Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia
Recruitment status was: Not yet recruiting
|Peripheral Vascular Diseases||Biological: Administration of ERC||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Allogeneic,Unrelated, Menstrual Derived, Mesenchymal Stem Cell-Like, Endometrial Cells; Administered Intramuscular|
- Safety [ Time Frame: 52 weeks ]Adverse and serious events recorded
- Efficacy [ Time Frame: 12 weeks ]Improvements post-treatment in rest pain (VAS), toe pressure and ABI, transcutaneous oximetry and ulcer status (with picture).
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|Experimental: Intramuscular injection of ERC||
Biological: Administration of ERC
Patients will be treated with either 25 million, 50 million, or 100 million ERC by intramuscular injection.
The purpose of the trial is to determine safety of intramuscularly derived menstrual mesenchymal stem cells (otherwise known as Endometrial Regenerative Cells, or ERC) in patients with critical limb ischemia ineligible for revascularization. Safety will be defined as freedom from treatment associated adverse events. Efficacy parameters will comprise endpoints of changes in ankle-brachial index, toe-brachial index, TcPO2, ulcer healing, rest pain, quality of life, and reduction in amputation.
Patients will receive 25, 50, or 100 million menstrual derived mesenchymal stem cells (Endometrial Regenerative Cells: ERC) in ten injections of 2.5, 5, or 10 million mesenchymal stem cells suspended in a volume of 1 ml per injection. Injections will be spaced at least 2 centimeters apart from each other in the gastrocnemius muscle above the failed vascular perfusion area.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558908
|Contact: Michael P Murphy, MDfirstname.lastname@example.org|
|Contact: Janet Klein, RN||(317) email@example.com|
|United States, Indiana|
|Indiana University School of Medicine||Not yet recruiting|
|Indianapolis, Indiana, United States|
|Contact: Michael P Murphy, MD 317-630-8288 firstname.lastname@example.org|
|Principal Investigator: Michael P Murphy, MD|
|Principal Investigator:||Michael P Murphy, MD||Indiana University|