Stem Cell Clinic

ANDREWS MEDICINE AND CELLTEX THERAPEUTICS CORPORATION JOIN FORCES TO BRING CUTTING EDGE TECHNOLOGIES TO ATHLETIC INJURIES – PR Newswire

By Stem Cell Medicine

HOUSTON, Oct. 4, 2022 /PRNewswire/ -- James R. "Jim" Andrews, MD, Chairman and CEO of Andrews Medicine of Pensacola, Florida, and David G. Eller, Chairman and CEO of Celltex Therapeutics Corporation of Houston, Texas, announced today that together they will form a new biotechnology company to bridge the divide between stem cell research and the current treatment of athletic injuries. The jointly owned company will operate under the name of "Andrews Celltex Biologics".

The new company will undertake the operation of a Sports Injury Program that includes the Celltex-sponsored FDA developmental study associated with its Investigational New Drug (IND) for the use of Celltex-produced autologous Mesenchymal Stem Cells (MSCs) in the treatment of orthopedic indications. Andrews Medicine will participate in this FDA observed IND research study and will be responsible for selection of participants and administration for this new study. The new venture promises to bring the best medical orthopedic practices of Andrews Medicine for treatment of sports injuries with best practices of Celltex for production of therapeutic quality autologous MSCsas a regenerative component of the treatment. Andrews Celltex Biologics will break new ground with this combined effort. The goal is an FDA approved Biologic License for this Celltex product.

Dr. Andrews said: "I have always known that stem cells, when properly handled, can add value to already effective treatments of inflammatory conditions caused by injury or disease. I am delighted that the FDA has been working with Celltex for studying the safety and efficacy of this combination of Celltex-produced MSCs with traditional medical treatment of multiple sports injury indications. Our know-how and network of sports teams and physicians will add immediate value to our new joint company. I am convinced that Andrews Celltex Biologics will be a leader in this huge growth sector of health care coupled with regenerative medicine."

"Celltex is excited about the opportunity to join forces with one of the best orthopedic and sports medicine companies in the country," said David G. Eller, Chairman and CEO of Celltex. "It is a perfect match. Surgical treatments coupled with Celltex-produced regenerative MSCs will improve recovery time and remediation. This joint effort of the two leading companies in their field will bring cutting edge regenerative health care for sports injuries and beyond."

David Eller continued, "Over the past 11 years, Celltex has developed unique know-how and proprietary technology to produce, in its specially designed cGMP lab, millions of MSCs from a small extraction of a person's adipose tissue. The integrity and vibrancy of the MSCs are of therapeutic quality. Over one trillion MSCs have been produced by Celltex, in its cGMP lab, from individuals wanting their own stem cells reintroduced into their bodies by medical doctors to fight a variety of diseases, especially those caused by inflammatory conditions. Given the autologous nature of Celltex-produced stem cells, there have been no severe adverse events when these stem cells have been reintroduced into the individuals from whom the small, one-time adipose tissue sample had been extracted."

ABOUT ANDREWS MEDICINE OF PENSACOLA, FLORIDA

Andrews Medicine is an integrated healthcare platform built on five decades of research, innovation, and clinical expertise led by internationally recognized orthopaedic surgeon, Dr. James "Jim" Andrews. Widely known as the surgeon for elite athletes from around the world, Dr. Andrews is also a pioneering thought leader in the field of research, injury prevention, new surgical techniques, and practice management. Andrews Medicine brings this experience and expertise to healthcare systems, medical providers, sports organizations, and the communities they serve, ensuring that every patient has access to exceptional clinical care. Read more at: http://www.andrewsmedicine.com

ABOUT CELLTEX THERAPEUTICS CORPORATION

Founded in 2011, Celltex Therapeutics Corporation is a Houston, Texas-based biotechnology company that specializes in the manufacturing and cryopreservation of Mesenchymal Stem Cells (MSCs).Celltex is a leading commercial provider of autologous MSCs for therapeutic use. The Company uses its proprietary technology to isolate, cryopreserve and culture billions of undifferentiated and genetically stable MSCs in its state-of-the-art current Good Manufacturing Practices (cGMP)-compliant laboratory.The Company is dedicated to pioneering technological breakthroughs in regenerative medicine. For more information see: http://www.celltexbank.com

SOURCE Celltex Therapeutics Corporation

Originally posted here:
ANDREWS MEDICINE AND CELLTEX THERAPEUTICS CORPORATION JOIN FORCES TO BRING CUTTING EDGE TECHNOLOGIES TO ATHLETIC INJURIES - PR Newswire

Regenerative Medicine For Heart Diseases: How It Is Better Than Conventional Treatments | TheHealthSite.co – TheHealthSite

By Stem Cell Medicine

The future possibilities of regenerative Medicine are endless. Know how regenerative medicine for heart diseases is better than conventional treatments.

Written by Longjam Dineshwori | Updated : October 5, 2022 9:52 AM IST

In the past few days, news of people dying due to cardiac arrest and heart attack during the festivities have been making headlines. Concerningly, increasing number of younger people, precisely adults who are in their 30s, are getting heart problems today. Health experts have been advising people to maintain a healthy lifestyle to prevent heart diseases or at least delay their onset. Also, tremendous advancements have been made in the field of cardiology making treatment of heart ailments more effective and less invasive. One of them is regenerative medicine, which is now being explored for the treatment of several diseases.

Get to more about regenerative medicine and its possibilities for treating heart diseases from Dr Pradeep Mahajan, Regenerative Medicine Researcher, Stem Rx Bioscience Solutions Pvt. Ltd, Navi Mumbai.

An alarming one out of four deaths in our country today is due to heart disease. This is largely due to our sedentary lifestyles, unhealthy eating habits, and stress. Barring the heart conditions that are present from birth (congenital) or that are passed down through the generations (inherited), heart diseases can be prevented or at least the onset can be delayed by maintaining a healthy lifestyle.

The field of cardiology (relating to the heart) has advanced tremendously, and there are several medications and surgical procedures that help patients maintain the functions of the heart. However, these call for invasive treatments and the need for life-long medications. Moreover, the side effects of medicines should also be taken into account.

Enter the field of Regenerative Cardiology! As the word suggests, this branch refers to utilising the natural healing potential of the body to repair and re-grow damaged heart tissues. Stem cells have been researched in several heart diseases to overcome the damage to the heart and facilitate healing. Not just stem cells, but cell-based products like exosomes, molecular chaperones, growth factors etc. have shown promise as well. Do not think about the technicalities, all these molecules are present in our body and researchers and clinicians are now working on how to apply these for the treatment of several diseases.

Commonly, we hear of blocks in the heart, infection, and weak muscles of the heart that do not pump blood properly leading to various diseases. With cell-based therapies, we can tackle each of these issues. Stem cells (the most basic 'unspecialized' cells of our body) can multiply and form various cells of the body, including heart cells. Similarly, cell products like exosomes are cargo packets they carry the required substances for repair and re-growth of tissues. These biological molecules have 'housekeeping functions, meaning that they ensure that any unwanted product and even bacteria/viruses are removed periodically from the body.

The possibilities of Regenerative Medicine for heart diseases are many blocks in the heart can be dissolved, blood supply can be improved, heart muscles can be strengthened, etc. because these biological molecules are capable of reducing inflammation (swelling) in the body, modify the immune system to function better, enhance the functions of other cells, etc. Since these are part of our own body, providing these molecules in the appropriate quantity at the desired site will enhance healing without side effects. In fact, there is ongoing research on growing healthy heart tissue in labs with these biological molecules to transplant them into the human body. Who knows, someday the whole heart might be grown in a lab! While the future possibilities are endless, the current cell-based therapies can be a definitive addition to enhance the outcomes of existing conventional treatments. Of course, rehabilitation and lifestyle modifications are mandatory to maintain the results.

A holistic approach is important one cannot simply rely on symptom management the core issues have to be targeted and Regenerative Medicine can do just that. The death rate due to heart disease can be reduced and patients will be able to have a better quality of life.

Follow us on

More:
Regenerative Medicine For Heart Diseases: How It Is Better Than Conventional Treatments | TheHealthSite.co - TheHealthSite

Second-Line BCL Treatment Landscape Shifts From ASCT to CAR T-Cell Therapy – Targeted Oncology

By Stem Cell Medicine

Hematologic malignancies have been impacted heavily by the introduction of chimeric antigen receptor (CAR) T-cell therapy, which has demonstrated long remission in major clinical trials and received approvals by the FDA. CAR T-cell therapy provides a new option for patients with relapsed/refractory B-cell lymphoma (BCL).

The current treatment landscape for patients with relapsed/refractory [BCL] looks extremely promising, thanks to the positive results from clinical trials and thus the subsequent FDA approvals of these therapeutics, Manali Kamdar, MD, associate professor of medicine-hematology and clinical director of lymphoma services at the University of Colorado Medicine in Aurora, said in an interview with the SOHO Daily News beforethe 10th Annual Meeting of the Society of Hematologic Oncology (SOHO 2022).

Kamdars presentation on September 30, 2022, at 1:40 pm during the conference concerns the question of when to use CAR T-cell therapy vs autologous stem cell transplant (ASCT) in patients with relapsed/refractory aggressive BCL. She says the 3 phase 3 studies of CAR T-cell products that were presented at the 2021 American Society of Hematology Annual Meeting and Exposition (ASH 2021) have made a major difference in answering this question for high-risk patients.

Patients with diffuse large BCL who relapse within 12 months of frontline chemoimmunotherapy with R-CHOP (rituximab [Rituxan], cyclophosphamide, doxorubicin, vincristine [Oncovin], prednisone) are considered primary refractory, and these patients have very poor outcomes. In the past, they would receive salvage chemotherapy followed by an ASCT. Kamdar says only a quarter of these high-risk patients would achieve long-term remission following ASCT.

This led to an urgent need for CAR T-cell therapy in the second line for these patients. CAR T cells had shown efficacy for R/R BCL, leading to the approval of these therapies in patients with at least 2 prior lines of treatment, the first being axicabtagene ciloleucel (axi-cel; Yescarta) in 2017.1,2

The results of 3 pivotal phase 3 trials of CAR T-cell products were first presented at ASH 2021, comparing them with salvage chemotherapy and ASCT in patients with aggressive non-Hodgkin BCL who relapsed within 12 months of frontline chemoimmunotherapy. The ZUMA-7 trial (NCT03391466) that evaluated axi-cel and the TRANSFORM trial (NCT03575351) that evaluated lisocabtagene maraleucel (liso-cel; Breyanzi) showed significantly higher event-free survival (EFS) rates in patients who received CAR T-cell therapy vs ASCT, but the BELINDA trial (NCT03570892) that evaluated tisagenlecleucel (tisa-cel; Kymriah) failed to show improved EFS over standard-of-care second-line therapy.3-5 Kamdar plans to discuss the possible reasons for the different outcomes of these trials in greater detail in her presentation.

With axi-cel and liso-cel receiving FDA approvals as second-line therapy, CAR T-cell therapy stands to replace ASCT in this stage of sequencing.6,7 Within this high-risk R/R large BCL subset, I will have to say I no longer recommend an ASCT based on these 2 positive studies, and that we take patients to CAR T-cell therapy, Kamdar said.

Kamdars presentation will focus on the outcomes demonstrated by these trials, including the statistically significant EFS, progression-free survival, and complete response rate of CAR T-cell therapy. Additionally, she will discuss the manageable levels of toxicity seen in the 2 positive trials, with no grade 4 or 5 cytokine release syndrome or neurotoxicity being reported. Longer follow-up is needed to observe overall survival outcomes and other long-term impacts of these therapies.

Despite these results, CAR T-cell therapy is not an option for those who are chemotherapy-sensitive who relapsed more than 12 months after frontline therapy. Currently, ASCT remains the standard of care, Kamdar said. But itd be nice to see [whether] there is something else that can actually be better.

Additionally, the role of CAR T-cell therapy is being investigated in patients who are transplant-ineligible in the phase 2 TRANSCEND-PILOT 017006 study (NCT03483103) that evaluates liso-cel. Durable responses to liso-cel were reported in the primary analysis presented at the 2022 American Society of Clinical Oncology Annual Meeting.8

For patients with high-risk R/R BCL, Kamdar says its crucial to start referring patients for CAR T-cell therapy as soon as they are determined to be primary refractory. CAR T-cell therapy is certainly a process that takes time, because manufacturing of the cells requires a minimum of 17 to 34 days based on the construct you choose, she said. Additionally, insurance approvals and logistical concerns can cause further delays to starting therapy. CAR T-cell production time and accessibility may be improved by new approaches that are being investigated, including allogeneic CAR T cells that do not require patients to undergo leukapheresis.

One rising area of need is therapies for patients who fail CAR T-cell therapy, who may have limited treatment options if they are CD19 negative. Kamdar anticipates that novel therapies, including bispecific antibodies, bispecific T-cell engagers, and natural killer T cells, could fill this unmet need in patients with R/R BCL. [Approximately] 20% of patients [in recent trials of bispecific agents] may have actually received prior CAR T-[cell therapy], and they are showing a response in patients who have failed prior CAR T-cell therapy, she said.

She suggests novel time-limited bispecific therapies will not only benefit those who relapsed or who cannot receive CAR T-cell therapy, but they are also valuable for physicians who want to treat patients while waiting to start CAR T-cell therapy.

Kamdar is looking forward to discussing the shift from ASCT to CAR T-cell therapy in second-line therapy in greater detail at SOHO 2022. Im very excited to see all my colleagues after so long, Kamdar said. Im thrilled to be able to connect in person with everyone. Its been too long.

REFERENCES:

1. Schuster SJ, Svoboda J, Chong EA, et al. Chimeric antigen receptor T cells in refractory B-cell lymphomas.N Engl J Med. 2017;377(26):2545-2554. doi:10.1056/NEJMoa1708566

2. FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma. News release. FDA; October 18, 2017. Updated March 21, 2018. Accessed August 25, 2022. https://bit.ly/3ANA0k5

3. Locke FL, Miklos DB, Jacobson CA, et al. Axicabtagene ciloleucel as second-line therapy for large B-cell lymphoma.N Engl J Med. 2022;386(7):640-654. doi:10.1056/NEJMoa2116133

4. Kamdar M, Solomon SR, Arnason J, et al. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022;399(10343):2294-2308. Published correction appears in Lancet. 2022;400(10347):160.

5. Bishop MR, Dickinson M, Purtill D, et al. Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma.N Engl J Med. 2022;386(7):629-639. doi:10.1056/NEJMoa2116596

6. FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma. FDA. April 1, 2022. Accessed August 25, 2022. https://bit.ly/3ANmZab

7. FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphoma. FDA. June 24, 2022. Accessed August 25, 2022. https://bit.ly/3Q52NVT

8. Seghal A, Hoda D, Riedell PA, et al. Lisocabtagene maraleucel (liso-cel) as second-line (2L) therapy for R/R large B-cell lymphoma (LBCL) in patients (pt) not intended for hematopoietic stem cell transplantation (HSCT): primary analysis from the phase 2 PILOT study. J Clin Oncol. 2022;40(suppl 16):7062. doi:10.1200/JCO.2022.40.16_suppl.7062

Visit link:
Second-Line BCL Treatment Landscape Shifts From ASCT to CAR T-Cell Therapy - Targeted Oncology

Dr. Tania Small Appointed to the Board of Governors of the Accreditation Council for Medical Affairs – citybiz

By Stem Cell Medicine

Dr. Tania Small, MD

NEW YORK(BUSINESS WIRE)The Accreditation Council for Medical Affairs announces the appointment of Tania Small, MD, Global Head of Oncology Medical Affairs and Chair of R&D Diversity, Equity, and Inclusion Council at GSK, to its board of governors today.

The ACMA has both US and international presence in over 80 countries. It is highly recognized for its accredited board certification, and the Board-Certified Medical Affairs Specialist (BCMAS) program designed for pharmaceutical industry medical affairs and medical science liaison (MSL) professionals. Additionally, the ACMA is regarded as the pre-eminent thought leader in US and global medical affairs.

Through her leadership, Dr. Tania Small will make a significant contribution to the mission of ACAM as we continue to raise the bar for pharmaceutical executives with a focus on Medical Affairs and Medical Science Liaisons (MSLs).

We are honored to have Dr. Small join the ACMA Board. Tania is a highly respected professional in the life sciences industry. She is known for driving innovation that improves the experience and supports better outcomes of people living with cancer, said Dr. William Soliman, CEO and Founder of ACMA.

Dr. Small will play a critical role in helping to expand the mission of the ACMA in the life sciences industry. ACMA will continue to collaborate with the government, healthcare policy consortiums, pharmaceutical companies, and patient advocacy organizations to ensure that the ACMA continues to operate at the highest standards of ethics and compliance to achieve this broader mission.

I am honored to be joining the ACMA Board of Governors. They have been instrumental in positively shaping healthcare policy and dialogue. The ACMA is bringing forth a new era in the pharmaceutical industry by providing credible board certification for medical affairs / MSL professionals. An ACMA accreditation enhances MSL professionals ability to deliver upon their critical mission to healthcare providers and patients in need, said Dr. Small.

About Dr. Tania SmallTania Small, Global Head of Oncology Medical Affairs and Chair of R&D Diversity, Equity, and Inclusion Council at GSK, has built and leads an organization of medical professionals focused on patient-driven science. She is passionate about creating groundbreaking solutions that will successfully deliver transformational medicines and access mechanisms, which are needed to revolutionize both the experience and outcomes of people living with cancer and their treatment teams.

A board-certified pediatric hematologist/oncologist, Dr. Small has deep experience in clinical research and drug development. She was trained in hematology/oncology and bone marrow transplantation at Columbia University, where she also completed a genetic research fellowship. She subsequently continued her focus on both hematology and stem cell transplant at New York Presbyterian Hospital and received several grants for her translational research in gene therapy and regenerative medicine.

In previous roles with Novartis Oncology and Ipsen, Dr. Small successfully led the launch of multiple oncology therapies while overseeing programs for both clinical development and medical affairs. She has also led many patient-centered and diversity programs, working closely with the US FDA, Congress, and the American Society of Clinical Oncology (ASCO) to improve the diversity of enrollment in oncology clinical trials and elderly programs.

About Accreditation Council for Medical Affairs (ACMA)The Accreditation Council for Medical Affairs (ACMA) is highly regarded for its Board-Certified Medical Affairs Specialist (BCMAS) program. It is the worlds first and only board certification for MSL and medical affairs professionals. The ACMA offers a 360 suite of digital solutions for the life sciences industry, including market research, sentiment analysis, CRM tools, and more. The ACMA has the first ever Prior Authorization Certification Specialist (PACS) program to help streamline healthcare insurance hurdles. For more information, visit:www.medicalaffairsspecialist.org

More:
Dr. Tania Small Appointed to the Board of Governors of the Accreditation Council for Medical Affairs - citybiz

HK Develops Precision Cure to Help Children with Blood Cancer Prolong Life – The Epoch Times

By Stem Cell Medicine

Children with acute myeloid leukemia (AML) who develop drug resistance generally lack treatment options and are deemed incurable. Recently, The CUHKs HK-HOPE developed a method to obtain the sensitivity of a patients cancer cells to a basket of targeted drugs within three days. In combination with genomic analyses, AML patients are matched with the most effective drugs according to their individual conditions.

AML is a rare but highly aggressive blood cancer that accounts for five percent of pediatric cancers. In Hong Kong, there are about 10 new cases per year. Chemotherapy with stem cell transplantation has remained the standard of care for decades. Advances in medical development have significantly improved the overall survival rate of newly diagnosed AMLpateints to 70 percent. However, the chance of survival drops below 40 percent for patients who develop relapses.

The research team of CUHKs HK-HOPE performed comprehensive drug and genomic profiling of bone marrow biopsies from 52 children with AML and integrated it with their clinical parameters to deliver the first high-dimensional gene-drug-clinical dataset. It has been made freely accessible to all researchers around the globe to stimulate further basic, translational and clinical research on this rare blood cancer.

From the dataset, the researchers also uncovered a children-specific pattern of drug response, linkage to genetic mutations, and active targeted agents with immediate clinical relevance. The study identified a wealth of targeted agents from an approved drug library showing better effectiveness over standard chemotherapeutics against pediatric leukemia. The findings enable the prioritization of new drugs to be tested in upcoming clinical trials.

Through the drug and genomic analysis, the team developed the first precision medicine for pediatric leukemia patients. This enables evidence-based drug selection for relapse cases that can extend patients survival or even cure the disease.

Professor Leung Kam Tong, Assistant Professor of the Department of Pediatrics at CU Medicine, said that with that testing method, they could obtain drug sensitivity testing results within three days. In combination with genomic analysis, they could match the correct drugs to individual leukemia patients who had no further treatment options in a timely manner, bringing hope to those sick kids.

Professor Li Chi Kong, Professor of the Department of Paediatrics at CUHKs Faculty of Medicine (CU Medicine), stated that a 14-year-old AML patient using the new precision medicine approach had experienced a relieving condition with his survival extended by two and a half years, fulfilling the patients wish.

After treatment, another 14-month-old patient also experienced disease remission with significantly prolonged survival.

Professor Albert Martin Li, Director of HK-HOPE and Chairman of CU Medicines Department of Pediatrics, added that they had successfully implemented precision medicine-guided management in childhood AML patients by making good use of valuable data and that the personalized medicine approach could be extended to other leukemia types.

The studys findings have been published in Blood Cancer Discovery, a journal of the American Association for Cancer Research.

