A Phase 1/2 interventional study of 4times injection and stem cell transplantation in Ischemic Ulcer, sponsored by Royan Institute. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 20 Years to 62 Years. Per ClinicalTrials.gov, last updated 2012-12-27.
Sponsored by Royan Institute · Phase 1/2, Interventional, and Treatment
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.
2,058 studies on the registry are indexed under Ischemia; 347 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 1,359 interventional studies indexed under Ischemia.
Browse Ischemia studies →Royan Institute is the lead sponsor of 92 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
the patients with ischemic lower limb ulcer who underwent 4times stem cell injection.
Biological: 4times injection
Patients with peripheral artery disease underwent cell transplantation just one time.
Biological: stem cell transplantation
bone marrow derived mono nuclear stem cell
Mono nuclear stem cell transplantation by intra muscular injection to the ischemic lower limb
side effects
evaluation the side effect of cell injection like:allergic reaction,fever,skin eruption,pain increasing,decrease in walking distance,ulcer severity
Time frame: 3months
PFWD
Evaluation the pain free walking distance after cell transplantation.
Time frame: 3months
ABI
evaluation the improvement the score of ABI after stem cell transplantation .
Time frame: 3months
size and depth of ulcer
evaluation the improvement of ulcer by measuring the size and depth of ulcer in millimeter after transplantation.
Time frame: 3months
Amputation
Evaluation the need of limb amputation because of worsening the ulcer after cell injection.
Time frame: 6months
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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