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Side Effects of 4 Times Bone Marrow Mono Nuclear Transplantation in Patients With Ischemic Lower Limb

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01480414
First Posted: November 28, 2011
Last Update Posted: December 27, 2012
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.
Information provided by (Responsible Party):
Royan Institute
November 23, 2011
November 28, 2011
December 27, 2012
September 2010
April 2012   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01480414 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Side Effects of 4 Times Bone Marrow Mono Nuclear Transplantation in Patients With Ischemic Lower Limb
Evaluation the Side Effects of Repeated Bone Marrow Derived Mono Nuclear Stem Cells Transplantation in Patients With Lower Limb Ischemic Ulcer
Critical limb ischemia (CLI) results from severe occlusive disease that impairs distal limb perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic needs of the tissue, even under resting conditions. The limits of peripheral artery disease (PAD) compensatory mechanisms, such as distal vasodilatation and collateral formation, have been exceeded at this point. PAD is a widespread disease, affecting up to 15% of all adults older than 55 years. Formation of true new blood vessels, or angiogenesis, and development of collateral vessels from preexisting blood vessels, or arteriogenesis, is important in the pathophysiology of vascular disease. By stimulating these processes the investigators might be able to provide an alternative treatment strategy for patients with lower limb ischemia. In response to tissue injury and remodeling, neovascularization usually occurs via the proliferation and migration of progenitor endothelial cells (EPC) from preexisting vasculature. Indeed, recent studies have shown that bone-marrow mononuclear cell (BM-MNC) implantation increases collateral vessel formation in patients with limb ischemia. So the investigators determine to evaluate the efficacy of repeated MNC transplantation in patients with ischemic lower limb.
In this study we transparent bone marrow derived mononuclear stem cells 4 times to the ischemic limb of 11 patients with PAD.first of all all the patients evaluate by physical examination,PFWD,ABI and serologic tests.then underwent bone marrow aspiration to take sample.In our lab the MNC are separated and divided in to equal doses.one of them inject to the ischemic foot and the othr one are freezed and inject after 3weeks.3 weeks after second injection again patient underwent bone marrow aspiration and the same process repeat.then after 4times transplantation,patients are followed up after 1,3,6,9,12 months after injection and evaluate by physical examination,PFWD,ABI and serologic tests.all the data are collected and analysed and the result will be shown.3 patients underwent cell transplantation just one time due to one time bone marrow aspiration.They are followed up after 1,3,6,9,12 months after injection and evaluate by physical examination,PFWD,ABI and serologic tests.at the end of the study patients with 4imes injection and 1time injection will be compared.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ischemic Ulcer
  • Biological: 4times injection
    bone marrow derived mono nuclear stem cell
  • Biological: stem cell transplantation
    Mono nuclear stem cell transplantation by intra muscular injection to the ischemic lower limb
  • Experimental: 4times injection
    the patients with ischemic lower limb ulcer who underwent 4times stem cell injection.
    Intervention: Biological: 4times injection
  • Experimental: one injection
    Patients with peripheral artery disease underwent cell transplantation just one time.
    Intervention: Biological: stem cell transplantation
Molavi B, Zafarghandi MR, Aminizadeh E, Hosseini SE, Mirzayi H, Arab L, Baharvand H, Aghdami N. Safety and Efficacy of Repeated Bone Marrow Mononuclear Cell Therapy in Patients with Critical Limb Ischemia in a Pilot Randomized Controlled Trial. Arch Iran Med. 2016 Jun;19(6):388-96. doi: 0161906/AIM.004.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2012
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ischemic lower limb based on TASK guide line
  • Rutherford score:2,3
  • ABI<0.6
  • Absolute ankle pressure < 60 mmHg
  • Both gender
  • Age:20-62years

Exclusion Criteria:

  • EF<30%
  • Cr>2
  • HbA1c>8%
  • Bone marrow disorders:leukemia
  • Cognitive disorders
  • Infections
  • MI with ST elevation during last month
  • Malignancy
  • Immunologic or rheumatologic disorders
Sexes Eligible for Study: All
20 Years to 62 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT01480414
Royan-PVD-002
Yes
Not Provided
Not Provided
Royan Institute
Royan Institute
Not Provided
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
Royan Institute
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP