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

Royan Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ischemic Ulcer

Treatments: Biological: 4times injection; Biological: stem cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01480414

Royan-PVD-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 62 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

4times injection

Experimental group

Description:

the patients with ischemic lower limb ulcer who underwent 4times stem cell injection.

Treatment:

Biological: 4times injection

one injection

Experimental group

Description:

Patients with peripheral artery disease underwent cell transplantation just one time.

Treatment:

Biological: stem cell transplantation