An overview of the CIRM Alpha Stem Cell Clinic
at UC San Diego Health
Contact Us
Mission Statement
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.
About the Alpha Stem Cell Clinic
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 state’s 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.
Alpha Stem Cell Clinics Network
To learn more about participating Alpha Clinics, please visit each clinic's dedicated webpage:
Clinical Trials at UC San Diego Health
Our current clinical trials include:
Breast Cancer
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Study of cirmtuzumab and paclitaxel for metastatic or locally advanced, unresectable breast cancer
Researchers at UC San Diego Health are collaborating with Oncternal Therapeutics, Inc. to evaluate the effectiveness of the ROR-1 targeting monoclonal antibody, cirmtuzumab, when given in combination with paclitaxel in people with HER2 negative, metastatic breast cancer. Cirmtuzumab is an investigational drug that is designed to attach to a protein called ROR-1 and block the growth and survival of breast cancer cells.
Status: Active, enrolling
Chronic Heart Failure
Chronic Lymphocytic Leukemia
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UC-961 (cirmtuzumab) in relapsed or refractory chronic lymphocytic leukemia
Researchers at UC San Diego Health are investigating the safety of the investigational drug, cirmtuzumab, in people with relapsed or refractory chronic lymphocytic leukemia (CLL). Cirmtuzumab is a monoclonal antibody that is designed to attach to a protein called ROR-1 and block the growth and survival of CLL cells.
Status: Closed, not enrolling -
Extension study of UC-961 (cirmtuzumab) for patients with chronic lymphocytic leukemia treated previously with UC-961
Researchers at UC San Diego Health are investigating the safety of the investigational drug, cirmtuzumab, for an extended duration of dosing of up to six months in people with relapsed or refractory chronic lymphocytic leukemia (CLL) previously treated in the cirmtuzumab clinical trial. Cirmtuzumab is a monoclonal antibody that is designed to attach to a protein called ROR-1 and block the growth and survival of CLL cells.
Status: Closed, not enrolling -
A study of cirmtuzumab and ibrutinib in patients with b-cell lymphoid malignancies
Researchers at UC San Diego Health are collaborating with Oncternal Therapeutics, Inc. to evaluate the effectiveness of the ROR1-targeting monoclonal antibody, cirmtuzumab, when given in combination with a BTK inhibitor, ibrutinib, in people with chronic lymphocytic leukemia, small lymphocytic leukemia or mantle cell lymphoma.
Status: Active, enrolling
Degenerative Disc Disease
Gastrointestinal
Glioblastoma
Myelodysplastic Syndrome
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Collection of samples from patients with MDS
Researchers at UC San Diego Health are collaborating with PersImmune, Inc. to collect bone marrow, blood, saliva, cheek cells and skin to identify the unique, personalized array of tumor-specific neoantigens in people with myelodysplastic syndromes (MDS).
Status: Active, enrolling -
Personalized adoptive cellular therapy targeting MDS stem cell neoantigens (PACTN)
Researchers at UC San Diego Health are collaborating with PersImmune, Inc. to conduct a safety trial of autologous T-cells that have been immunized ex vivo with tumor-specific neoantigens in people with myelodysplastic syndromes (MDS).
Status: Active, enrolling
Spinal Cord Injury
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Safety study of human spinal cord-derived neural stem cell transplantation for the treatment of chronic spinal cord injury (SCI)
Researchers at UC San Diego Health are collaborating with Neuralstem, Inc. to conduct a safety trial of a human spinal cord-derived neural stem cell line in people with paralysis due to a spinal cord injury. This clinical trial evaluates the safety of transplanting neural stem cells into the spine.
Status: Active, enrolling -
Dose escalation study of AST-OPC1 in spinal cord injury
Researchers at UC San Diego Health are collaborating with Asterias Biotherapeutics, Inc. to conduct a safety trial of oligodendrocyte progenitor cells in people with a cervical spinal cord injury. This clinical trial evaluates the safety of transplanting oligodendrocyte progenitor cells into the spine.
Status: Closed, not enrolling -
A long-term follow-up study of subjects with cervical spinal cord injuries who received AST-OPC1 in protocol AST-OPC1-01
Researchers at UC San Diego Health are collaborating with Asterias Biotherapeutics, Inc. to conduct a long-term follow-up study for participants in the Dose Escalation Study of AST-OPC1 in Spinal Cord Injury.
Status: Closed, not enrolling
Type 1 Diabetes
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A safety, tolerability, and efficacy study of VC-01™ combination product in subjects with type 1 diabetes mellitus
Researchers at UC San Diego Health are collaborating with ViaCyte, Inc. to conduct a Phase I/II clinical trial of a combination product to treat people with type 1 diabetes. The therapy involves implanting a device containing cells under the skin. This clinical trial evaluates the safety, tolerability and effectiveness of the combination product.
Status: Active, not recruiting -
One-year follow-up safety study in subjects previously implanted With VC-01™
Researchers at UC San Diego Health are collaborating with ViaCyte, Inc. to evaluate the long-term safety of VC-01 combination product previously implanted in people with type 1 diabetes.
