Innovative Treatment for Post-COVID Syndrome: A Clinical Breakthrough

As of July 2024, over 775 million people worldwide have confirmed cases of COVID-19, according to the World Health Organization. While the majority recover fully, studies reveal that 10 to 20% of these individuals experience persistent symptoms, known as post-COVID syndrome (long COVID). This condition affects multiple organ systems, with fatigue being the most frequently reported and burdensome symptom by 87% of patients. Post-COVID syndrome significantly impairs daily functioning and quality of life, highlighting the urgent need for effective treatments.

RegeneCyte® (HPC, cord blood, hUCB), developed by StemCyte Inc., is a pioneering regenerative medicine therapy (RMT). It is rich in monocytes, lymphocytes, stem cells (CD34+ cells), and progenitor cells. The safe and effective use of hUCB transplantation in treating various conditions, from hematological malignancies to neurological disorders, positions it as a promising candidate for addressing post-COVID syndrome, particularly in alleviating fatigue.

Our phase IIa clinical trial (NCT#05682560) investigates the safety, tolerability, and efficacy of RegeneCyte® for post-COVID syndrome. The randomized, single-blind, placebo-controlled study involves 30 subjects aged 18 to 65 years, with persistent post-COVID symptoms for over 6 months but not exceeding 18 months. Subjects are randomized in a 2:1 ratio between the treatment and placebo arms. Fatigue severity is assessed using the Chalder Fatigue Scale (CFQ-11) as the effectiveness endpoint. Twenty subjects in the treatment arm receive three intravenous doses of RegeneCyte® every three weeks, with follow-up over 20 weeks. Each dose contains at least 1 × 10^7 total nucleated cells (TNC)/kg, with a cumulative dose of at least 3 × 10^7 TNC/kg per subject. This is the first clinical trial which use three units of HPC in one subject in the past decades.

Preliminary data from the first 15 subjects show no trends in the changes of clinical safety laboratory parameters between the RegeneCyte® and placebo groups. Efficacy results at week 12 reveal that 90% of RegeneCyte®-treated subjects are classified as “non-fatigue” cases, compared to 100% in the placebo group remaining “fatigue” cases. Furthermore, 80% of RegeneCyte®-treated subjects show improvement to a “normal” level of physical fatigue, whereas all placebo recipients remain at the “fatigue” level. These findings demonstrate that RegeneCyte® is safe, well-tolerated, and significantly improves fatigue symptoms in post-COVID syndrome patients.

In conclusion, RegeneCyte®, a first-in-class regenerative medicine therapy, shows significant potential in treating post-COVID syndrome. The clinical evidence of profound fatigue reduction and a high safety profile underscores its therapeutic promise. RegeneCyte® infusion presents a viable treatment option for post-COVID syndrome, addressing unmet medical needs and expanding the scope of RegeneCyte® applications.

No relevant conflicts of interest to declare.