barry is among nearly 400 Brits who have received the treatment in its early phase and the success rate is 80%.

Patients typically experience improved heart function and a better quality of life with no further use of medication. Now doctors hope it could change the lives of countless more people. The procedure costs up to 10,000 a go and is not currently available on the NHS.

Learn more at heartcellsfoundation.com

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Autologous Stem Cell Based Therapies Market Professional Report 2021 Witness Robust Expansion by 2026 SoccerNurds – SoccerNurds

Global Autologous Stem Cell Based Therapies Market offers a complete analysis which includes market size, share, overview, and growth prospects that are impacting the growth of the Autologous Stem Cell Based Therapies Industry. Global Autologous Stem Cell Based Therapies market report offers consumers to recognize the market challenges and opportunities. This report provides the latest information about the technological developments and market growth prospect based on the regional landscape.

This Autologous Stem Cell Based Therapies market report provides a recent novel COVID-19 pandemic, the Post impact of the COVID-19 pandemic on the global Autologous Stem Cell Based Therapies market. The influence of the novel coronavirus pandemic on the growth of the Autologous Stem Cell Based Therapies market is analyzed and depicted in the report.

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The report also focuses on the global major leading industry players of the Global Autologous Stem Cell Based Therapies market providing information such as company profiles, product picture, and specification, capacity, production, price, cost, revenue, and contact information.

Major Players Covered in Autologous Stem Cell Based Therapies Market Report are:

Based on product, this report displays the production, revenue, price, market share and growth rate of each type, primarily split into:

Based on the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including:

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast of the following regions are:

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The Autologous Stem Cell Based Therapies Market development trends and marketing channels are analyzed. Finally, the feasibility of new investment projects is assessed, and overall research conclusions offered.

The Research Provides Answers to The Following Key Questions:

1) Detailed information about Key Top Competitors in the Global Autologous Stem Cell Based Therapies Market?

2) What is the expected market size and growth rate of the Autologous Stem Cell Based Therapies market for the period 2020-2026?

3) Which Are the Main Key Regions Cover in Reports?

4) Can I include additional segmentation/market segmentation?

Major Points in Table of Content of Autologous Stem Cell Based Therapies Market

PART 01: EXECUTIVE SUMMARY

PART 02: SCOPE OF THE REPORT

PART 03: Autologous Stem Cell Based Therapies MARKET LANDSCAPE

PART 04: Autologous Stem Cell Based Therapies MARKET SIZING

PART 05: FIVE FORCES ANALYSIS

PART 06: Autologous Stem Cell Based Therapies MARKET SEGMENTATION BY PRODUCT TYPE

PART 07: CUSTOMER LANDSCAPE

PART 08: GEOGRAPHIC LANDSCAPE

PART 09: DECISION FRAMEWORK

PART 10: DRIVERS AND CHALLENGES

PART 11: Autologous Stem Cell Based Therapies MARKET TRENDS

PART 12: COMPETITIVE LANDSCAPE

PART 13: COMPETITIVE ANALYSIS

PART 14: APPENDIX

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Mastitis therapy explored | AG | kmaland.com – KMAland

Apart from antibiotics dairy farmers have few tools to treat mastitis. So researchers at Cornell Universitys College of Veterinary Medicine, are exploring compounds secreted by stem cells as a potential therapy.

The researchers previously investigated the beneficial effects of the bovine mammary stem-cell secretome. The secretome is comprised of all the compounds secreted from laboratory-grown bovine mammary stem cells. Preliminary work showed the secretome had antimicrobial properties. It prevented damage from bacterial toxins and promoted healing through the growth of blood vessels and recruitment of new cells.

Now with help from Elanco, Dr. Gerlinde Van de Walle, a veterinarian and associate professor of microbiology and immunology, and Dr. Daryl Nydam, faculty director of the department of population medicine and diagnostic services, will perform similar experiments with the secretome in actual cows. Theyre treating mastitis-infected cows using different components of the secretome to pinpoint which compounds are responsible for its beneficial effects.

Theyre looking for any antimicrobial effects, differences in milk production, signs of healing, and regeneration of the mammary tissue. They also are watching for changes in the bovine immune system that may help fight the infection and comparing the effects of different types of bovine stem cells.

The long-term goal would be a natural product that could be an adjunct or even a replacement for antibiotics, Van de Walle said.

The Foundation for Food & Agriculture Research awarded a $642,000 research grant to the Cornell researchers. If the treatment is effective and affordable, it has potential for adoption nationwide, resulting in enhanced milk production and farmer profitability, said Sally Rockey, the foundations executive director.

Elanco and the New York Farm Viability Institute contributed matching funds for a $1.4 million total investment. Addressing concerns about the increase in antibiotic-resistant bacteria, Elanco aims to provide farmers alternatives to the use of medically important antibiotics.

The research also has potential applications beyond mastitis, Van de Walle said.

If we find that naturally secreted biomolecules can both replace antibiotics and restore damaged tissue, this work could be expanded to other livestock and other diseases, she said.

Visit vet.cornell.eduand foundationfar.org and nyfvi.org for more information.

