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Updating, Pluristem Therapeutics (PSTI), DSMB Approval for Critical Limb Ischemia (CLI) Trial


PSTI (3/2/10) received approval from an independent Data Safety Monitoring Board (DSMB) to advance its placenta-derived cell therapy product, PLX-PAD.

  • This Phase I study in the EU is to evaluate the safety of PLX-PAD for 3 dosing levels in 15 patients for the treatment of Critical Limb Ischemia (NYSE:CLI), the end-stage of peripheral artery disease (PAD).

Reiterating from our 1/13/10 blog:  PSTI develops a pipeline of products derived from the human placenta, an adult stem cell source.

“Satisfactory results from the previous 2 dose levels and the rapid advancement to the highest dose level is a further indication that PLX-PAD is a safe and potentially efficacious treatment for CLI,” said Professor Doctor Hans-Dieter Volk, chairman of the Institute for Medical Immunology and the Berlin-Brandenburg Center for Regenerative Therapy (BCRT) and the head of the immunology advisory board of the study. “At this dose level, we hope to further establish a safety profile for PLX-PAD while continuing to observe the positive trend towards efficacy with a reduction in the Rutherford Category, a gauge of the severity of CLI.”