Project Objective: Clinical Trial, Phase 3
Cellular Immunotherapy for Induction of Immune Tolerance in HLA Matched Living Donor Kidney Transplant Recipients
Therapeutic Candidate or Device MDR-101 is cellular therapy consisting of kidney donor-derived CD34+ HSCs and CD3+ T-cells. Indication Maintenance of kidney allograft function after withdrawal of post-transplant immunosuppressant (IS) drugs in HLA matched kidney transplants recipients Therapeutic Mechanism Following infusion and engraftment of MDR-101, the progeny cells establish a state of mixed lympo-hematopoetic chimerism. This […]
A Phase 3, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy & Safety of Repeated Administrations of NurOwn® in Patients with ALS
Therapeutic Candidate or Device A cell therapy that delivers high levels of neurotrophic factors to the CNS Indication Amyotrophic lateral sclerosis (ALS) or Lou Gehrig Disease Therapeutic Mechanism The Cell therapy is aimed at providing high levels of neurotrophic factors directly to the CNS, to support the dying neurons Unmet Medical Need Amyotrophic lateral sclerosis […]
A Phase 3 Study Comparing the Utility of Human Acellular Vessels to Arteriovenous Fistula in Subjects with End-Stage Renal Disease (California Sites)
Therapeutic Candidate or Device Human Acellular Vessel (HAV) Indication Conduit for Vascular Access for Hemodialysis Therapeutic Mechanism Mechanism of action: the HAV is comprised of intact extracellular matrix constructed by human smooth muscle cells (SMC) in a biomimetic bioreactor system. The manufacturing process is designed to create a biologic matrix similar in protein composition and […]
A Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison with ePTFE Grafts as Conduits for Hemodialysis (HUMANITY)
Therapeutic Candidate or Device Human Acellular Vessel (HAV) Indication Conduit for Vascular Access for Hemodialysis Therapeutic Mechanism Mechanism of action: the HAV is comprised of intact extracellular matrix constructed by human smooth muscle cells (SMC) in a biomimetic bioreactor system. The manufacturing process is designed to create a biologic matrix similar in protein composition and […]
A Phase III randomized double-blind, controlled study of ICT 107 with maintenance temozolomide (TMZ) in newly diagnosed glioblastoma following resection and concomitant TMZ chemoradiotherapy
Therapeutic Candidate or Device Autologous dendritic cells pulsed with HLA-specific peptides derived from tumor-associated antigens Indication Newly diagnosed glioblastoma Therapeutic Mechanism Autologous dendritic cells charged with peptides derived from tumor-associated antigens drive the formation of T cells that specifically target cancer stem cells and tumor cells Unmet Medical Need Patients with glioblastoma, a rare brain […]
Tumor stem cell-targeted immunotherapy for metastatic melanoma –a randomized phase 3 clinical trial.
Therapeutic Candidate or Device Tumor stem cell-targeted immunotherapy. Indication Metastatic melanoma. Therapeutic Mechanism Destruction of host tumor stem cells by adaptive humoral cellular immunity will eradicate the origin of melanoma which will extend patient survival. Unmet Medical Need There is no effective treatment for metastatic melanoma. This treatment is the only one to target tumor […]
Alpha Clinic Network Expansion for Cell and Gene Therapies
The CIRM Alpha Clinic will expand capacities and workforce expertise to accelerate development, clinical testing, and dissemination of novel cell and gene therapies for a broad range of conditions that impact Californians across the lifespan and from diverse backgrounds and underserved communities. In 2020, Californians voted to increase their investment in regenerative medicine to address […]
A hub and spoke community model to equitably deliver regenerative medicine therapies to diverse populations across four California counties
Expand capacities to deliver novel cell and gene therapy treatments to diverse communities across four California Counties (REAL: ORange, RivErside, San BernArdino, and Los Angeles). We will conduct regenerative medicine trials, train a diverse workforce, and deliver novel network offerings. UCI ASCC REAL will accelerate the delivery of regenerative medicine to all Californians, emphasizing diversity, […]
UC San Diego Health CIRM Alpha Stem Cell Clinic
1. Strengthen and expand collaborations with ASCC Network partners with lead offerings 2. Improve access to clinical trials for diverse populations 3. Expand regenerative medicine clinical trial portfolio in major UCSD ASCC focus areas, including of cancer, metabolic disease, and neurological disease Innovative stem cell and gene therapy clinical trials can be implemented and accelerated […]
Expansion of the Alpha Stem Cell and Gene Therapy Clinic at UCLA
The ASCC provides infrastructure and operational support across the Network to drive novel stem cell therapies from bench to bedside. The ASCC will engage underserved communities in California to increase education and access to regenerative medicine trials and therapeutics. The ASCC will accelerate the clinical trial pipeline of novel regenerative medicine therapeutics and solidify California […]