Everyone ages and with aging comes a decline in immune system health. Compromised immune function contributes to degenerative conditions within the body, including muscle atrophy, which causes impaired mobility and compromises quality of life. Thus, treatments that can combat immune dysregulation may minimize the risk of immune-related diseases and promote a healthier human lifespan.
At Abundance360, Dr. Keirstead will share Immunis’ progress of an FDA-approved Phase 1/2a clinical trialwith a unique immunomodulatory stem cell secretome (STEM). Immunis is testing the safety and efficacy of STEM in patients with muscle atrophy associated with knee osteoarthritis. Pre-clinical studies published in GeroScience showed that STEM improved muscle mass and strength during disuse and recovery in aged mouse models. As there are no FDA-approved treatments to attenuate muscle loss and/or improve muscle regeneration, the results of the clinical trial will be monumental.
“It is an honor for Immunis to be highlighted as a critical breakthrough in our sector,” said Dr. Hans S. Keirstead, Chairman of Immunis, “And it is exciting to explore STEM’s efficacy in multiple manifestations of age-related and immune-related decline.”
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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
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), (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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