Abstract

A phase II clinical trial in patients with Buerger’s disease using bone marrow derived, pooled, allogeneic mesenchymal stromal cells

Anoop CH, Assistant Director – Clinical Research, Stempeutics Research Pvt. Ltd.

We have developed a cell based therapeutic product stempeucel®, which comprises of Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells. A multicentric phase II dose finding study was conducted in no-option Buerger’s disease patients. A total of 90 patients were included in the study: 36 in each of 1 and 2 million cells/kg dose groups, and 18 in control group. Both the primary endpoints were met at 6 months follow-up, which were, rate of reduction of rest pain (0.3 (SE=0.13) units per month (p = 0.0193)) and rate of reduction in ulcer area (11% (SE=0.05) per month (p=0.0253)) in 2M/kg group as compare to control group. Similarly, 2M/kg group had 0.03 (SE=0.01) unit increase in the ABPI per month compared to control group (p=0.0132) suggesting improved blood flow to the lower limbs. Statistically significant improvements were observed in total walking distance and quality of life in the stempeucel® treatment groups compared to control group. Stempeucel® was well tolerated and all adverse events were manifestations of disease process and not related to stempeucel®. Hence it is reasonable to conclude that stempeucel® can be a potential therapy for no-option patients of Critical Limb Ischemia due to Buerger’s disease.