Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia
|ClinicalTrials.gov Identifier: NCT01558908|
Recruitment Status : Unknown
Verified March 2012 by Medistem Inc..
Recruitment status was: Not yet recruiting
First Posted : March 20, 2012
Last Update Posted : March 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Diseases||Biological: Administration of ERC||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic,Unrelated, Menstrual Derived, Mesenchymal Stem Cell-Like, Endometrial Cells; Administered Intramuscular|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||July 2013|
|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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|