Every human experiences a decline in immune system health as they age, which contributes to degenerative conditions throughout the body, including muscle atrophy. Age-related muscle atrophy (sarcopenia) and muscle wasting from disuse or disease significantly decreases quality of life. The open label dose escalation study will enroll up to 18 patients to assess the safety and tolerability of IMM01-STEM in older participants with muscle atrophy related to knee osteoarthritis (KOA), a condition which combines disuse, age and disease-related muscle atrophy. KOA is a local and systemic inflammatory disease that is a leading cause of disability among older adults. Muscle atrophy is the primary underlying cause of this impaired mobility, with muscle dysfunction expediting cartilage deterioration in patients.
“Immunis is excited to be entering human clinical testing with an entirely new category of treatment, an immunomodulatory secretome product,” said Dr. Tom Lane, Chief Science Officer of Immunis. “The secretome is all natural, all human and represents a perfectly balanced set of immune modulators in naturally occurring relevant physiological concentrations.”
There are currently no FDA-approved treatments to attenuate muscle loss and/or improve muscle regeneration. In pre-clinical studies, IMM01-STEM improved muscle mass and strength during disuse and recovery in aged mouse models. The results were described in a 2022 GeroScience publication entitled “Reversal of deficits in aged skeletal muscle during disuse and recovery in response to treatment with a secretome product derived from partially differentiated human pluripotent stem cells.”
About Immunis Inc.
Immunis is a private biotechnology company developing a novel immunomodulatory secretome product for the 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. For additional information about Immunis’ IMM01-STEM Phase 1/2a trial please visit: www.immunisbiomedical.com
About Alpha Stem Cell Clinics
Alpha Stem Cell Clinics is a network of top medical centers in California that specializes in stem cell clinical trials. The Network is successful in providing accelerated delivery of treatments to their patients through strong partnerships between patients, medical providers and clinical trial sponsors. These partnerships leverage industry and academic resources to develop high-quality research and innovative stem cell therapies for patients. For additional information about Alpha Stem Cell Clinics please visit: www.cirm.ca.gov
Immunis’ FDA-awarded Phase 1/2a clinical trial is an open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in elderly participants with muscle atrophy associated with knee osteoarthritis. Up to 18 patients will be enrolled in the trial and randomly assigned to an IMM01-STEM dose cohort. Treatment will be administered in the form of intramuscular injections twice a week for four weeks (8 injections total). Male or female patients are eligible for the study if they satisfy the following criteria: (1) 50 to 75 years of age at the time of signing the informed consent, (2) have a grade 2 or 3 knee osteoarthritis as defined by Kellgren-Lawrence analyses, (3) have quadricep weakness (<7.5N/kg/m2), (4) can ambulate >50 feet unassisted, (5) are negative for human immunodeficiency virus, hepatitis B surface antigen (HBsAg), and hepatitis C at the Screening Visit and (6) have a body mass index (BMI) of <40kg/m2. For additional information about Immunis’ trial participant qualifications, please visit: www.immunisbiomedical.com
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