Project Objective: Clinical Trial, Phase 2
Alpha Stem Cell Clinic for Northern and Central California
The UC Davis Alpha Stem Cell Clinic has improved operations and streamlined processes for conducting stem cell and gene therapy clinical trials. The current proposal will accelerate and expand our activities with a focus on reaching the underserved populations in our expansive catchment area. The UC Davis Alpha Stem Cell Clinic (ASCC) recognizes the importance […]
The City of Hope Alpha Clinic: A roadmap for equitable and inclusive access to regenerative medicine therapies for all Californians
City of Hope has long developed groundbreaking therapies, and building on that success we want to democratize cancer care by bringing therapies to patients rather than making them come to us. This will ensure that all Californians have the same access to cutting-edge care. The Alpha Clinic Network is committed to ensuring equitable access to […]
A comprehensive stem cell and gene therapy clinic to advance new therapies for a diverse patient population in California
We aim to markedly expand access of all Californians to outstanding cell and gene therapy trials for multiple conditions with unmet treatment needs. We will also contribute with excellence to the other network sites in advancing all aspects of regenerative medicine. As an ASCC, we will help advance the field for multiple diseases with unmet […]
University of California, San Francisco (UCSF) Alpha Stem Cell Clinic (ASCC)
We propose cell and gene therapy trial infrastructure that will focus on hereditary hematological and immunologic disorders and on anti-inflammatory lung disorders. This alpha stem cell clinic operation at UCSF will expand access to these novel cell and gene therapies to California citizens . The objective of this proposal from the Univ. of Calif., San […]
The Stanford Alpha Stem Cell Clinic
Our project objective is to develop a sustainable infrastructure and become a Northern California hub for stem cell therapies, thus both reducing current patient burden and increasing access to this treatment modality for patients with unmet medical needs. A major roadblock in stem cell therapies is confirming their efficacy in patients. The Alpha Clinic will […]
A phase 1/2 study to evaluate a bispecific CD19/CD20-directed CAR T cell, in refractory lupus nephritis and systemic lupus erythematosus
Therapeutic Candidate or Device IMPT-514 is an autologous T-cell product genetically modified to express a chimeric antigen receptor targeting CD19 and CD20 Indication Active, refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE) Therapeutic Mechanism Targeted depletion of pathogenic autoantibody-secreting B cells as well as CD20+ T cells by a bispecific CD19/CD20 -directed CAR T […]
A Phase 2b Study of the Efficacy of a Novel Pro-Neurogenesis/Pro-Plasticity Drug for Bipolar Depression Using a Precision Psychiatry Approach
Therapeutic Candidate or Device ALTO-100 Indication Bipolar depression (I or II) Therapeutic Mechanism ALTO-100 increased hippocampal neurogenesis and neuroplasticity. Its effects are mediated by signaling through the brain derived neurotrophic factor (BDNF) pathway. Unmet Medical Need Bipolar depression is a severe, life-long disorder with high burden of illness and risk of suicide. The only approved […]
A Phase 2 Study Evaluating the Efficacy and Safety of IV Administered rAAV9 Vector Containing RP-A501 in Male Patients with Danon Disease
Therapeutic Candidate or Device RP-A501, a recombinant Adeno-Associated Virus Serotype 9 containing the LAMP2B transgene Indication Danon Disease Therapeutic Mechanism The proposed product, RP-A501, is an in vivo gene therapy consisting of a recombinant AAV9 vector engineered with genetic elements designed to ensure consistent delivery and expression of the LAMP2B transgene. The therapy is administered […]
The CuRe Trial: Cellular Therapy for In Utero Repair of Myelomeningocele
Therapeutic Candidate or Device Allogeneic Placenta-derived Mesenchymal Stem Cells Seeded on Cook Biodesign® Dural Graft Extracellular Matrix (PMSC-ECM) Indication Myelomeningocele (MMC) -or Spina Bifida -diagnosed prenatally Therapeutic Mechanism Placenta-derived mesenchymal stem cells (PMSCs) act by a paracrine mechanism, secreting a variety of growth factors, cytokines, and extracellular vesicles. This secretory profile is unique to PMSCs […]
A Phase 2b, Randomized, Assessor-Masked Clinical Trial to Assess the Safety and Efficacy of the CPCB-RPE1 Implant in Subjects with Geographic Atrophy
Therapeutic Candidate or Device A patch comprised of a layer of stem cell-derived retinal pigmented epithelial (RPE) cells on a supporting matrix that is implanted under the retina Indication Geographic atrophy, the late-stage form of age-related macular degeneration Therapeutic Mechanism The healthy RPE cells on the implant replace dying RPE cells in the eye that […]