Side Effects of 4 Times Bone Marrow Mono Nuclear Transplantation in Patients With Ischemic Lower Limb
|ClinicalTrials.gov Identifier: NCT01480414|
Recruitment Status : Completed
First Posted : November 28, 2011
Last Update Posted : December 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Ulcer||Biological: 4times injection Biological: stem cell transplantation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation the Side Effects of Repeated Bone Marrow Derived Mono Nuclear Stem Cells Transplantation in Patients With Lower Limb Ischemic Ulcer|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||May 2012|
Experimental: 4times injection
the patients with ischemic lower limb ulcer who underwent 4times stem cell injection.
Biological: 4times injection
bone marrow derived mono nuclear stem cell
Experimental: one injection
Patients with peripheral artery disease underwent cell transplantation just one time.
Biological: stem cell transplantation
Mono nuclear stem cell transplantation by intra muscular injection to the ischemic lower limb
- side effects [ Time Frame: 3months ]evaluation the side effect of cell injection like:allergic reaction,fever,skin eruption,pain increasing,decrease in walking distance,ulcer severity
- PFWD [ Time Frame: 3months ]Evaluation the pain free walking distance after cell transplantation.
- ABI [ Time Frame: 3months ]evaluation the improvement the score of ABI after stem cell transplantation .
- size and depth of ulcer [ Time Frame: 3months ]evaluation the improvement of ulcer by measuring the size and depth of ulcer in millimeter after transplantation.
- Amputation [ Time Frame: 6months ]Evaluation the need of limb amputation because of worsening the ulcer after cell injection.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480414
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||Hamid Gourabi, PhD||Head of Royan Institute|
|Study Director:||mohammad zafarghandi, MD||surgery scientist|
|Study Director:||Nasser Aghdami, MD,PhD||head of Royan cell therapy center|
|Principal Investigator:||Behnam Molavi, MD||Surgery scientist|