drugset / Trial / NCT01558908

Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia

NCT01558908 ↗

Phase 1/2 Unknown 15 enrolled Medistem Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a 15 patient clinical trial assessing the safety and feasibility of using Endometrial Regenerative Cells (ERC) in patients with critical limb ischemia (CLI) that are not eligible for surgical or catheter-based interventions. Three doses of ERC will be examined. The hypothesis is that ERC administration will be well-tolerated and possibly induce a therapeutic benefit.

Timeline

Start
2012-05
Primary completion
2013-05
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Endometrial Regenerative Cells Cell therapy 2.5e+07 cells Intramuscular
Subject Endometrial Regenerative Cells Cell therapy 5e+07 cells Intramuscular
Subject Endometrial Regenerative Cells Cell therapy 1e+08 cells Intramuscular

Indications