At KMA, we attempt to be accurate in our reporting. If you see a typo or mistake in a story, please contact us by emailing kmaradio@kmaland.com.

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Stem Cell Therapy Market Analysis 2021: Size, Share, Sales, Growth, Revenue, Type, Application & Forecast To 2027 SoccerNurds – SoccerNurds

Stem Cell TherapyMarket Size 2021 Industry Share, Strategies, Growth Analysis, Regional Demand, Revenue, Key Players and 2027 Forecast Research Report

The report envelops a few factors that have added to the development of the market lately. It features a couple of the main market drivers and investigations their effect available. Among all factors, the expanding number of organization consolidations and joint efforts decidedly affect market development. With this procurement, the organization will hope to beat its partners and in doing as such, set up a solid presence on the lookout. The report features a couple of the other organization consolidations that have graced the market as of late and measures their effect available.

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Top Key Players in this Market Research Report

Pharmicell Co., Ltd Holostem Terapie Avanzate S.r.l. Osiris Therapeutics, Inc. MEDIPOST Co., Ltd. Nuvasive, Inc. Celgene Corporation Anterogen Co., Ltd. Promethera Biosciences Fibrocell Science, Inc. RTI Surgical, Inc. RTI Surgical, Inc Cytori Therapeutics

By Types

Adult Stem Cells Human Embryonic Induced Pluripotent Stem Cells Very Small Embryonic Like Stem Cells

By Applications

Regenerative Medicine Drug Discovery and Development

Global Stem Cell Therapy Market is further classified on the basis of region as follows:

Some Point from Table of Content:

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An Overview of the Impact of COVID-19 on Stem Cell Therapy Market:The emergence of COVID-19 has brought the world to a standstill. We understand that this health crisis has brought an unprecedented impact on businesses across industries. However, this too shall pass. Rising support from governments and several companies can help in the fight against this highly contagious disease. There are some industries that are struggling and some are thriving. Overall, almost every sector is anticipated to be impacted by the pandemic. We are taking continuous efforts to help your business sustain and grow during COVID-19 pandemics. Based on our experience and expertise, we will offer you an impact analysis of coronavirus outbreak across industries to help you prepare for the future.

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CAR T-Cell Therapy Enters the Arena in Multiple Myeloma With Ongoing Research Ahead – OncLive

The FDA approval of idecabtagene vicleucel (ide-cel; Abecma) has established a role for CAR T-cell therapy in heavily pretreated, relapsed/refractory multiple myeloma, with the product showing an unprecedented response rate and a generally favorable safety profile, said Saad Z. Usmani, MD, FACP.

However, with additional BCMA-directed constructs, allogeneic CAR T-cell products, and bispecific antibodies in the pipeline, ide-cel could become just 1 of many novel options the field.

BCMA-directed CAR T-cell therapy has good activity in heavily pretreated patients with multiple myeloma, including patients with triple-class refractory disease, said Usmani. Cytokine release syndrome [CRS], neurotoxicity, and low blood counts are [common], but patients [typically] recover from these adverse effects [AEs]. The timing of CRS and neurotoxicity could be different [between products], but we are seeing good activity [overall].

On March 26, 2021, the FDA approved ide-cel as the first BCMA-directed CAR T-cell therapy for patients with relapsed/refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.1

The regulatory decision was based on data from the phase 2 KarMMA trial, in which ide-cel elicited an overall response rate (ORR) of 72% and a stringent complete response (sCR) rate of 28% in patients with relapsed/refractory myeloma who had received at least 4 prior treatments.2

Another CAR T-cell product, ciltacabtagene autoleucel (cilta-cel) is currently in the myeloma pipeline, having demonstrated an ORR of 96.9% and an sCR rate of 67.0% in the phase 1b/2 CARTITUDE-1 trial.3 Notably, the median time to onset of CRS was 1 day with ide-cel compared with 7 days with cilta-cel.2,3 In April 2021, Legend Biotech, the developer of cilta-cel, announced that a rolling submission of a biologics license application to support the approval of the drug for the treatment of patients with relapsed/refractory multiple myeloma has been completed.4

In an interview with OncLive during an Institutional Perspectives in Cancer webinar on CAR T-cell therapy, Usmani, chief of Plasma Cell Disorders and director of Clinical Research in Hematologic Malignancies at the Levine Cancer Institute of Atrium Health, discussed the rapidly changing cellular therapy paradigm in relapsed/refractory multiple myeloma.

Usmani: Ide-cel is a BCMA-directed CAR T-cell therapy that is the furthest along in terms of clinical development; we have the most follow-up with that particular construct. The key takeaway from the data [from the KarMMA trial], which were shared during the 2020 ASH Annual Meeting and Exposition, was that the initial signal of efficacy in the dose-escalation study did play out in the subsequent dose-expansion cohort. Longer-term follow-up [data have shown that] patients are getting minimal residual diseasenegative complete responses; some patients who have been off of treatment are showing sustained remissions at 2 years and beyond.

