Clinical Trials at the UC San Diego Alpha Stem Cell Clinic

 

At the UC San Diego CIRM Alpha Stem Cell Clinic, our goal is to bring stem cell-based therapies to patients with unmet medical needs. There are over 50 clinical trials in California's CIRM Alpha Stem Cell Clinics Network. The trials at the UC San Diego Alpha Clinic span many diseases and include UC San Diego-developed cancer treatment, Cirmtuzumab.

 

We invite you to browse our clinical trials below. If you believe you may be a candidate for an Active & Enrolling study, contact the person listed for that study. Some studies are no longer open to new patients, so those are listed as "Not Enrolling."

 

Current Trials:

Breast Cancer

A Phase 1 Clinical Trial to Determine the Safety and Tolerability of Cirmtuzumab, an Anti-ROR1 Monoclonal Antibody, in Combination With Paclitaxel for the Treatment of Patients With Metastatic or Locally Advanced Unresectable Breast Cancer

Researchers at UC San Diego are investigating the safety of the investigational drug called cirmtuzumab in combination with the breast cancer drug, paclitaxel. Cirmtuzumab is a type of drug called a monoclonal antibody. This drug is designed to attach to a protein called ROR1 that is on the surface of breast cancer cells. This blocks growth and survival of the breast cancer cells. ROR1 is rarely expressed on healthy cells so this drug should target the cancer cells.

STATUS: Not Active

Contact: Teresa Rzesiewicz, RN, BSN, PHN, CCRC (858) 534-5869 trzesiewicz@ucsd.edu
Trial Sponsor: UC San Diego

Chronic Heart Failure

Double-blind, Randomized, Sham-procedure-controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) in Chronic Heart Failure Due to LV Systolic Dysfunction (Ischemic or Nonischemic)

Researchers at UC San Diego are collaborating with Mesoblast, Inc. to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.

STATUS: Active / Enrolling

Contact: Betty Cabrera, MPH, CCRC (858) 534-5932 blcabrera@ucsd.edu
Trial Sponsor: Mesoblast

Chronic Lymphocytic Leukemia (CLL)

A Phase I Clinical Trial to Determine the Safety and Tolerability of UC-961 (Cirmtuzumab), an Anti-ROR1 Monoclonal Antibody, for the Treatment of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Who Are Ineligible for Chemotherapy

Researchers at UC San Diego are investigating the safety of the investigational agent, cirmtuzumabCirmtuzumab is a monoclonal antibody drug designed to attach to a protein, called ROR1, on the surface of chronic lymphocytic leukemia (CLL) cells to block cell growth and survival. ROR1 is rarely expressed on healthy cells so the idea is to preferentially get rid of the cancer cells.

STATUS: Active / Not Enrolling

Contact: Jesika Reiner (858) 822-5364 jreiner@ucsd.edu
Trial Sponsor: UC San Diego

 

A Phase 1b-2 Study of the ROR1-Targeting Monoclonal Antibody, Cirmtuzumab, and the Bruton Tyrosine Kinase Inhibitor, Ibrutinib, in Patients With B-Cell Lymphoid Malignancies

Researchers at UC San Diego are collaborating with Oncternal Therapeutics, Inc. to conduct the Phase I trial of the intravenous infusion of an antibody that targets cancer stem cells in people with relapsed or refractory chronic lymphocytic leukemia (CLL). 

STATUS: Active / Enrolling

Contact: Jesika Reiner (858) 822-5364 jreiner@ucsd.edu
Trial Sponsor: Oncternal Therapeutics

 

A Phase 1 Extension Study to Determine the Safety of UC-961 (Cirmtuzumab) at the Recommended Phase 2 Dose for Retreatment of Patients With Chronic Lymphocytic Leukemia Treated Previously With UC-961

Researchers at UC San Diego are investigating the safety of the investigational drug called cirmtuzumab when given for a duration of 6 to 12 months. Cirmtuzumab is a type of drug called a monoclonal antibody. This drug is designed to attach to a protein called ROR1 that is on the surface of chronic lymphocytic leukemia (CLL) cells. This blocks growth and survival of the CLL cells. ROR1 is rarely expressed on healthy cells so this drug should target the cancer cells.

STATUS: Active / Not Enrolling

Contact: Reilly Kidwell, BS, BA, CCRC (858) 534-4801 rkidwell@ucsd.edu
Trial Sponsor: UC San Diego 

Myelodysplastic Syndrome (MDS)

Collection of Bone Marrow, Peripheral Blood (PB), Epithelial Tissue, and Saliva Samples From Patients With Myelodysplastic Syndromes (MDS) to Identify MDS-Specific Antigens (MSA) for Use in Cellular Immunotherapy

Researchers at UC San Diego are collaborating with PersImmune, Inc. to collect the blood and marrow samples, and non-involved fibroblasts, that are required to identify the unique, personalized array of mutation-driven neoantigens that are expressed by the subject's MDS cells and to assess the feasibility of immunizing and expanding one or more of the patient's T cells ex vivo for investigation of their use as adoptive cellular immunotherapy.

STATUS: Active / Enrolling

Contact: Kimberly Aguilar (858) 534-5201 k1aguilar@ucsd.edu
Trial Sponsor: PersImmune, Inc.

 

A Phase 1 Clinical Trial of Personalized, Adoptive Cellular Immunotherapy Targeting Patient-specific Neoplastic Stem Cell Neoantigens (PACTN) in Patients With Myelodysplastic Syndromes (MDS)

Researchers at UC San Diego are collaborating with PersImmune, Inc to evaluate the safety of autologous T cells that have been immunized ex vivo with patient-specific MDS stem cell neoantigens in patients with MDS.

STATUS: Active / Enrolling

Contact: Tiffany Tanaka, MD (858) 534-5875 tntanaka@ucsd.edu
Trial Sponsor: PersImmune, Inc.

Spinal Cord Injury

A Phase 1, Open-label, Single-site, Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI

Researchers at UC San Diego are collaborating with Neuralstem, Inc. to conduct the safety trial of neural stem cell transplantation in paralysis patients due to traumatic injury within spinal cord segments T2-T12.

The transplantation involves the injection of neural stem cells into the spinal cord. This first-in-human clinical trial evaluates the safety of transplanting neural stem cells into the spine.

STATUS: Active / Enrolling

Contact: Dr. Ciacci's Research Group (844) 317-7836 alphastemcellclinic@ucsd.edu
Trial Sponsor: Neuralstem

 

A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury

Researchers at UC San Diego are collaborating with Asterias Biotherapeutics, Inc. to conduct the safety of cross sequential escalating doses of AST-OPC1 stem cell transplantation in patients with subacute cervical spinal cord injuries (SCI) due to injury within spinal cord segments.

The transplantation involves the injection of neural stem cells into the spinal cord. This first-in-human clinical trial evaluates the safety of transplanting neural stem cells into the spine.

STATUS: Active / Enrolling 

Contact: Dr. Ciacci's Research Group (844) 317-7836 alphastemcellclinic@ucsd.edu
Trial Sponsor: Asterias Biotherapeutics

 

A Long-term Follow-up Study of Subjects with Cervical Spinal Cord Injuries Who Received AST-OPC1 in Protocol AST-OPC1-01

STATUS: Active / Not Enrolling 

Contact: Dr. Ciacci's Research Group (844) 317-7836 alphastemcellclinic@ucsd.edu
Trial Sponsor: Asterias Biotherapeutics 

Type 1 Diabetes

A Prospective, Multicenter, Open-Label, First-in-Human Phase 1/2 Study With Two Cohorts to Evaluate the Safety, Tolerability, and Efficacy of Various Doses of VC-01™ Combination Product in Subjects With Type 1 Diabetes Mellitus

Researchers at UC San Diego are collaborating with ViaCyte to investigate if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01™ is an effective treatment for subjects with Type 1 Diabetes.

STATUS: Active / Enrolling

Contact: Betty Cabrera, MPH, CCRC (858) 534-5932 blcabrera@ucsd.edu
Trial Sponsor: ViaCyte

 

A One-Year, Multicenter, Observational, Follow-up Safety Study in Subjects Previously Implanted With VC-01™ Combination Product

Researchers at UC San Diego are collaborating with ViaCyte to evaluate the long-term safety in subjects previously implanted with VC-01™ combination product.

STATUS: Active / Enrolling

Contact: Betty Cabrera, MPH, CCRC (858) 534-5932 blcabrera@ucsd.edu
Trial Sponsor: ViaCyte

 

An Open-Label, First-In-Human Study Evaluating the Safety, Tolerability, and Efficacy of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness

Researchers at UC San Diego are collaborating with ViaCyte to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained safely for up to two years. It will also test if VC-02™ is an effective treatment for these subjects.

STATUS: Active / Enrolling

Contact: Betty Cabrera, MPH, CCRC (858) 534-5932 blcabrera@ucsd.edu
Trial Sponsor: ViaCyte

 

A One-year, Multicenter, Non-Interventional, Follow-up, Safety Study in Subjects Previously Implanted With VC-02 Combination Product

Researchers at UC San Diego are collaborating with ViaCyte to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for up to four months.

STATUS: Active / Enrolling 

Contact: Betty Cabrera, MPH, CCRC (858) 534-5932 blcabrera@ucsd.edu
Trial Sponsor: ViaCyte