CIRM Alpha Stem Cell Clinic at UC San Diego Health

UC San Diego Medical Center
Clinical Trials video

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

 

 

CIRM logo

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.

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:

City of Hope logo

UCSF lobo

         

UCLA Stem Cell Clinic logo

        UC Davis Health logo

UC San Diego Health logo

Our current clinical trials include:

Breast Cancer

  • 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
  • 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: Active, 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: Active, 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

Myelodysplastic Syndrome
  • 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
  • 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

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

Admin Support Graphic 

Services

Early Feasability 
  • Support the development of regulatory strategies
  • Assess source material
  • Assist product classification
Early Product Development  
  • Facilitate communication with the United States Food and Drug Administration (FDA) (e.g., pre-pre-IND meeting)
  • Assist initial documentation and document control
Late Product Development  
  • 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
Clinical Trials 
  • 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.

Translational Regenerative Medicine Course

Current Enrollment Period: Spring 2018
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


symposium photos

Third Annual CIRM Alpha Stem Cell Clinics Network Symposium
UCLA-UC Irvine, April 19, 2018

 The UCLA-UC Irvine CIRM Alpha Stem Cell Clinic hosted the 2018 Symposium, "Delivery of Stem Cell Therapeutics to Patients." This symposium highlighted the CIRM Alpha Stem Cell Clinic Network, focusing on what has been achieved to date, and the participants discussed the pathways to commercialization and reimbursement of newly developed therapies. 

See the agenda for a list of speakers

Fourth Annual UC San Diego Division of Regenerative Medicine Symposium 
UC San Diego, March 9, 2018

Watch these talks all in one place on YouTube

The UC San Diego Division of Regenerative Medicine held its 4th Annual Symposium on Friday, March 9, 2018 at Sanford Consortium for Regenerative Medicine. 

This symposium brought 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 highlighted stem cell regeneration in different disease areas and developments with industry partners. An interactive discussion panel addressed the pitfalls and successes of current stem cell clinical trials.

See the agenda for a list of speakers

Videos

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:

  • Catriona Jamieson, MD, PhD
    Deputy 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
  • 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)
  • 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
  • John Ravits, MD
    Trial Expert, Neurology

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

"Meet the experts" videos

Meet our stem cell experts in this video playlist

For more information about the Alpha Stem Cell Clinic at UC San Diego Health, please call 844-317-STEM (7836) or email alphastemcellclinic@ucsd.edu.