Stage of Program: Clinical Stage Programs (2.0 and relevant 1.0 projects)


Clinical trial of directly vascularized islet cell replacement therapy for high-risk type 1 diabetes

ViaCyte is developing cell therapies to replace lost beta cells for people with type 1 diabetes (T1D). The therapies are derived from human embryonic stem cells, which are partially matured into becoming pancreatic tissues (the type destroyed in T1D). The cells are inserted into a small pouch that is transplanted under the patient’s skin. The […]

Tumor stem cell-targeted immunotherapy for metastatic melanoma –a randomized phase 3 clinical trial.

NeoStem, which later changed its name to Caladrius BioScience, ran a Phase 3 trial targeting cancer stem cells. These cells are believed to be able to survive chemotherapy and other cancer-targeting treatments, and can cause a relapse by enabling tumors to grow and spread. This approach used the patient’s own tumor cells to create a […]

Preclinical and clinical testing of a stem cell-based combination product for insulin-dependent diabetes

ViaCyte is developing cell therapies to replace lost pancreatic beta cells for people with type 1 diabetes (T1D). The therapies are derived from human embryonic stem cells, which are partially matured into becoming pancreatic tissues (the type destroyed in T1D). The cells are inserted into a small pouch that is transplanted under the patient’s skin. The […]

A Phase 1b/2a Study of the ROR1-Targeting Monoclonal Antibody, Cirmtuzumab, and the Bruton Tyrosine Kinase Inhibitor, Ibrutinib, in B-Cell Cancers

Cancer is a leading cause of death in California. Many cancers resist current therapies due to therapy-resistant cancer stem cells (CSCs). A team at UCSD is testing an antibody therapy called cirmtuzumab in a clinical trial study to treat a blood cancer, Chronic Lymphocytic Leukemia (CLL). The antibody recognizes and attaches to a protein on […]

A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Optimal Dose-Finding Study of DCC-UCB in Adults Receiving High Dose Chemotherapy for AML

Nohla Therapeutics is testing a hematopoietic stem cell and progenitor cell therapy called NLA101 to help patients suffering from neutropenia, a condition that leaves people susceptible to deadly infections, after receiving chemotherapy for acute myeloid leukemia (AML). The company is currently launching a Phase 2 trial to test this treatment in adult AML patients that […]

A Phase 3 Study Comparing the Utility of Human Acellular Vessels to Arteriovenous Fistula in Subjects with End-Stage Renal Disease (California Sites)

A phase I/II study of human placental hematopoietic stem cell derived natural killer cells (CYNK-001) for the treatment of adults with COVID-19

Therapeutic Candidate or Device Human placental hematopoietic stem cell derived natural killer cells (CYNK-001) Indication SARS-CoV-2 positive patients requiring hospital admission and have any 2 out of 3 symptoms: fever, cough, or positive disease-related chest x-ray. Therapeutic Mechanism CYNK-001 is allogenic, human placental hematopoietic stem cell-derived NK cells that express the dominant NK cells marker […]

Evaluation and Characterization of SARS-CoV-2 Antibody in Convalescent Volunteer Plasma Donors for Potential Therapeutic Use

Therapeutic Candidate or Device The therapeutic candidate is COVID-19 convalescent plasma (CCP) Indication The target indication is treatment of severe COVID-19 infection Therapeutic Mechanism Neutralizing antibodies are part of the humoral response of the adaptive immune system against viruses, and can be detected in plasma of convalescent individuals. Transfusion of COVID-19 convalescent plasma can provide […]

Mesenchymal Stromal Cells for ARDS (COVID positive and COVID negative)

Therapeutic Candidate or Device Novel testing of a cell based therapy (Mesenchymal Stromal Cells) for respiratory failure from ARDS. Indication COVID-19 positive or negative ARDS patients Therapeutic Mechanism It will hopefully improve oxygenation in ARDS patients and potentially decrease mortality. Unmet Medical Need There is an unmet need for more effective treatments for ARDS both […]

Phase 2 Study of Hematopoietic Stem Cell Gene Transfer Inducing Fetal Hemoglobin in Sickle Cell Disease

Therapeutic Candidate or Device Autologous CD34+ cells transduced ex vivo with the BCH_BB694 LCR(-HS4) bGp D12shmiR lentiviral vector Indication Sickle cell disease with severe phenotype. Therapeutic Mechanism Silencing of beta-sickle globin and induction of anti-sickling fetal hemoglobin Unmet Medical Need Sickle cell is a severe disease with protean manifestations. The only curative therapy is an […]