Hope Biosciences Reveals Topline Results of Cell Therapy Trial for Long COVID

Hope Biosciences Research Foundation (HBRF), a clinical research organization based in Sugar Land, Texas, has released the initial results from a Phase II study focused on evaluating their adipose-derived allogeneic mesenchymal stem cell therapy (HB-adMSCs) for patients dealing with Post-COVID-19 syndrome.

This randomized, placebo-controlled trial, designated NCT05126563, enrolled 79 participants—39 in the treatment group and 40 in the placebo group. Out of these, 34 individuals from the treatment group and 30 from the placebo group completed the study. The study spanned 26 weeks and required participants to receive four infusions of 200 million stem cells each, accumulating to a total of 800 million cells.

The primary measurement for the study was a visual analog scale (VAS) test for fatigue. According to the results, 68% of the participants in the treatment group displayed significant improvement (p=.0002) in their fatigue levels, while 63% of the placebo group also showed significant improvement (p=.001). It is worth noting that the differences between the treatment and placebo groups were not statistically significant. The therapy was found to be safe and well-tolerated in both groups. A more detailed analysis of the data is currently in progress.

Ridhima Vij, Ph.D., Clinical Research Scientist at HBRF, commented on the results, stating, "Our previous pilot study with 10 subjects demonstrated significant improvements in treating long-COVID symptoms using adipose-derived, autologous mesenchymal stem cell therapy. The current trial aligns with those findings, showing notable improvements in long-COVID symptoms. However, an unexpectedly high placebo effect was observed, which masked the treatment effects, with both groups showing significant improvements. This unprecedented placebo response indicates the need for further investigation."

HBRF is headquartered in Sugar Land, Texas, and is committed to exploring the impact of high-volume, sustained applications of adult stem cells on various diseases and conditions that currently lack a cure and affect a significant portion of the American population. The foundation’s research portfolio includes protocols for conditions like 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. Furthermore, HBRF has received FDA approval for more than 35 clinical protocols, which also cover lupus, chronic musculoskeletal pain, severe osteoarthritis, psoriatic arthritis, stroke, palliative care, and pancreatic cancer.

The support from The John S. Dunn Foundation played a crucial role in making this study possible. HBRF continues to push the boundaries of medical research, seeking innovative treatments for conditions that currently have limited therapeutic options.