See the rest here:
HK Develops Precision Cure to Help Children with Blood Cancer Prolong Life - The Epoch Times

Announcement Of Additional Training Days For Cell therapy Certification in Cancn – Digital Journal

By Stem Cell Clinic

TheInternational Society for Stem Cell Application (ISSCA)announced that it would conduct a regenerative medicine certification training course in stem cell therapy in Cancun, Mexico, from 7th to 8th October. Now, the ISSCA is thrilled to announce that the original training course has been sold out. Those still interested in taking this stem cell therapy course will also be glad to know that the ISSCA has scheduled a new opening date: from 9th to 10th October.

This announcement is driven by the growing demand for doctors in Mexico to learn and include stem cell therapy in their services. We are excited to learn that our upcoming course on cell therapy in Cancun, Mexico has sold out, which shows that more and more physicians want to implement regenerative medicine in their clinics, says Benito Novas, Founder and CEO of Global Stem Cells Group (GSCG). ISSCA is an educational division of GSCG.

New Opening Date, Same Training Course

There is a new date open to doctors who were not able to register on the original date..The skills and lessons taught remain the same, giving trainees in the second shift access to the same knowledge as those in the original shift.

This two-day course will teach how to harvest bone marrow and adipose stem cells from patients in a clinical setting. It is designed for physicians and high-level practitioners.

The first day will cover the courses theoretical portion, familiarizing the doctors with the subject. The second day will then cover the courses practical portion using live cases of various clinical applications of stem cells and exosomes in a clinical setting.

Doctors will learn skills to help them treat their patients more effectively. These skills will also help advance their careers, especially considering the growing importance of stem cell therapy across multiple medical fields. The course will only be available for eight people, so time is of the essence for those who wish to book a spot. Visit https://cursocelulasmadre.com/cursosde-certificacion/cursos-presenciales/ to learn more about the course and register.

About the Global Stem Cells Group(GSCG)

Global Stem Cells Group is the parent company of six companies that are dedicated to stem cell research, solutions, and technology training. The group was founded in 2012 and combines dedicated researchers, patient educators, and physician trainers with the shared goal of meeting the need for high-end stem cell solutions and treatments.

Given that the group has a singular focus in this field, it is uniquely positioned to become the global leader in cellular medicine. In addition, by bringing together leading professionals in cellular medicine, it can discover issues that the industry faces and focus its research and development in this area. This specialization has, undoubtedly, enabled it to come up with solutions that address some of the significant issues that most stakeholders are facing in the industry.

Global Stem Cells Group is a publicly traded company operating under the symbol MSSV.https://finance.yahoo.com/quote/mssv/

About theInternational Society for Stem Cell Application (ISSCA)

ISSCA is the educational division of GSCG. It is also a multidisciplinary group of scientists and physicians exploring various ways of advancing the technology, science, and practice of regenerative medicine. The group aims to assume a leadership position in regenerative medicines research, publication, education, training, and certification standards. ISSCA has trained more than 10,000 physicians worldwide and adopts a hands-on approach by offering certification training worldwide, spreading the practice of regenerative medicine. Their main goal is to treat diseases more effectively, thereby reducing human suffering.

Media Contact Company Name: ISSCA Contact Person: Benito Novas Email: Send Email Phone: (305) 560-5337 Address:Datran Center 9100 S Dadeland Boulevard, Suite 1500 City: Miami State: Fl. 33156 Country: United States Website: https://www.issca.us/

View original post here:
Announcement Of Additional Training Days For Cell therapy Certification in Cancn - Digital Journal

Long-Term Data from Omidubicel Phase 3 Trial Demonstrates Overall Survival and Sustainable Durable Outcomes for Patients with Blood Cancers at the…

By Stem Cell Clinic

BOSTON--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today announced the presentation of new long term follow-up data and health-related quality of life scores of patients treated with omidubicel at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO), being held in Houston, Texas.

These data reinforce our commitment to advance transformational cell therapy research and underscore the potential of our NAM technology platform. Our lead stem cell therapy candidate, omidubicel, addresses the unmet need for patients with hematologic malignancies, demonstrated by the robust and growing body of encouraging clinical evidence, including the long-term follow up data and quality of life improvement, said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. As we approach the PDUFA date of January 30, 2023, and upon potential FDA approval, we are prepared to execute our plan that ensures access to those patients who can benefit from omidubicel as quickly as possible.

The long-term, durable clinical benefit of omidubicel was observed at three years across a patient population that typically has a poor prognosis. A study titled, Multicenter Long-Term Follow Up of Allogeneic Hematopoietic Stem Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials, highlighted long-term follow-up of 105 patients transplanted with omidubicel between 2006-2020 (median follow-up of 22 months). The data demonstrated an overall survival and disease-free survival of 63% (95% CI, 53%-73%) and 56% (95% CI, 47%-67%) at three years, respectively, as well as durable long-term hematopoiesis and immune competence. Learn More

Overall well-being health-related quality of life scores for patients treated with omidubicel demonstrated clinical benefit compared to standard of care. A study titled, Health-Related Quality of Life Following Allogeneic Hematopoietic Stem Cell Transplantation with Omidubicel Versus Standard Umbilical Cord Blood featured an analysis of 108 patients that completed validated health-related quality of life (HRQL) surveys on screening and days 42, 100, 180, and 365 post-transplant. Measures of physical and functional well-being and other HRQL scores were more favorable with omidubicel. These data suggest clinically meaningful and sustained improvements in physical, functional, and overall well-being compared to umbilical cord blood transplantation. Learn More

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types including stem cells and natural killer cells with appropriate growth factors to maintain the cells active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

About Omidubicel

Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.

Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit https://www.gamida-cell.com.

About Gamida Cell

Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapy candidates with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of initiation and progress of, and data reported from, the clinical trials of Gamida Cells product candidates (including omidubicel), regulatory filings submitted to the FDA (including the potential timing of the FDAs review of the BLA for omidubicel), commercialization planning efforts, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cells product candidates (including omidubicel), and Gamida Cells expectations for the expected clinical development milestones set forth herein. Any statement describing Gamida Cells goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to the impact that the COVID-19 pandemic could have on our business, and including the scope, progress and expansion of Gamida Cells clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (SEC) on May 12, 2022, as amended, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cells forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.

1CIBMTR 2019 allogeneic transplants in patients 12+ years with hematological malignancies. 2Gamida Cell market research

Follow this link:
Long-Term Data from Omidubicel Phase 3 Trial Demonstrates Overall Survival and Sustainable Durable Outcomes for Patients with Blood Cancers at the...

Sierra Space, UC San Diego Partner to Develop the First Stem Cell Research Institute in Space – Business Wire

By Stem Cell Clinic

LOUISVILLE, Colo.--(BUSINESS WIRE)--Sierra Space, a leading commercial space company at the forefront of building the future of space transportation and infrastructure for low-Earth orbit (LEO) commercialization, and University of California San Diego, one of the worlds top 15 research universities and a leader in microgravity research, have formed a new agreement with the goal of defining the future of human health care research in space.

In a new Memorandum of Understanding (MOU) between the two organizations, Sierra Space and UC San Diego agreed to collaborate on Orbital Reef, the first commercial space station in LEO, to expand the universitys Integrated Space Stem Cell Orbital Research (ISSCOR) program, which is currently operational on the International Space Station (ISS). Together they will help define and shape the future of biotech and biopharma research and development in microgravity.

This agreement with UC San Diego is a major breakthrough in human health care research conducted in space and signals the beginning of a new era of discovery, said Tom Vice, Sierra Space CEO. Through our collaboration, the highly impactful work that researchers are already doing on the International Space Station today can expand and deliver even greater impact for humanity. As the ISS completes its time in service, UC San Diego will now have a place to grow and expand its vital research in biotech and biopharma with full, on-orbit biomanufacturing and biofabrication centers to foster breakthrough advancements and products in medical science that will benefit all life on Earth.

Microgravity and radiation exposure in low-Earth orbit offers a unique opportunity to study stem cell aging and pre-cancer development in a compressed time frame in a manner that is unavailable on Earth, said Catriona Jamieson, MD, PhD, a stem cell biologist, hematologist and director of the new UC San Diego Sanford Stem Cell Institute, funded with a $150 million gift from philanthropist T. Denny Sanford.

In collaboration with NASA, our Integrated Space Stem Cell Orbital Research team has launched six missions carrying stem cells and stem cell-derived organoids into LEO. We are learning things that we never could under normal gravity; knowledge that can elevate the search for new pre-cancer diagnostics and therapeutics that eradicate cancer at its earliest stages into addition to a broad array of degenerative diseases that arise as a result of stem cell dysfunction.

UC San Diego will provide input to Sierra Space on the design and concept of operations for providing new, state-of-the-art biomanufacturing, biofabrication and related in-space laboratory capabilities and services to industry, academia and government researchers. The university will also participate in a Sierra Space-led in-space biomanufacturing research consortium of industry, academia, philanthropic and government researchers that will focus on R&D objectives, priorities and technical requirements.

Sierra Space will lead the development, launch and deployment of space habitats to establish the necessary infrastructure for UC San Diego and other partners to conduct microgravity research and in-space manufacturing. The companys Dream Chaser spacecraft, the worlds only winged commercial spaceplane, will provide transportation to LEO, while its Large Integrated Flexible Environment (LIFE) modules will offer ample habitable spaces in which to live and work on orbit.

Sierra Space recently made two key appointments to lead development of research capabilities for future LEO commercialization. Dr. Jonathan Volk, Senior Manager of In-Space Manufacturing and Advanced Materials joined the company from Space Commerce Matters where he was the Director of Commercialization Strategies. Prior to this role, Volk was the Commercial Innovation Manager for Physical and Materials Science at the Center for the Advancement of Science in Space (CASIS), which managed the U.S. National Laboratory on the ISS. Dr. Marc Giulianotti takes on the role of Senior Manager, In-Space Biomanufacturing, joining Sierra Space from his role as Director of Science and Technology with the ISS U.S. National Laboratory. Dr. Giulianotti also has more than 20 years working in early drug discovery efforts at the Torrey Pines Institute for Molecular Studies. Both Volk and Giulianotti will focus on advancing the transformative research and technologies in the commercial space destinations of the future.

About Sierra Space

Sierra Space (www.sierraspace.com) is a leading commercial space company at the forefront of innovation and the commercialization of space. Sierra Space is building platforms in space to benefit life on Earth. The company is in the latter stages of doubling its headcount, with large presences in Colorado, Florida and Wisconsin. Significant investors in Sierra Space include General Atlantic, Coatue, and Moore Strategic Ventures.

