StemCyte Reports Positive Phase IIa Trial Results for Cord Blood in Post-COVID Fatigue Treatment

In a notable advance, StemCyte has announced impressive results from a Phase IIa clinical trial evaluating the effectiveness of HPC, Cord Blood (HPC, CB) in treating Post-COVID Syndrome, commonly referred to as Long COVID. Conducted in Baldwin Park, California, the trial demonstrated substantial improvement in fatigue symptoms among participants treated with cord blood, as compared to those given a placebo.

The trial, approved by the U.S. FDA in 2020, was a randomized, controlled study involving 30 participants - 20 of whom received the cord blood treatment while the remaining 10 were administered a placebo. On December 13, 2024, the statistical results were unveiled, showcasing the trial’s success in meeting its primary and secondary endpoints.

The trial's primary safety objective was to assess treatment-emergent adverse events (TEAEs), and the results were promising. In the HPC, CB group, only 2 out of 20 participants experienced TEAEs, none of which were severe, and all were resolved within an hour. The incident rate stood at 10% for the treatment group compared to 20% in the placebo group, and no severe adverse events were reported, indicating a favorable safety and tolerance profile for the cord blood treatment.

Regarding efficacy, the trial utilized the Chalder Fatigue Questionnaire (CFQ-11) to evaluate fatigue severity among participants. The results showed remarkable improvements in fatigue symptoms, severity, and physical fatigue for those treated with cord blood. Specifically, the trial met its secondary efficacy endpoint with significant statistical improvements in fatigue at various intervals: weeks 6, 12, 18, and 26 post-treatment. At the conclusion of the trial, 85% of the cord blood group reported resolution of fatigue symptoms, compared to just 20% in the placebo group.

While the treatment showed substantial enhancements in physical fatigue severity, psychological fatigue did not demonstrate significant improvement, pointing to the treatment’s specific impact on physical symptoms of fatigue. Exploratory assessments, such as the PGI-S scale, reinforced these findings, showing notable improvements in fatigue symptoms among those receiving HPC, CB treatment.

Moreover, the trial included cognitive function assessments using the Montreal Cognitive Assessment (MoCA). Although the average scores showed some improvement post-treatment, the changes were not statistically significant when compared to the placebo group.

StemCyte’s product, REGENECYTE™, has been granted the prestigious Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA, acknowledging its potential to offer substantial benefits over existing treatments for serious ailments such as Long COVID. This designation enables StemCyte to collaborate closely with the FDA, potentially expediting the product's development and approval process.

With the success of the Phase IIa clinical trial, StemCyte is poised to accelerate the development of REGENECYTE™. The company is in active discussions with the FDA to advance to further clinical trials, underscoring the promising potential of HPC, CB in addressing the lingering symptoms of Post-COVID syndrome.

Additionally, StemCyte is exploring broader applications for its cord blood treatment. The trial's positive impact on reducing fatigue could extend to addressing chronic fatigue syndrome and potentially contribute to the global anti-aging market. As the demand for effective treatments for chronic conditions grows, StemCyte aims to commercialize REGENECYTE™ and seek international partnerships to expand its reach.

StemCyte continues to be a leader in regenerative medicine, committed to improving patient outcomes through innovative cord blood therapies. By advancing research and clinical applications, StemCyte strives to enhance the quality of life for patients worldwide.