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


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 […]

University of California, San Francisco (UCSF) CIRM Alpha Stem Cell Clinic

We propose a cellular trial operation at UCSF that will focus on childhood hereditary hematological and immunologic disorders and in anti-inflammatory lung cellular therapies. This alpha clinic operation at UCSF will expand participation by California citizens in these novel clinical themes. The objective of this proposal from the Univ. of Calif., San Francisco is to […]

University of California, San Francisco (UCSF) CIRM Alpha Stem Cell Clinic

We propose a cellular trial operation at UCSF that will focus on childhood hereditary hematological and immunologic disorders and in anti-inflammatory lung cellular therapies. This alpha clinic operation at UCSF will expand participation by California citizens in these novel clinical themes. The objective of this proposal from the Univ. of Calif., San Francisco is to […]

Alpha Stem Cell Clinic for Northern and Central California

The UC Davis Alpha Clinic will provide pivotal resources to assist in the approval & conducting of stem cell/regenerative medicine clinical trials. A centralized space & personnel to administer the therapies to patients in the UCD 33-county catchment region (~6 million people in Northern/Central CA) Thanks to infrastructure & funding provided by CIRM, stem cell/regenerative […]

A Translating Center designed to expedite the development and delivery of high quality stem cell therapies to patients

A successful partnership, resulting in the creation of a Translating Center recognized as the leader in providing end-to-end preclinical development services (preclinical research, CMC, regulatory) to accelerate the availability of stem cell treatments to patients with unmet medical needs. The proposed Translating Center will benefit the lives of patients in CA with serious unmet medical […]

An Accelerating Center designed to expedite the development and delivery of high quality stem cell therapies to patients

A successful partnership, resulting in the creation of an Accelerating Center recognized as the leader in providing end-to-end clinical development services (regulatory, clinical, data management) to accelerate the availability of stem cell treatments to patients with unmet medical needs. The proposed collaborative research will benefit the lives of patients in CA with serious unmet medical […]

A Phase 1 Study of FT819 in Participants with Moderate to Severe Active Systemic Lupus Erythematosus

Therapeutic Candidate or Device iPSC-derived CD19 CAR T cell therapy Indication Systemic Lupus Erythematosus Therapeutic Mechanism Depletion of CD19+ B cells and plasmablasts Unmet Medical Need Potential for drug-free remission and reset of the immune system Project Objective Phase 1 trial completed Major Proposed Activities Site Activation and Patient Enrollment Clinical Trial Data Monitoring, Database […]

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 […]

Phase 1 Study of Autologous E-SYNC T Cells in Adult Participants with EGFRvIII+ Glioblastoma

Therapeutic Candidate or Device Human T cells transduced with a lentiviral vector encoding anti-EGFRvIII synNotch-primed anti-EphA2/IL-13Rα2 chimeric antigen receptor. Indication Patients with MGMT unmethylated newly diagnosed GBM (Cohort 1), and patients for whom re-resection of recurrent GBM (Cohort 2). Therapeutic Mechanism In our proposed system, the first antigen EGFRvIII, which is expressed exclusively but heterogeneously […]

Phase 1/2a Dose Escalation Study of ANPD001 in Sporadic Parkinson Disease

Therapeutic Candidate or Device Autologous stem cell-derived dopaminergic neuron replacement therapy. Indication Parkinson’s disease Therapeutic Mechanism The investigational cell therapy product is being studied as an autologous neuron replacement for Parkinson’s disease. Unmet Medical Need PD is a neurodegenerative disorder, affecting 1+ million people in the US. PD causes loss of dopamine (DA) neurons in […]

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