Side Effects of 4 Times Bone Marrow Mono Nuclear Transplantation in Patients With Ischemic Lower Limb
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|