StemCyte has officially announced a significant breakthrough in its Phase IIa clinical trial of HPC, Cord Blood (HPC, CB) for treating Post-COVID Syndrome (Long COVID).
According to certain reports, the stated study would go on to showcase 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. More on the same would reveal how clinical efficacy here showed a statistically significant difference (p<0.01), meeting the trial’s efficacy endpoints. Beyond that, the overall safety and tolerance of the drug were also favorable.
Markedly enough, in HPC, CB treatment group, 2 out of 20 participants experienced TEAEs, and there were no severe adverse events (SAEs). All adverse events were also 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.
Talk about the whole exercise on a slightly deeper level, we ought to mention how StemCyte’s study used Chalder Fatigue Questionnaire (CFQ-11) to evaluate the severity of fatigue symptoms. As for the results, they revealed significant improvements in fatigue symptoms, fatigue severity, and physical fatigue for post-COVID patients treated with cord blood. The secondary efficacy endpoints were also successfully met.
A more specific lowdown of those results would begin from the therapeutics’ performance in fatigue determination. Here, going by the available details, all 30 participants had fatigue symptoms (CFQ-11 score ≥4) prior to treatment. However, 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. By the end of this trial, an estimated 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).
Next up, we have the aspect of fatigue severity. You see, SystemCyte’s study would go on to show substantial reductions in fatigue severity 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.
Moving on to physical fatigue severity, it informs us on the way 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). Beyond physical, the study also covered psychological fatigue severity. In essence, 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.
Turning our attention towards the trial’s exploratory assessment endpoints, it included PGI-S scale, which was used to assess changes in fatigue symptoms. This assessment 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). For better understanding, these results were consistent with the CFQ-11 scale findings.
Another exploratory assessment endpoint in play here would be Montreal Cognitive Assessment (MoCA). Basically, the MoCA scale was used to assess cognitive function, showing an average MoCA score of 24 before treatment. After cord blood treatment, the average score increased to 26 at week 12 and week 26. Having said so, no significant statistical change was observed compared to the placebo group (p>0.05).
Among other things, we must mention that the development in question delivers a rather interesting follow-up to SystemCyte securing FDA’s approval, back in 2020, for conducting randomized, controlled, double-arm Phase IIa clinical trial to evaluate the safety and efficacy of human umbilical cord blood in treating Post-COVID syndrome (NCT# NCT05682560). From the 30 surveyed participants, 20 participants received HPC, CB treatment, while 10 received a placebo.