With more than 30 years and 500 missions of space flight heritage, Sierra Space is enabling the future of space transportation with Dream Chaser, the worlds only winged commercial spaceplane. Under construction at its Colorado headquarters and expected to launch in 2023 on the first of a series of NASA missions to the International Space Station, Dream Chaser can safely carry cargo - and eventually crew - to on-orbit destinations, returning to land on compatible commercial airport runways worldwide. Sierra Space is also building an array of in-space destinations for low-Earth orbit (LEO) commercialization including the LIFE (Large Integrated Flexible Environment) habitat at the Kennedy Space Center in Florida, a three-story commercial habitation and science platform designed for LEO. Both Dream Chaser and LIFE are central components to Orbital Reef, a mixed-use business park in LEO being developed by principal partners Sierra Space and Blue Origin, which is expected to be operational by 2027.

About UC San Diegos Sanford Stem Cell Clinical Center

Sanford Stem Cell Clinical Center (Sanford Center) is among the Universitys most highly visible and top priority interdisciplinary and multi-institutional programs. Sanford Center provides essential physical and human resources needed to leverage stem cell research currently being conducted at UC San Diego. Due to the complexity of regenerative medicine projects and substantial institutional investment, on a daily basis Sanford Center personnel works with a large variety of departments in Health Sciences, Health System, and the school of engineering.

As part of UC San Diego Health, Sanford Center motivates University-wide change and sustainability, focusing on creating the structure under which various innovative regenerative medicine units and initiatives are developed. Sanford Center has led several successful and highly visible interdisciplinary faculty recruitments, committing to over $48M towards faculty start-up, retention, and research funds for over 25 faculty members. Sanford Center also played a pivotal role in securing over $77M of grants from California Institute of Regenerative Medicine (CIRM), awarded respectively to dept. of Bioengineering, Pediatrics, Cellular & Molecular Medicine, Medicine, Neurosciences, and Sanford Center.

Read more:
Sierra Space, UC San Diego Partner to Develop the First Stem Cell Research Institute in Space - Business Wire

Therapeutic Solutions International Identifies CD103 Expressing Dendritic Cells and Exosomes Thereof as Novel Mechanism for JadiCell Mesenchymal Stem…

By Stem Cell Clinic

Clinical Stage Stem Cell Company Leverages Knowledge Gained from Cancer Dendritic Cell Therapy StemVacs to Open New Door for COPD and ARDS Research

ELK CITY, Idaho, October 03, 2022--(BUSINESS WIRE)--Therapeutic Solutions International (TSOI) announced today new data suggesting that therapeutic effects of its universal donor stem cell product are mediated in part through CD103 expressing dendritic cells.

In a series of experiments, it was found that protection against both Chronic Obstructive Pulmonary Disease (COPD) and Acute Respiratory Distress Syndrome (ARDS) could be transferred to nave mice by dendritic cells expressing the molecule CD103. Furthermore, exosomes, which are nanoparticles produced by cells, were capable of transferring protection to nave mice.

"I am pleased to have worked with a team of opinion leaders that are at the cutting edge to have discovered this quite unexpected finding," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "While the field of exosome therapeutics is growing exponentially, the use of dendritic cell exosomes for respiratory conditions is completely unheard of."

Therapeutic Solutions International is currently running a Phase III clinical trial using JadiCells in the treatment of COVID-19 associated ARDS. Additionally, the Company has an Investigational New Drug Application IND# 28508 for treatment of COPD, for which the Company is still in discussions with the FDA.

"Dr. Veltmeyer has performed unparalleled work in advancing both clinical translation of the JadiCell, as well as leveraging scientific lessons learned from our cancer program to identify a new mechanism by which our cells exert this previously unknown therapeutic efficacy," said Timothy Dixon, President, and CEO of the Company. "Having filed our patent today on this new finding, we anticipate potential development of adjuvant products around dendritic cell generated exosomes."

Story continues

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is http://www.therapeuticsolutionsint.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221003005541/en/

Contacts

Timothy G. Dixon ir@tsoimail.com

Read the original post:
Therapeutic Solutions International Identifies CD103 Expressing Dendritic Cells and Exosomes Thereof as Novel Mechanism for JadiCell Mesenchymal Stem...

Growth in Cell and Gene Therapy Market – Pharmaceutical Technology Magazine

By Stem Cell Clinic

Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.

Cell and gene therapies (CGTs) offer significant advances in patient care by helping to treat or potentially cure a range of conditions that have been untouched by small molecule and biologic agents. Over the past two decades, more than 20 CGTs have been approved by FDA in the United States and many of these one-time treatments cost between US$375,00 and US$2 million a shot (1). Given the high financial outlay and patient expectations of these life-saving therapies, it is essential that manufacturers provide integrated services across the whole of the supply chain to ensure efficient biomanufacturing processes and seamless logistics to reduce barriers to uptake.

The following looks at the who, what, when, and why of biomanufacturing and logistics in CGTs in the bio/pharmaceutical industry in more detail.

According to market research, the global gene therapy market will reach US$9.0 billion by 2027 due to favorable reimbursement policies and guidelines, product approvals and fast-track designations, growing demand for chimeric antigen receptor (CAR) T cell-based gene therapies, and improvements in RNA, DNA, and oncolytic viral vectors (1).

In 2020, CGT manufacturers attracted approximately US$2.3 billion in investment funding (1). Key players in the CGT market include Amgen, Bristol-Myers Squibb Company, Dendreon, Gilead Sciences, Novartis, Organogenesis, Roche (Spark Therapeutics), Smith Nephew, and Vericel. In recent years, growth in the CGT market has fueled some high-profile mergers and acquisitions including bluebird bio/BioMarin, Celgene/Juno Therapeutics, Gilead Sciences/Kite, Novartis/AveXis and the CDMO CELLforCURE, Roche/Spark Therapeutics, and Smith & Nephew/Osiris Therapeutics.

Many bio/pharma companies are re-considering their commercialization strategies and have re-invested in R&D to standardize vector productions and purification, implement forward engineering techniques in cell therapies, and improve cryopreservation of cellular samples as well as exploring the development of off-the-shelf allogeneic cell solutions (2).

The successful development of CGTs has highlighted major bottlenecks in the manufacturing facilities, and at times, a shortage of raw materials (3). Pharma companies are now taking a close look at their internal capabilities and either investing in their own manufacturing facilities or outsourcing to contract development and manufacturing organizations (CDMOs) or contract manufacturing organizations (CMOs) to expand their manufacturing abilities (4). Recently, several CDMOsSamsung Biologics, Fujifilm Diosynth, Boehringer Ingelheim, and Lonzahave all expanded their biomanufacturing facilities to meet demand (5).

A major challenge for CGT manufacturers is the seamless delivery of advanced therapies. There is no room for error. If manufacturers cannot deliver the CGT therapy to the patient with ease, the efficacy of the product becomes obsolete. Many of these therapies are not off-the-shelf solutions and therefore require timely delivery and must be maintained at precise temperatures to remain viable. Thus, manufacturers must not only conform to regulations, but they must also put in place logistical processes and contingency plans to optimize tracking, packaging, cold storage, and transportation through the products journey. Time is of the essence, and several manufacturers have failed to meet patient demands, which have significant impacts on the applicability of these agents.

Several CAR T-cell therapies have now been approved; however, research indicates that a fifth of cancer patients who are eligible for CAR-T therapies pass away while waiting for a manufacturing slot (6). Initially, the manufacture of many of these autologous products took around a month, but certain agents can now be produced in fewer than two weeks (7). Companies are exploring new ways to reduce vein-to-vein time (collection and reinfusion) through the development of more advanced gene-transfer tools with CARs (such as transposon, CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) among others, and the use of centralized organization with standardized apheresis centers (5). Others are exploring the use of the of allogeneic stem cells including Regen Biopharma, Escape Therapeutics, Lonza, Pluristem Therapeutics, and ViaCord (7).

Several gene therapies have also been approved, mainly in the treatment of rare disease (8). Many companies are evaluating novel gene therapy vectors to increase levels of gene expression/protein productions, reduce immunogenicity and improve durability including Astellas Gene Therapies, Bayer, ArrowHead Pharmaceuticals, Bayer, Bluebird Bio, Intellia Therapeutics, Kystal Biotech, MeiraGTx, Regenxbio, Roche, Rocket Pharmaceuticals, Sangamo Therapeutics, Vertex Pharmaceuticals, Verve Therapeutics, and Voyager Therapeutics (8).

While many biopharma companies have established their own in-house CGT good manufacturing practice (GMP) operation capabilities, others are looking to decentralize manufacturing and improve distribution by relying on external contracts with CDMOs and CMOs such as CELLforCURE, CCRM, Cell Therapies Pty Ltd (CTPL), Cellular Therapeutics Ltd (CTL), Eufets GmbH, Gravitas Biomanufacturing, Hitachi Chemical Advances Therapeutic Solutions, Lonza, MasTHerCell, MEDINET Co., Takara Bio, and XuXi PharmaTech (6, 9, 10).

The top 50 gene therapy start-up companies have attracted more than $11.6 billion in funds in recent years, with the top 10 companies generating US$5.3 billion in series A to D funding rounds (10). US-based Sana Biotechnology leads the field garnering US$700 million to develop scalable manufacturing for genetically engineered cells and its pipeline program, which include CAR-T cell-based therapies in oncology and CNS (Central Nervous System) disorders (11). In second place, Editas Medicine attracted $656.6 million to develop CRISPR nuclease gene editing technologies to develop gene therapies for rare disorders (12).

Overall, CGTs have attracted the pharma industrys attention as they provide an alternative route to target diseases that are poorly served by pharmaceutical and/or medical interventions, such as rare and orphan diseases. Private investors continue to pour money into this sector because a single shot has the potential to bring long-lasting clinical benefits to patients (13). In addition, regulators have approved several products and put in place fast track designation to speed up patient access to these life-saving medicines. Furthermore, healthcare providers have established reimbursement policies and manufacturers have negotiated value- and outcome-based contracts to reduce barriers to access to these premium priced products

On the downside, the manufacture of CGTs is labor intensive and expensive with manufacturing accounting for approximately 25% of operating expenses, plus there is still significant variation in the amount of product produced. On the medical side, many patients may not be suitable candidates for CGTs or not produce durable response due to pre-exposure to the viral vector, poor gene expression, and/or the development of immunogenicity due to pre-exposure to viral vectors. Those that can receive these therapies may suffer infusion site reactions, and unique adverse events such as cytokine release syndrome and neurological problems both of which can be fatal if not treated promptly (14).

Despite the considerable advances that have been made in the CGT field to date, there is still much work needed to enhance the durability of responses, increase biomanufacturing efficiencies and consistency and to implement a seamless supply chain that can ensure these agents are accessible, cost-effective, and a sustainable option to those in need.

Cleo Bern Hartley is a pharma consultant, former pharma analyst, and research scientist.

Pharmaceutical Technology Volume 46, Number 10 October 2022 Pages: 54-55

When referring to this article, please cite it as C.B. Hartley, "Growth in Cell and Gene Therapy Market," Pharmaceutical Technology 46 (10) 5455 (2022).

Read the original:
Growth in Cell and Gene Therapy Market - Pharmaceutical Technology Magazine

→←