drugset / Trial / NCT01558908
Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |