Summary: StemCyte announced phase IIa clinical trial results for RegeneCyte (HPC, cord blood) in treating post-COVID syndrome, with 85% of patients experiencing complete relief from fatigue symptoms compared to 20% in the placebo group. The trial, involving 30 participants, met its primary and secondary endpoints, demonstrating both safety and efficacy. The treatment significantly reduced fatigue severity and improved physical fatigue while maintaining a favorable safety profile with no severe adverse events. StemCyte is now preparing for the next phase of trials and exploring broader applications, including chronic fatigue syndrome and the anti-aging market.
Key Takeaways:
- Significant Fatigue Improvement: In the trial, 85% of patients treated with RegeneCyte reported complete relief from fatigue symptoms compared to only 20% in the placebo group, with results showing statistical significance (p<0.01).
- Strong Safety Profile: The treatment demonstrated good safety and tolerance, with no severe adverse events reported, and a low incidence of treatment-emergent adverse events in both the treatment and placebo groups.
- Broader Applications: Beyond post-COVID syndrome, StemCyte is exploring the potential use of RegeneCyte for chronic fatigue syndrome and the anti-aging market, building on its demonstrated ability to reduce fatigue and frailty.
StemCyte announced that its phase IIa clinical trial of RegeneCyte (HPC, cord blood) for treating long-COVID significantly improved fatigue symptoms, with 85% of treated patients experiencing complete relief from fatigue, compared to 20% in the placebo group.
The clinical efficacy showed a statistically significant difference (p<0.01), meeting the trial’s efficacy endpoints. The overall safety and tolerance of the drug were also favorable.
In 2020, StemCyte received approval from the US Food and Drug Administration (FDA) to initiate a randomized, controlled, double-arm phase IIa clinical trial evaluating the safety and efficacy of the human umbilical cord blood in treating post-COVID syndrome.
The trial was conducted in the United States and recruited 30 participants. Of these, 20 participants received HPC, cord blood treatment, while 10 received a placebo.
The primary safety endpoint, based on the incidence of treatment-emergent adverse events (TEAEs), was successfully met. In the HPC, cord blood treatment group, two out of 20 participants experienced TEAEs, with no severe adverse events (SAEs), and all adverse events were resolved within one hour. The TEAE incidence rate for the HPC, cord blood group was 10%.
In the placebo group, two out of 10 participants experienced TEAEs, with no SAEs, resulting in a TEAE incidence rate of 20%. Both TEAEs were unrelated to the treatment and were resolved with appropriate management. These results demonstrate that HPC, cord blood has good safety and tolerance in post-COVID patients, with no severe adverse events that could impact the treatment.
Secondary Efficacy Endpoint Achieved
The Chalder Fatigue Questionnaire (CFQ-11) was used to assess the severity of fatigue symptoms. The results revealed significant improvements in fatigue symptoms, fatigue severity, and physical fatigue for post-COVID patients treated with cord blood.
The secondary efficacy endpoints were successfully met, with the following results:
- Fatigue Determination: All 30 participants had fatigue symptoms (CFQ-11 score ≥4) prior to treatment. After HPC, cord blood treatment, significant improvements in fatigue symptoms were observed at week six (p<0.001), week 12 (p<0.001), week 18 (p=0.002), and week 26 (p=0.007), with statistical significance compared to the placebo group. At the end of the trial (week 26), 85% of cord blood-treated patients had their fatigue symptoms resolved (17 out of 20 participants had a score <4), compared to only 20% in the placebo group (two out of 10 participants had a score <4).
- Fatigue Severity: Significant reductions in fatigue severity were observed at week six (p<0.001), week 12 (p<0.001), week 18 (p<0.001), and week 26 (p=0.004) in the HPC, CB group, compared to the placebo group.
- Physical Fatigue Severity: HPC, cord blood treatment significantly improved physical fatigue severity at week six (p<0.001), week 12 (p<0.001), week 18 (p<0.001), and week 26 (p=0.005), with statistical significance compared to the placebo group.
- Psychological Fatigue Severity: No significant improvement in psychological fatigue was observed between the HPC, cord blood and placebo groups (p>0.05), indicating that the treatment did not significantly impact psychological fatigue.
Phase IIa Clinical Trial Success and Next Steps
The HPC, cord blood phase IIa clinical trial results have demonstrated strong safety and efficacy, particularly in improving fatigue symptoms in post-COVID patients. Given the statistically significant improvements in fatigue severity (p<0.01), the treatment holds promise as a solution for addressing unmet medical needs in post-COVID care.
Building on these positive results, StemCyte is preparing to accelerate the development of RegeneCyte and is in rolling discussions with the FDA to move forward with the next phase of clinical trials.
In addition to its potential in treating post-COVID syndrome, StemCyte is exploring broader applications for RegeneCyte. The phase II trial’s positive impact on reducing patient frailty lays the foundation for expanding its use into chronic fatigue syndrome and the global anti-aging market.
ID 138232882 © Fizkes | Dreamstime.com
