Stem Cell Clinic

CIRM Alpha Stem Cell Clinic | UC San Diego Health

An overview of the CIRM Alpha Stem Cell Clinic at UC San Diego Health

The mission of the Alpha Stem Cell Clinic at UC San Diego Health is to accelerate the development, implementation and administration of safe and effective stem cell-based human therapies.

The Alpha Stem Cell Clinic at UC San Diego Health is one of five alpha clinics in a network designated by the California Institute for Regenerative Medicine (CIRM), the states stem cell agency. It is the cell therapy arm of the Sanford Stem Cell Clinical Center that specializes in early phase, first-in-human trials. Visit the Sanford Stem Cell Clinical Center's website.

The alpha clinics are intended to create the long-term, networked infrastructure needed to launch and conduct numerous, extensive clinical trials of stem cell-related drugs and therapies in humans, including those developed by independent California-based investigators and companies. These trials are requisite before any new drug or treatment can be approved for clinical use.

The clinics will emphasize public education to raise awareness and understanding of stem cell science. This will combat stem cell tourism and the marketing of unproven, unregulated and potentially dangerous therapies. The clinics will also help establish sustainable business models for future, approved stem cell treatments.

To learn more about participating Alpha Clinics, please visit each clinic's dedicated webpage:

Our current clinical trials include:

Breast Cancer

Chronic Heart Failure

Degenerative Disc Disease

Gastrointestinal

Glioblastoma

Myelodysplastic Syndrome

Find other clinical trials at UC San Diego Health

Learn about how clinical trials work

The Alpha Stem Cell Clinic at UC San Diego Health can provide administrative and other relevant support to scientists and physicians at various stages of development and implementation of clinical trials using stem cell-related therapies.

The Division of Regenerative Medicine at UC San Diego School of Medicine is dedicated to delivering superb state-of-the-art clinical care and bringing the advancement of scientific research in regenerative medicine to the forefront of public and scientific spheres both locally and globally.

The UC San Diego Health / Sharp HealthCare Joint Blood and Marrow Program is the largest blood and marrow transplant (BMT) program in San Diego, one of the largest in California, and a national leader in physician expertise and state-of-the-art treatment.

The Sanford Surgical Training Center supports pre-clinical studies and hands-on training of neurosurgical techniques. Experimental models of spinal and peripheral nerve injury are available for testing pre-clinical cell replacement therapies, clinical immunosuppression protocols in allogeneic and syngeneic cell grafting designs, and organ experimentation and cell grafting. Qualified investigators may be trained on the use of FDA-approved spinal and brain injection devices. The Sanford Surgical Training Center is also working to partner with local contract research organizations (CROs) to develop the infrastructure and administrative support needed to conduct good laboratory practice (GLP) studies.

The UC San Diego Division of Regenerative Medicine will hold its Fifth Annual Symposium on March 15, 2019 at Sanford Consortium for Regenerative Medicine.

This symposium brings together stakeholders from academia, industry, government and the public to discuss developments needed to turn stem cell-based therapies into approved products for patients in need. The program highlights stem cell regeneration in different disease areas and developments with industry partners. An interactive panel will discuss the pitfalls and successes of current stem cell clinical trials.

See the agenda and register for the event

Watch talks from the 2019 symposium on YouTube

Current Enrollment Period: Spring 2019 The UC San Diego CIRM Alpha Stem Cell Clinic is committed to educating patients and professionals, including study staff. We are pleased to invite all clinical research professionals, from coordinators to physicians, to enroll in Translating Stem Cells (CLRE-237).

This 20-hour course is offered via CTRI CREST program. The course may also count as an elective in the MAS program, but applicants do not necessarily need to be enrolled in either the CREST or MAS program to take this course!

The enrollment period is currently closed. Please contact CTRI CREST program with questions, and apply here.

See this downloadable flyer for more information.

Contact

Betty Cabrera, MPH, CCRC Clinical Operations Manager, UC San Diego CIRM Alpha Stem Cell Clinic Phone: 858-534-5932 blcabrera@ucsd.edu

For more information about the program, please contact:

Betty Cabrera, MPH ClinicalOperations Manager, CIRM AlphaStem Cell Clinic

To view the Alpha Clinic's full multidisciplinary team, please see Leadership and Staff.

