Almost every day, we hear new reports from the thousands of regenerative medicine clinical trials globally sponsored by hundreds of companies and academic researchers.
The California Institute for Regenerative Medicine (CIRM) leads in this space, supporting some of the most advanced cell and gene therapy clinical trials for a variety of unmet medical needs. With all this activity, it’s easy to forget that only a handful of clinical trials were underway just seven years ago.
A New System for Delivering Treatments
In 2015, CIRM’s leadership recognized that a wave of new regenerative medicine clinical trials was approaching. But one major concern remained: existing clinical delivery systems had limited experience and capacity to manage these complex trials. Cell and gene therapy treatments require new systems for manufacturing, processing, and delivery.
Anticipating the need for greater clinical bandwidth, CIRM funded a network of California medical centers dedicated to supporting regenerative medicine trials. This network became the Alpha Clinics Network.
Since 2015, the Alpha Clinics Network has grown to include six academic medical centers across California. The network has treated more than 1,000 patients in over 100 clinical trials. Companies and academic researchers often seek to bring their work to California specifically to access the Alpha Clinics. Sponsors consistently cite the network’s strengths—manufacturing expertise, process development, delivery capabilities, and regulatory compliance. One sponsor summarized it simply: the Alpha Clinics have “fewer protocol deviations.”
Expanding the Alpha Clinics Network
As we enter 2022 with CIRM’s new five-year strategic plan, a major goal is to build a broad network of medical centers that can support diverse participation in clinical trials.
As a first step, CIRM announced $80 million to expand the Alpha Clinics Network. This investment will grow the network from six to as many as ten medical centers. Scale matters because as clinical trials increase, coordination and workload sharing must grow as well. Alpha Clinic sites already collaborate on individual trials, and an expanded network will support more trials running simultaneously.
The Expansion Awards will also broaden the network’s capabilities to meet emerging needs in the field. Sites plan to incorporate new research platforms, including advanced genomic tools that improve diagnosis and treatment.
CIRM remains committed to funding therapies for neurological diseases. We expect network sites to develop advanced systems to deliver treatments and evaluate their effectiveness, as well as new training programs to address the growing workforce needs in regenerative medicine.
In 2015, CIRM launched the Alpha Clinics Network, positioning California as a leader in regenerative medicine clinical trials. In 2022, we will expand the network to deliver transformative treatments to diverse communities in California and beyond. The network will achieve this by extending its geographic reach, advancing research platforms and technologies, and training the next generation of researchers to deliver patient‑ready therapies.