CIRM invests $26 million in clinical-stage research, including for bipolar disorder and depression 

/ California Institute for Regenerative Medicine (CIRM)
Stock image of a dual tone brain by Getty Images

The California Institute for Regenerative Medicine (CIRM) awarded nearly $26 million to support clinical research, funding projects that included treatments for bipolar disorder and depression. The awards included funding for advancing a spinal cord injury therapy.

These awards support four projects in CIRM’s clinical program. Each backs eligible stem cell and gene therapy efforts through every stage of clinical trial development.

CIRM also approved a concept proposal for the Community Care Centers of Excellence (CCCE), a new model designed to expand clinical trial access in diverse communities across California.

The clinical awards approved at CIRM’s January ICOC meeting include:

Approved Awards

Application #  Program Title  Principal Investigator/Institution Amount  
CLIN1-14840 Prevention of GvHD in patients receiving HLA mismatched related or unrelated allogeneic HSCT for the treatment of hematologic malignancies de Vries, David – Tr1X Inc $4,000,000 
CLIN2-15085 Personalized antisense oligonucleotide therapy for rare pediatric genetic disease: 
SCN2A 		Kim-McManus, Olivia – UCSD $985,713 
CLIN2-15395 A Phase 2b Study of the Efficacy of a Novel Pro-Neurogenesis/Pro-Plasticity Drug for Bipolar Depression Using a Precision Psychiatry Approach Etkin, Amit – Alto Neuroscience $15,000,000 
CLIN1-15450 Human Embryonic Stem Cell-Derived Neural Stem Cells for Severe Spinal Cord Injury (SCI) Tuszynski, Mark – UCSD $6,000,000 

Improving the Treatment Landscape for Bipolar Depression  

A $15 million award to Alto Neuroscience and its President and CEO, Amit Etkin, MD, PhD, will support a Phase 2b trial testing a new therapeutic treatment for bipolar depression (I or II), a condition affecting 4.4% of U.S. adults.

The drug targets neural progenitor cells to boost the brain’s ability to create new neurons and strengthen connections in the hippocampus, a region tied to bipolar depression.

Bipolar depression is a severe, lifelong psychiatric disorder with a high burden of illness and an increased risk of suicide.

“Given the prevalence of bipolar depression and the high unmet medical needs of those facing this challenging disorder, this potential new therapy could expand treatment options for the hundreds of thousands of Californians affected by this chronic neuropsychiatric disease,” said Abla Creasey, PhD, Vice President of Therapeutic Development at CIRM.

Unlike current treatments that rely on antipsychotics and mood stabilizers, this small‑molecule drug may offer better tolerability and includes a diagnostic tool to identify patients most likely to benefit.

Using Stem Cells to Restore Function After Spinal Cord Injury

CIRM added a $6 million award to its clinical program for Mark Tuszynski, MD, PhD, at the University of California San Diego (UCSD) to study human embryonic stem cells as a treatment for severe spinal cord injury (SCI).

The proposed therapy implants neural stem cells at the injury site to regenerate and repair damaged axons.

SCI affects more than half a million Americans and causes long‑term disability, chronic neuropathic pain, and high healthcare costs.

“This potential therapy represents a unique and forward‑looking approach to treating severe spinal cord injury and underscores CIRM’s commitment to advancing groundbreaking solutions to transform patients’ lives,” said Dr. Creasey.

Improving Access to Treatments Across California

CIRM also approved a plan for the Community Care Centers of Excellence (CCCEs), which includes up to $60 million in projected awards.

Proposition 14, the California Stem Cell Research, Treatments, and Cures Initiative of 2020, requires creation of the CCCE Program to expand statewide access to clinical trials, treatments, and therapies developed through CIRM‑funded research.

The CCCEs will serve as hubs to increase access to clinical trials, regenerative medicine treatments, and CIRM education and training programs. The program will build community partnerships to engage populations that stand to benefit.

A key goal is to ensure equitable access for communities that currently have limited opportunities to participate in clinical research and treatment.

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