There doesnt appear to be any long-term safety concerns so far with [ide-cel]. The CRS and neurotoxicity that is seen is short term [and occurs] during the early parts of treatment, usually within the first month or so.

Importantly, an analysis [showed that]patients with high-risk cytogenetics [or] extramedullary multiple myeloma tended to have the same disease response with ORRs around 70% or higher.

KarMMA-2 [NCT03601078] has several different cohorts, including patients who are receiving ide-cel in earlier lines of treatment, patients who are receiving ide-cel with prior exposure to BCMA-directed therapy, and patients [who are receiving ide-cel] with high-risk disease, which will serve as a safety signalgenerating cohort.

[The KarMMA-2 trial] led to the development of the KarMMA-4 trial [NCT04196491], which is a frontline study for high-risk patients post induction.

The KarMMA-3 trial [NCT03651128] is another ongoing trial comparing ide-cel with standard triplet regimens in relapsed/refractory multiple myeloma. Some ide-cel studies [within] the Cooperative Group Setting were in the [Blood and Marrow Transplant Clinical Trials Network] looking at ide-cel after autologous stem cell transplant in high-risk patients [with multiple myeloma].

The next endeavor that we are going to have as we are thinking about CARrelated products is how quickly we can give these therapies. Currently, it takes between 4 to 6 weeks from the time that we think about giving a patient CAR T-cell therapy to getting them on a trial, to [them undergoing] apheresis, and finally, getting the product back. Logistically, this can take up to 2 months on clinical trials. It would be ideal to have an off-the-shelf option, which is where the ALLO-715 concept is very important.

If we have an allogeneic product from a single donor, we can make 100 off-the-shelf products ready to go. If I need to give such a product to a patient, I can start lymphodepleting chemotherapy and give them CAR T-cell therapy [shortly thereafter].

ALLO-715 tried to do that and is being evaluated in a dose-escalation, early-phase study. The important thing [about ALLO-715] is that about 90% of patients were treated within 5 days of enrolling, which is a much shorter timeframe [compared with autologous CAR T-cell therapy]. Moreover, there appears to be clinical activity [with ALLO-715] at the highest [dose] of 320 million [cells]. Six out of 10 patients had a response with 4 out of 10 having a very good partial response or better. [The trial has] short follow-up in a small cohort of patients, but the data are encouraging.

The early approvals will come in the relapsed/refractory setting for patients who have had exposure or refractoriness to PIs, IMIDs, and [monoclonal] antibodies. Most of our early usage once [CAR T-cell therapies] come to the clinic will be for those patients, and part of their usage will be dependent on how much capacity each transplant and cellular therapy center has. Having said that, we are probably going to have a little bit more flexibility in how we can bridge patients to CAR T-cell therapy. Getting patients to CAR T-cell therapy would be ideal, so we will try to do that for most patients. However, bispecific antibodies are also coming down the pike, so those will be good backup options too.

The second most mature dataset we have is with cilta-cel from the CARTITUDE-1 trial, [showing] a very impressive 97% ORR. With [cilta-cel], the time to CRS onset and neurotoxicity events is a bit delayed compared with ide-cel. As we think operationally, if both products [become] available to us, maybe one [product could be] given in the outpatient setting vs monitoring patients in the inpatient setting early on. Every center will look at things in a little bit of a different way based on their resources, but it is a good problem to have more than 2 options for patients.

We also have the bb21217 construct, which has the same construct as ide-cel. However, a PI3K inhibitor is utilized during the CAR T-cell expansion to push it toward more of a memory T-cell phenotype, [which could translate] to long-term remission for patients.

Then we have the LUMMICAR constructs, which are somewhat similar in terms of data and safety to ide-cel with lower-grade CRS. [With the investigational] PRIME-BCMA-101 [product], the CAR T cells do their job and then are out of the system quickly. There too, we are seeing low rates of CRS overall, as well as low [rates of] grade 3 or 4 CRS.

The efficacy and safety, as well as the vein-to-vein time, appear to be the keys [to getting CAR T-cell therapy into the clinic], but it is early. Im curious to see how all of this evolves, especially with ide-cel and cilta-cel as frontrunners.

The advantages in favor of CAR T-cell therapies are that although its more labor intensive early on, they dont require maintenance. Patients do enjoy that quality of life after having recovered from CAR T-cell therapy.

The disadvantages [include] production time and capacity of transplant centers, which play a role in discussing what may be the best option for patients. With the bispecific antibodies coming along, it is highly likely that we could see usage of antibody-drug conjugates and bispecific antibodies in the community setting even before patients come to see us for a CAR T-cell therapy consultation. There are a lot of nuances [to utilizing these products] that we will have to figure out once we have the therapies [available].

[Ultimately], the one-and-done approach that CAR T-cell therapy [provides] is quite unique and many patients will favor that.

Editors Note: This interview took place prior to the March 26, 2021, FDA approval of idecabtagene vicleucel in relapsed/refractory multiple myeloma.

Continued here:
CAR T-Cell Therapy Enters the Arena in Multiple Myeloma With Ongoing Research Ahead - OncLive