UCI Health and UCI Alpha Clinic have launched a Phase I/IIa clinical trial of a stem cell-derived therapy, IMM01-STEM, in patients with muscle atrophy that is associated with knee osteoarthritis.
The study will evaluate the tolerability and safety of IMM01-STEM in muscle atrophy patients.
It is claimed to be the first and only US clinical trial to study the stem cell-derived therapy in humans.
The Phase I/IIa clinical trial will enrol approximately 18 participants aged 50 years to 75 years.
It is sponsored by biotech company Immunis, which develops new therapies for age-related immune decline.
UCI Health orthopedic surgeon Dean Wang said: “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.”
IMM01-STEM, a secretome product, includes natural immunomodulators with potent cytoskeletal remodelling properties, which show the ability to address clinical requirements.
It is an injectable solution composed of proteins created by stem cells.
IMM01-STEM improved muscle mass and strength in ageing mouse models in pre-clinical studies, which were published last year.
The US Food and Drug Administration (FDA) approved the investigational new drug application for the clinical trial in August this year.
Immunis chief science officer Tom Lane said: “Muscle atrophy is a degenerative condition experienced by every ageing human but is exacerbated when coupled with immobilisation, as it is in patients with knee osteoarthritis.
“We hope to alleviate suffering, get better outcomes for knee osteoarthritis, and offer a new tool to combat immune-mediated symptoms of ageing in general.”