Hemostemix Phase II Trial: Positive Outcomes in CLI Treatment Published

Hemostemix, a leading autologous stem cell therapy company, has recently reported the successful results of its Phase II randomized clinical trial. The trial, which focused on patients suffering from critical limb ischemia (CLI) with ulcers, demonstrated significant improvements in wound healing, amputation rates, and mortality for those treated with Hemostemix's proprietary stem cell therapy, ACP-01.

In the study, a total of 67 patients were divided into two groups: one receiving ACP-01 treatment and the other a placebo. Among them, 21 patients with ulcers in the treatment group experienced a remarkable reduction in ulcer size from an average of 1.46 cm² to 0.48 mm² within just three months, a statistically significant decrease (p = 0.01). In contrast, the placebo group showed no significant change in ulcer size (p < 0.54).

The treatment's safety was further underscored by the absence of treatment-related complications after one year. The amputation rate in the ACP-01 group was a mere 4.8%, with only one amputation occurring, compared to 25% in the placebo group. Similarly, the mortality rate in the treatment group was 4.8%, with one death, while the placebo group had one death, representing a 12.5% mortality rate.

Dr. Fraser Henderson, Chief Medical Officer at Hemostemix, highlighted the significance of these results, stating that the ACP-01 treatment group showed a substantial decrease in ulcer size, lower amputation rate, and lower mortality rate at 12 months. The one-year death rate of 4.8% in the ACP-01 treated patients was notably lower than the 15%-20% rate reported in literature within six months of a CLI diagnosis. The amputation rate also compared favorably with literature reports ranging from 10% to 40% per year.

Thomas Smeenk, CEO of Hemostemix, expressed gratitude to the authors for their contribution to the scientific community and emphasized the growing evidence supporting the safety and efficacy of ACP-01 in treating various forms of ischemia. With eight peer-reviewed publications covering 318 subjects, the company is confident in ACP-01's potential. Smeenk also hinted at forthcoming news regarding the production and clinical trials of ACP-01, as the company is currently selling the treatment for CLI under exemption.

Founded in 2003, Hemostemix has been recognized by the World Economic Forum as a Technology Pioneer. The company has developed and patented a platform for blood-based stem cell therapeutics, which includes angiogenic cell precursors, neuronal cell precursors, and cardiomyocyte cell precursors. With these promising results, Hemostemix continues to pave the way in advancing stem cell therapies for ischemic conditions.