Status: Active, enrolling by invitation -
A safety, tolerability, and efficacy study of VC-02™ combination product in subjects with type 1 diabetes mellitus and hypoglycemia unawareness
Researchers at UC San Diego Health are collaborating with ViaCyte, Inc. to conduct a Phase I/II clinical trial of a combination product to treat people with type 1 diabetes and hypoglycemia unawareness. The therapy involves implanting a device containing cells under the skin. This clinical trial evaluates the safety, tolerability and effectiveness of the combination product.
Status: Active, not enrolling -
One-Year Follow-up Safety Study in Subjects Previously Implanted With VC-02™
Researchers at UC San Diego Health are collaborating with ViaCyte, Inc. to evaluate the long-term safety of VC-02 combination product previously implanted in people with type 1 diabetes.
Status: Active, enrolling by invitation
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.
Administrative Support
Services
- Support the development of regulatory strategies
- Assess source material
- Assist product classification
- Facilitate communication with the United States Food and Drug Administration (FDA) (e.g., pre-pre-IND meeting)
- Assist initial documentation and document control
- Facilitate communication and compliance with the FDA (e.g., pre-IND meeting)
- Support the preparation of an Investigational New Drug (IND) application or cross reference
- Prepare and submit regulatory documentation
- Assist trial billing set-up and maintenance support
- Assist with patient care coordination and support
- Schedule clinical trial protocol procedures
- Assist biospecimen collection, shipping, and follow-up of research protocol studies
- Provide trial monitoring
- Data management planning and implementation
Division of Regenerative Medicine
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.
Blood and Marrow Transplant Program
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.
Sanford Surgical Training Center
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.
Fifth Annual UC San Diego Division of Regenerative Medicine Symposium
UC San Diego, March 15, 2019
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
Translational Regenerative Medicine Course
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
Other Videos from Past Events
Virtual Grand Rounds
For more information about the program, please contact:
Betty Cabrera, MPH
Clinical Operations Manager, CIRM Alpha Stem Cell Clinic
Phone: 858-534-5932
blcabrera@ucsd.edu
Meet our stem cell physicians:
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Catriona Jamieson, MD, PhD
Director, Sanford Stem Cell Clinical Center
Program Director, CIRM Alpha Stem Cell Clinic at UC San Diego Health -
Eric Adler, MD
Trial Expert, Cardiology -
Edward Ball, MD
Clinical Advisor, UC San Diego CIRM Alpha Stem Cell Clinic
Director, Blood & Marrow Transplant Program -
Michael Choi, MD
Trial Expert, Hematology/Blood Diseases -
Joseph Ciacci, MD
Neurosurgeon, Professor of Surgery -
Wolfgang Dillmann, MD
Trial Expert, Endocrinology
Chair & Helen M. Ranney Distinguished Professor of Medicine -
John Evans, PhD
Ethics, Policy & Counseling Task Force Lead
Professor of Sociology
Associate Dean, Division of Social Science -
Gary Firestein, MD
Professor of Medicine
Dean & Associate Vice Chancellor of Translational Medicine
Director, Clinical and Translational Research Institute (CTRI) -
Benjamin Heyman, MD
Trial Expert, Hematologist -
Daniel Kaufman, MD, PhD
Hematologist, Professor of Medicine -
Thomas Kipps, MD, PhD
Trial Expert, Cancer
Evelyn & Edwin Tasch Chair in Cancer Research
Deputy Director of Research Operations, Moores Cancer Center -
Martin Marsala, MD
Trial Expert, Neurosurgical technique -
Sheldon Morris, MD, MPH
Data Management Lead, CIRM Alpha Stem Cell Clinic at UC San Diego Health -
Jeremy Pettus, MD
Endocrinologist, Assistant Professor of Medicine -
Tiffany Tanaka, MD
Trial Expert, Hematologist
To view the Alpha Clinic's full multidisciplinary team, please see
Leadership and Staff.
"Meet the experts" videos
Meet our stem cell experts in this
video playlist
Frequently Asked Questions about Stem Cells
What are stem cells?
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.
How can stem cells be used to treat disease?
Given their unique abilities to renew themselves, researchers are exploring different avenues for using stem cells to treat disease, including:
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Replacing damaged cells and organs. A wide range of diseases (heart disease, Parkinson’s disease, Alzheimer’s disease, diabetes, motor neuron disease, etc.) may be amenable to stem cell therapy if stem cells can be made to go to the appropriate place in the body and become the appropriate cell type. For example, if stem cells could be made to migrate to an injured spinal cord and become nerve cells, it might be possible to treat paralysis.
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Developing drug therapies. It is possible to make stem cells that are genetically identical to those of a person with a disease such as amyotrophic lateral sclerosis. The stem cells can be made to generate the cell type that is defective in that disease (e.g. nerve cells). By studying these cells, researchers can gain insight into what goes wrong at the molecular level in the disease. They can also use these cells to test drugs that might block the progression of the disease.
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Determining how disease starts. Stem cells are critical for growing and repairing the human body. However, stem cells that have out-of-control proliferation could create precursor cells for cancer. By identifying the mechanisms that enable the ‘cancer stem cell’ to go haywire, researchers might target these specific pathways to treat cancer.
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.
How much do stem cell treatments cost?
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.
Where can I find more information on stem cells?
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.