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UCI opens clinical trial of stem cell-derived therapy for knee arthritis

Early-phase study is first in the U.S.

November 29, 2022

Irvine, Calif. – UCI Health and UCI Alpha Clinic have launched the first U.S. clinical trial to test the safety and tolerability of IMM01-STEM in patients with knee osteoarthritis to prevent muscle atrophy.

Up to 18 patients ranging in age from 50 to 75 will be enrolled in the phase 1/2a clinical trial sponsored by Immunis Inc., a biotech company developing novel treatments for age-related immune decline. 

People with knee osteoarthritis tend to reduce their physical exercise because of pain. Muscles in the leg help support the knee joint, so keeping them strong and healthy can limit the symptoms of osteoarthritis. However, when exercise causes pain, it can be difficult for people to maintain or rebuild the muscle strength needed to prevent worsening knee arthritis.

“Conducting clinical trials to validate whether stem cell-derived treatments might be effective for patients suffering from muscle atrophy is a key part of our mission,” said UCI Health orthopedic surgeon Dean Wang, MD, the trial's principal investigator and associate professor of orthopaedics at the UCI School of Medicine. 

“IMM01-STEM is an injectable solution composed of proteins that were created by stem cells," Wang said. "It has been shown to increase muscle mass and strength in animal studies.”

The trial is the first to study this therapy in humans.

“Muscle atrophy is a degenerative condition experienced by every aging human but is exacerbated when coupled with immobilization, as it is in patients with knee osteoarthritis,” said Tom Lane, PhD, chief science officer of Immunis. “We hope to alleviate suffering, get better outcomes for knee osteoarthritis and offer a new tool to combat immune-mediated symptoms of aging in general.”

According to Immunis, IMM01-STEM is a one-of-a-kind secretome product comprised of natural immunomodulators with potent cytoskeletal remodeling properties that demonstrates the ability to address these clinical needs. In pre-clinical studies published last year, it improved muscle mass and strength during disuse and recovery in aging mouse models. In August, the U.S. Food and Drug Administration approved an investigational new drug application for the trial, which is now open at UCI.

“We are excited to have reached this clinical milestone that allows us to begin exploring the potential impact of IMM01-STEM in the treatment of an otherwise untreatable disorder,” said Erin Curry, director of medical affairs at Immunis.

To learn more about the IMM01-STEM trial, please view the participant information flyer ›

You may also contact the UCI Alpha Clinic at stemcell@uci.edu or call 949-824-3990. Learn more about other open clinical trials › 

Immunis Inc. is a private biotechnology company that is developing a novel immunomodulatory secretome product for various manifestations of age and disease-related immune decline. The STEM product line leverages Immunis’ leading-edge capabilities in stem cell technologies to deliver a product of all natural, all human immune modulators in their natural relative physiological concentrations. Learn more about Immunis at www.immunisbiomedical.com

The UCI Alpha Clinic is the clinical trial arm of the UCI Sue & Bill Gross Stem Cell Research Center and part of a network of the leading medical centers funded by the California Institute for Regenerative Medicine. It specializes in delivering leading-edge stem cell clinical trials and gene therapy to patients, and it seeks to accelerate the development of new treatments through partnerships with patients, medical providers and clinical trial sponsors. Visit stemcell.uci.edu to learn more about our regenerative medicine research.

UCI Health is the clinical enterprise of the University of California, Irvine, and the only academic health system in Orange County. Patients can access UCI Health at primary and specialty care offices across Orange County and at its main campus, UCI Medical Center in Orange, Calif. The 459-bed, acute care hospital, listed among America’s Best Hospitals by U.S. News & World Report for 22 consecutive years, provides tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health and rehabilitation services. UCI Medical Center is home to Orange County’s only National Cancer Institute-designated comprehensive cancer centerhigh-risk perinatal/neonatal program and American College of Surgeons-verified Level I adult and Level II pediatric trauma center and regional burn center. UCI Health serves a region of nearly 4 million people in Orange County, western Riverside County and southeast Los Angeles County. Follow us on FacebookInstagramLinkedIn and Twitter.