StemCyte, a regenerative medicine company, has announced positive results from its Phase IIa clinical trial of HPC, Cord Blood (HPC, CB) for treating Post-COVID syndrome (Long COVID). The trial demonstrated that cord blood significantly improved fatigue symptoms, with a statistically significant difference compared to placebo (p<0.01). The company's product, Regenecyte, has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, potentially accelerating its path to market.
The Phase IIa trial (NCT# NCT05682560), initiated in 2020, was a randomized, controlled, double-arm study conducted in the United States. It enrolled 30 participants, with 20 receiving HPC, CB treatment and 10 receiving a placebo. The primary endpoint focused on safety, while secondary endpoints assessed efficacy in improving fatigue symptoms.
Safety and Efficacy Outcomes
The trial successfully met its primary safety endpoint. In the HPC, CB treatment group, 2 out of 20 participants experienced treatment-emergent adverse events (TEAEs), with no severe adverse events (SAEs). The TEAE incidence rate for the HPC, CB group was 10%. In the placebo group, 2 out of 10 participants experienced TEAEs, with no SAEs, resulting in a TEAE incidence rate of 20%. All adverse events were resolved, demonstrating good safety and tolerance of HPC, CB in Post-COVID patients.
Significant improvements in fatigue symptoms were observed in the cord blood group. Using the Chalder Fatigue Questionnaire (CFQ-11), researchers found statistically significant improvements at week 6 (p<0.001), week 12 (p<0.001), week 18 (p=0.002), and week 26 (p=0.007) compared to the placebo group. At the end of the trial (week 26), 85% of cord blood-treated patients had their fatigue symptoms resolved, compared to only 20% in the placebo group.
Additional Assessments
The PGI-S scale, used to assess changes in fatigue symptoms, showed significant improvements in the HPC, CB group at week 12 (p=0.001), week 18 (p=0.004), and week 26 (p=0.007), consistent with the CFQ-11 scale findings. The Montreal Cognitive Assessment (MoCA) showed an increase in average score after cord blood treatment, but no significant statistical change compared to the placebo group (p>0.05).
RMAT Designation and Future Plans
StemCyte's Regenecyte has been granted the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation. This designation allows StemCyte to work closely with the FDA, expediting the development process and facilitating priority review and potential accelerated approval pathways for Regenecyte. StemCyte is preparing to accelerate the development of Regenecyte and is in discussions with the FDA to move forward with the next phase of clinical trials.
StemCyte is also exploring broader applications for Regenecyte, including chronic fatigue syndrome and the anti-aging market.
