Houston-area clinical research organization Hope Biosciences Research Foundation (HBRF) today shares topline results of a randomized, placebo-controlled Phase II study (NCT05126563) to evaluate Hope Biosciences’ adipose‑derived allogeneic mesenchymal stem cell therapy (HB-adMSCs) for patients with Post‑COVID‑19 syndrome.
The trial enrolled 79 participants, with 39 subjects in the treatment group and 40 in the placebo group; 34 participants completed the study from the treatment group, and 30 from the placebo group. The 26-week study mandated four infusions of 200 million stem cells, for a total of 800 million cells. The primary endpoint was a visual analog scale (VAS) test for fatigue, in which 68% of subjects in the treatment group showed significant improvement (p=.0002) and 63% of subjects in the placebo group showed significant improvement (p=.001). Differences between the treatment and placebo groups were not statistically significant. Treatment was safe and tolerable in both groups. Detailed analysis is now underway.
"Our previous pilot study (Adipose‑derived, autologous mesenchymal stem cell therapy for patients with post‑COVID‑19 syndrome: an intermediate‑size expanded access program) with N=10 subjects demonstrated highly significant improvements in treating the symptoms of patients with long-COVID,” explains Ridhima Vij, Ph.D., Clinical Research Scientist, HBRF. “Consistent with those findings, the current trial shows significant improvements in long-COVID symptoms. However, an unexpectedly high placebo effect was observed, masking the treatment effects, with both groups exhibiting significant improvements. This unprecedented placebo response suggests a need for further investigation.”
Headquartered in Sugar Land, Texas, HBRF is exploring the effects of high volume, sustained application of adult stem cells on diseases and conditions that currently have no cure and affect substantial portions of the American population. In addition to COVID and long-COVID protocols, HBRF has conducted and is pursuing work in central nervous system conditions such as Parkinson’s Disease, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), cerebral palsy, spinal cord injury, polyneuropathy, muscular dystrophy, drug-resistant epilepsy, and ataxia. To date HBRF has obtained FDA authorization for more than 35 clinical protocols in these and other conditions, including in lupus, chronic musculoskeletal pain, severe osteoarthritis, psoriatic arthritis, stroke, palliative care, and pancreatic cancer. The study announced in this release is made possible in part due to support from The John S. Dunn Foundation. Learn more at hopebio.org.
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