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NCT Number: NCT01480414

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

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.

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Key information

Conditions

Ischemic Ulcer

Age range

20 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4times injection

Biological

bone marrow derived mono nuclear stem cell

Stem Cell Transplantation

Biological

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

Primary outcomes

  1. 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

Secondary outcomes

  1. PFWD

    Time frame: 3months

    Evaluation the pain free walking distance after cell transplantation.

  2. ABI

    Time frame: 3months

    evaluation the improvement the score of ABI after stem cell transplantation .

  3. 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.

  4. Amputation

    Time frame: 6months

    Evaluation the need of limb amputation because of worsening the ulcer after cell injection.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

Evaluation the Side Effects of Repeated Bone Marrow Derived Mono Nuclear Stem Cells Transplantation in Patients With Lower Limb Ischemic Ulcer

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 28, 2011
Registry last updated
Dec 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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