BALDWIN PARK, Calif., Dec. 19, 2024 /PRNewswire/ — StemCyte announced a significant breakthrough in its Phase IIa clinical trial of HPC, Cord Blood (HPC, CB) for treating Post-COVID Syndrome (Long COVID). This trial results demonstrated that cord blood significantly improved fatigue symptoms, with 85% of subjects in the cord blood group reporting complete relief from fatigue after treatment, compared to just 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.
Clinical Trial Background
In 2020, StemCyte received approval from the U.S. FDA to initiate a randomized, controlled, double-arm Phase IIa clinical trial evaluating the safety and efficacy of human umbilical cord blood in treating Post-COVID syndrome (NCT# NCT05682560). The trial was conducted in the United States and successfully recruited 30 participants. Of these, 20 participants received HPC, CB treatment, while 10 received a placebo. On December 13, 2024, the statistical data from the Phase IIa clinical trial were officially obtained.
Primary Safety Endpoint Achieved
The primary safety endpoint, based on the incidence of treatment-emergent adverse events (TEAEs), was successfully met. In the HPC, CB treatment group, 2 out of 20 participants experienced TEAEs, with no severe adverse events (SAEs), and all adverse events were resolved within 1 hour. 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%. Both TEAEs were unrelated to the treatment and were resolved with appropriate management. These results demonstrate that HPC, CB has good safety and tolerance in Post-COVID patients, with no severe adverse events that could impact the treatment.
Secondary Efficacy Endpoint Achieved (P<0.01)
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, CB treatment, significant improvements in fatigue symptoms were observed at week 6 (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 (2 out of 10 participants had a score <4).
- Fatigue Severity: Significant reductions in fatigue severity were observed at week 6 (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, CB treatment significantly improved physical fatigue severity at week 6 (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, CB and placebo groups (p>0.05), indicating that the treatment did not significantly impact psychological fatigue.
Exploratory Assessment Endpoints
- PGI-S Scale: 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), with statistical significance compared to the placebo group. These results were consistent with the CFQ-11 scale findings.
- Montreal Cognitive Assessment (MoCA): The MoCA scale, used to assess cognitive function, showed that the average MoCA score for the 30 participants was 24 before treatment. After cord blood treatment, the average score increased to 26 at week 12 and week 26. However, no significant statistical change was observed compared to the placebo group (p>0.05).
FDA RMAT Designation – A Key Advantage
StemCyte’s newly licensed HPC, Cord Blood product REGENECYTE™ has been granted the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation, a recognition given to therapies with the potential to offer significant benefits over existing treatments for serious or life-threatening conditions. 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™. As the first product globally to receive FDA approval for Phase II clinical trials using allogeneic umbilical cord blood stem cells for treating Post-COVID syndrome, REGENECYTE™ holds a unique position in the development of therapies for this condition.
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.
Expansion of RegeneCyte’s Application
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. As the U.S. remains the largest pharmaceutical market worldwide, the demand for effective treatments for chronic conditions like Post-COVID and fatigue is anticipated to rise. StemCyte aims to meet this growing demand by accelerating REGENECYTE’s commercialization and exploring international collaborations and licensing opportunities to expand its global footprint.
About StemCyte
StemCyte is a leader in regenerative medicine, dedicated to developing and delivering innovative therapies using cord blood. With a commitment to improving patient outcomes worldwide, StemCyte is at the forefront of exploring the potential of cord blood-derived therapies to address a variety of medical conditions. Through continuous research and clinical advancements, StemCyte aims to provide groundbreaking solutions that enhance the quality of life for patients around the globe.
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SOURCE StemCyte
