On December 16, StemCyte-KY announced that its subsidiary, StemCyte Inc. (U.S. StemCyte), had achieved clinically and statistically significant results in its U.S. Phase IIa clinical trial for the cell therapy drug REGENECYTE, aimed at treating long COVID syndrome.
The company stated that the Phase IIa trial for REGENECYTE, a randomized, controlled, two-arm study, was designed to evaluate the safety and tolerability of human umbilical cord blood infusion (REGENECYTE) in patients with long COVID. The secondary objective was to assess the drug's efficacy in alleviating fatigue symptoms in these patients.
The trial enrolled 30 long COVID patients who were randomly assigned to two groups: 20 in the treatment group and 10 in the placebo group. The trial was conducted under the approval of the U.S. FDA, with all 30 participants completing the study in the United States.
Results showed no serious adverse events (SAEs) among the 30 participants in both the REGENECYTE and placebo groups. The incidence rate of treatment-emergent adverse events (TEAEs) was 13.3% overall, with 10% in the treatment group and 20% in the placebo group, demonstrating the favorable safety profile of REGENECYTE. Furthermore, changes in Chalder Fatigue Scale (CFQ-11) scores at weeks 6, 12, 18, and 26 compared to baseline (screening period) indicated that REGENECYTE significantly improved fatigue symptoms compared to placebo.
StemCyte noted that REGENECYTE has been granted FDA designation as a Regenerative Medicine Advanced Therapy (RMAT). The company plans to proceed with the next phase of clinical trials based on the conclusions of its meetings with the FDA and is actively seeking co-development partners.
According to statistics from the World Health Organization (WHO) as of December 2024, the global number of confirmed COVID-19 cases has reached 776 million since the pandemic began in 2019. WHO's executive summary from April 8, 2024, estimates that approximately 10–20% of confirmed cases develop long COVID syndrome, equating to an estimated 78–155 million long COVID patients worldwide. Currently, no approved drugs are available globally for the treatment of long COVID syndrome.
Resource: 永笙長新冠症候群細胞新藥美國 Phase IIa 臨床試驗達標
