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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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01480414
Enrollment
20
Registered
2011-11-28
Start date
2010-09-30
Completion date
2012-05-31
Last updated
2012-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Ulcer

Keywords

bone marrow mono nuclear stem cell ischemic ulcer

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICAL4times injection

bone marrow derived mono nuclear stem cell

BIOLOGICALstem cell transplantation

Mono nuclear stem cell transplantation by intra muscular injection to the ischemic lower limb

Sponsors

Royan Institute
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 62 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
side effects3monthsevaluation the side effect of cell injection like:allergic reaction,fever,skin eruption,pain increasing,decrease in walking distance,ulcer severity

Secondary

MeasureTime frameDescription
PFWD3monthsEvaluation the pain free walking distance after cell transplantation.
ABI3monthsevaluation the improvement the score of ABI after stem cell transplantation .
size and depth of ulcer3monthsevaluation the improvement of ulcer by measuring the size and depth of ulcer in millimeter after transplantation.
Amputation6monthsEvaluation the need of limb amputation because of worsening the ulcer after cell injection.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026