Meet our stem cell experts in this video playlist

We all have stem cells and they are necessary for our survival. For example, skin stem cells renew and repair our skin. Cells in our bone marrow generate the different cell types in our blood. The stem cells in our bodies are adult stem cells - unspecialized cells found in a tissue or organ that can yield all the specialized types of cells of that tissue or organ.

The term adult stem cells can be misleading because babies and children have them as well. Adult stem cells are also referred to as multipotent stem cells. Multipotent means that they can only generate the cell types in the particular organ in which they are found. However, some studies suggest that under certain conditions, adult stem cells may be able to give rise to cell types of other tissues as well. Another source of multipotent stem cells is umbilical cord blood.

Stem cells that have the potential to generate the cell types in any organ or tissue in the body are called pluripotent stem cells. Embryonic stem cells are pluripotent. Embryonic stem cells come from a blastocyst- a small sphere of cells that results from cell division in a fertilized egg. For research purposes, cells are harvested from the inner cell mass of the blastocyst when it is approximately six days old and consists of around 200 cells. Recently, cells with properties similar to embryonic stem cells, referred to as induced pluripotent stem cells or iPS cells, have been engineered from specialized cells such as skin cells.

Given their unique abilities to renew themselves, researchers are exploring different avenues for using stem cells to treat disease, including:

Stem cells offer tremendous potential to advance medicine; however, current applications may be sometimes exaggerated by the media and others who may not fully understand the science or limitations. Treatments based on stem cells are largely new and there is much we still need to learn. Researchers believe it may take many years, possibly decades in some cases, to realize the full potential of stem cells to treat disease.

UC San Diego Health doctors, researchers and ethicists advise that it is unethical to charge patients for treatments that have not been validated. Unfortunately, there are people who have taken advantage of stem cell publicity to charge fees for treatments that have not been adequately tested for safety and effectiveness. Alleged treatments are offered for a variety of conditions. The Sanford Stem Cell Clinical Center believes that companies often inaccurately portray treatments as safe and effective for a broad range of injury and disease. Potential side effects are downplayed and testimonials are presented instead of evidence from research articles in reputable scientific journals.

The International Society for Stem Cell Research (ISSCR) has expressed concerns about disreputable clinics.

Numerous clinics around the world are exploiting patients hopes by purporting to offer new and effective stem cell therapies for seriously ill patients, typically for large sums of money and without credible scientific rationale, transparency, oversight, or patient protections. The ISSCR is deeply concerned about the potential physical, psychological, and financial harm to those who pursue unproven stem cell therapies and the general lack of scientific transparency and professional accountability of those engaged in these activities.

See"Nine Things To Know About Stem Cell Treatments" for more information.

You can search for new clinical trials, and changes in existing trials at the U.S. National Institutes of Health database:

If you see trials that are of interest to you, we recommend that you read about them carefully, and then print the trial descriptions out for discussion with your doctor. Please keep in touch with respected physicians whom you know and trust for all aspects of your health care.

The rest is here:
CIRM Alpha Stem Cell Clinic | UC San Diego Health

Stem Cell Assay Industry 2020 Includes The Major Application Segments And Size In The Global Market To 2026 – Sports Skylark

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Stem Cell Assay Industry 2020 Includes The Major Application Segments And Size In The Global Market To 2026 - Sports Skylark

Oncologie Expands and Strengthens Management Team with Key Appointments and Promotions – GlobeNewswire

July 09, 2020 07:00 ET | Source: Oncologie, Inc.

-Appoints Matthew Osborne as Chief Financial Officer-

-Names Hagop Youssoufian, M.D., as Interim Chief Medical Officer-

-Hires Bill McDonald, Ph.D., as Vice President of CMC-

-Promotes Kerry Culm-Merdek, Ph.D., to Vice President of Clinical Development-

WALTHAM, Mass., July 09, 2020 (GLOBE NEWSWIRE) -- Oncologie, Inc., a precision medicine company using an innovative RNA-based biomarker platform to develop novel, targeted oncology therapies, today announced an expansion of its management team with the appointments of Matthew Osborne as Chief Financial Officer, Hagop Youssoufian, M.D., as Interim Chief Medical Officer, Bill McDonald, Ph.D., as Vice President of Chemistry, Manufacturing and Controls (CMC), as well as the promotion of Kerry Culm-Merdek, Ph.D., to Vice President of Clinical Development.

We are pleased to expand Oncologies management team with the additions of Matt, Hagop and Bill, and the promotion of Kerry, and look forward to their contributions, said Laura Benjamin, Ph.D., Founder and CEO of Oncologie. Their collective experience and leadership will be critical as we further develop and deploy our RNA-based biomarker platform to advance the state of the art of precision medicine to identify the right patients for our clinical stage programs, Navicixizumab and Bavituximab.

Mr. Osborne brings to Oncologie more than 20 years of leadership, financial and industry experience, gleaned from years on Wall Street and through professional roles with small to large cap biotechnology companies. In these roles, he successfully led multiple equity financings, applying his expertise across disciplines spanning scientific, financial, strategic planning, investor relations and corporate communications functions. Before joining the company in 2020, Mr. Osborne served as Chief Financial Officer at Unum Therapeutics, Inc. Prior to joining Unum Therapeutics, Mr. Osborne served as Head of Corporate Affairs, Communications and Investor Relations at Voyager Therapeutics, Inc., and through similar roles at Shire, Plc (acquired by Takeda Pharmaceutical Company in 2019), Synageva BioPharma Corp. (acquired by Alexion Pharmaceuticals, Inc. in 2015) and Vertex Pharmaceuticals Incorporated. Mr. Osbornes Wall Street experience includes serving as a sell-side analyst at Lazard Capital Markets and Leerink Swann (now SVB Leerink), where he covered small to large cap biotechnology companies, analyzed drug launches and launched several initial public offerings. He received a B.S. in Biology from Syracuse University and an M.B.A. from the DAmore-McKim School of Business at Northeastern University.

Dr. Youssoufian is a physician-scientist with more than 25 years of experience in drug development working with seed-stage ventures to multi-national biotech and pharmaceutical corporations. After a successful academic career as a clinician, teacher and NIH-funded investigator, he held increasingly senior roles in clinical and translational science including Head of Experimental Medicine at Bristol-Myers Squibb Company, Distinguished Scientist at Sanofi Aventis, Chief Medical Officer at ImClone Systems Incorporated, President of Research and Development and Chief Medical Officer at Ziopharm Oncology, Inc., Executive Vice President of Research and Development at Progenics Pharmaceuticals, Inc., and Chief Medical Officer at BIND Therapeutics, Inc. He supported or led the development and approval of a number of medicines including Sprycel, Taxotere, Erbitux, Cyramza, Lartruvo and Copiktra. He is an elected member of the American Society for Clinical Investigation, the recipient of many national and international awards, and the author of more than 100 publications. He received a B.S. in biology from Boston College and M.Sc./M.D. from University of Massachusetts Medical School, followed by fellowships at Johns Hopkins University, Harvard University and the Massachusetts Institute of Technology.

William Bill McDonald, Ph.D., brings more than 20 years of experience in process development and the manufacturing of antibodies, recombinant enzymes, antigens, antibody targets, viral vectors and vaccines. Prior to joining Oncologie, Bill served as Vice President, CMC at Contrafect Corporation where he was responsible for all CMC activities for Contrafects novel biologics platform of anti-microbial therapies. Previously, Bill served as Executive Director and Manufacturing Site Head at Celldex Therapeutics, Inc., where he oversaw the Fall River GMP manufacturing facility and was responsible for internal manufacturing of all early clinical stage biologics. Bill also held roles of increasing responsibility at Synageva BioPharma Corp. (acquired by Alexion Pharmaceuticals, Inc. in 2015), including Senior Director of Process Development. He also previously served as Head of Process Science at Pfizer, Inc., Director of Antigen Production at Genocea Biosciences Inc. and Director of Biochemistry at VaxInnate Corporation. Within the scope of technical operations, he has supported the development and manufacture of several approved biologics including Kanuma, Soliris and Strensiq. Bill received a B.S. in Microbiology from the University of Florida and received a Ph.D. in Molecular Biology at Cornell University.

Kerry Culm-Merdek, Ph.D., brings over 15 years of clinical drug development expertise and experience in small molecule and therapeutic protein development in rare disease and oncology indications including her role as Head of Clinical Pharmacology and Quantitative Bioanalytics at ImmunoGen Inc., where she was responsible for clinical pharmacology strategy for global clinical and preclinical development of oncology therapies. Prior to joining ImmunoGen, Kerry spent 13 years at Sanofi Genzyme, most recently serving as a Global Project Head, where she led the therapy project teams for Fabry disease, Gaucher disease type 3 and multiple gangliosidosis/galatosialidosis indications. Kerry received a B.S. in Biochemical Pharmacology from the State University of New York at Buffalo. She received a Ph.D. in Pharmacology and Experimental Therapeutics at Tufts University School of Medicine.

About Bavituximab

Bavituximab is an investigational chimeric monoclonal antibody that targets the activity of phosphatidylserine (PS). Bavituximab is believed to reverse PS-mediated immunosuppression by blocking the engagement of PS with its receptors, as well as by sending an alternate immune activating signal. PS-targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses. This mechanism may play an important role in allowing other cancer therapies to more effectively attack tumors by reversing the immunosuppression that limits the impact of those treatments. Oncologie is conducting a Phase 2 trial of bavituximab plus pembrolizumab as a second-line treatment in patients with advanced gastric or gastroesophageal cancer. Using its biomarker platform, Oncologie is analyzing patient tissue samples from this on-going trial with results expected later this year to inform future clinical development for this program.

About Navicixizumab

Navicixizumab is an anti-DLL4/VEGF bispecific antibody designed to inhibit both Delta-like ligand 4 (DLL4) in the Notch cancer stem cell pathway as well as vascular endothelial growth factor (VEGF) and thereby induce potent anti-tumor responses while mitigating certain angiogenic-related toxicities. In preclinical studies, navicixizumab demonstrated robust in vivo anti-tumor activity across a range of solid tumor xenografts, including colon, ovarian, lung and pancreatic cancers, among others. In a Phase 1a trial of 66 patients with various types of refractory solid tumors, treatment with single agent navicixizumab generated an overall response in three of 12 (25%) patients with ovarian cancer. In a Phase 1b trial in platinum-resistant ovarian cancer patients who had failed more than two prior therapies including bevacizumab, treatment with navicixizumab plus paclitaxel generated an interim overall response in 10 of 30 (33%) patients. Treatment-related adverse events in the Phase 1b trial were manageable and included hypertension (58%), headache (29%), fatigue (26%) and pulmonary hypertension (18%). Using its RNA-based biomarker platform, Oncologie is analyzing patient tissue samples from all navicixizumab trials with results expected later this year to inform future clinical development with this program. The FDA granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal or fallopian tube cancer in patients who have received at least three prior therapies and/or prior treatment with bevacizumab.

About Oncologies RNA-based Biomarker Platform

Predictive biomarkers historically worked on single-driver mutations yet only approximately 10% of cancer patients have known driver mutations with available targeted therapies. Using its proprietary biomarker platform, Oncologie is advancing a new paradigm of precision oncology with an RNA-based approach to identify the dominant biology in the tumor microenvironment. This could improve clinical outcomes by matching patients to therapies with a mechanism of action that targets that specific biology and expand precision medicine to those therapies whose potential remains unrealized. Oncologie is further optimizing the biomarker platforms tumor microenvironment panel through multiple research collaborations, including a collaboration with Moffitt Cancer Center.

About Oncologie, Inc.

Oncologie, Inc. aims to advance the state of the art of precision medicine to dramatically improve the lives of people with cancer. Leveraging a deep understanding of the evolving biology of cancer, Oncologie is developing unique RNA-based biomarker panels to match patients to novel, targeted therapies that modulate the bodys tumor immune system and angiogenesis pathways. Oncologie, Inc., based in Waltham, Massachusetts, and Oncologie Shanghai Co., Ltd., based in Shanghai, China, are subsidiaries of Oncologie, Ltd., and are working with global partners to acquire and further develop innovative drugs for cancer patients around the world. For more information on Oncologie, Inc., please visit https://oncologie.com/.

Investor and Media Contact:

Ashley R. Robinson LifeSci Partners, LLC arr@lifesciadvisors.com

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Oncologie Expands and Strengthens Management Team with Key Appointments and Promotions - GlobeNewswire