The California Institute for Regenerative Medicine (CIRM) created the CIRM Alpha Stem Cell Clinic Network to help support access to approved clinical trials for Californians. The clinics are now part of the American Society of Hematology (ASH) Sickle Cell Disease (SCD) Collaborative Trials Network core program.
The Alpha Clinics are a network of top California medical centers that specialize in delivering stem cell clinical trials to patients. It includes five leading medical centers across California: City of Hope, University of California (UC) San Diego, UC Irvine & UC Los Angeles, UC Davis, and UC San Francisco.
The network
The ASH Research Collaborative SCD Clinical Trials Network aims to improve outcomes for individuals with Sickle Cell Disease by promoting innovation in therapy development and clinical trial research.
Like CIRM, the ASH Clinical Trials Network is a member of the National Heart, Lung and Blood Institute’s Cure Sickle Cell Initiative. This collaborative partnership aims to accelerate the development of genetic therapies to cure SCD within five to ten years.
“The key to finding a cure for this crippling disease—and finding it quickly—is to work together,” says Maria T. Millan, M.D., CIRM’s President and CEO. “That’s why we are delighted to be chosen as a core program for the ASH Sickle Cell Disease Clinical Trials Network. This partnership lets us share data and best practices to improve both our research and the clinical care we offer. We already have 23 clinical‑stage cell and gene therapy programs, including two trials for SCD, so we bring significant experience and expertise.”
Sickle Cell disease
Sickle cell disease is a life‑threatening blood disorder that affects 100,000 people in the U.S., mostly African Americans. A single genetic mutation causes red blood cells to form a “sickle” shape, blocking blood vessels and triggering severe pain, frequent hospitalizations, organ damage, and strokes.
According to Mark Walters, M.D., Director of UCSF Benioff Children’s Hospital Oakland’s Blood and Marrow Transplantation Program, current drugs only treat symptoms. “We hear a lot about a moonshot for curing cancer, but a moonshot for curing sickle cell disease should also be possible. SCD was the first genetic disease discovered—wouldn’t it be great if it became one of the first we can cure for everyone?”
The goal of the new clinical trial network is to better serve a historically underserved population by:
• Building connections and educational resources across trial sites to improve patient engagement and recruitment
• Standardizing resources to ensure efficiency and coordination
• Improving research staff training to enhance patient safety, trust, and study quality
The CIRM Alpha Clinics Network has demonstrated how to streamline and accelerate clinical trials. It has built tools to launch trials simultaneously at multiple sites, developed model nondisclosure agreements for faster contracting, created a system enabling one Institutional Review Board to approve a multi‑site trial, shared best practices across institutions, and assembled a database of more than 20 million Californians to boost recruitment.
An Executive Summary for the Western States Sickle Cell Disease Clinical Trials Network noted: “The ASCC provides a formidable clinical trial unit uniquely qualified to deliver the next generation of cell and gene therapy products.”s for SCD.”