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

NCT ID: NCT01480414

Last Updated: 2012-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Ischemic Ulcer

Keywords

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bone marrow mono nuclear stem cell ischemic ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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4times injection

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

Group Type EXPERIMENTAL

4times injection

Intervention Type BIOLOGICAL

bone marrow derived mono nuclear stem cell

one injection

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

Group Type EXPERIMENTAL

stem cell transplantation

Intervention Type BIOLOGICAL

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

Interventions

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4times injection

bone marrow derived mono nuclear stem cell

Intervention Type BIOLOGICAL

stem cell transplantation

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

mohammad zafarghandi, MD

Role: STUDY_DIRECTOR

surgery scientist

Nasser Aghdami, MD,PhD

Role: STUDY_DIRECTOR

head of Royan cell therapy center

Behnam Molavi, MD

Role: PRINCIPAL_INVESTIGATOR

Surgery scientist

Locations

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Royan Institute

Tehran, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 27293053 (View on PubMed)

Other Identifiers

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Royan-PVD-002

Identifier Type: -

Identifier Source: org_study_id