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Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating

NCT ID: NCT01903044

Last Updated: 2017-12-13

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

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-09-30

Brief Summary

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The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.

Detailed Description

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Critical limb ischemia (CLI) is a debilitating and disabling disease. Symptoms include pain at rest, loss of tissue integrity, distal amputations and have a major impact on the quality of life. Despite recent advances in surgical vascular procedures, a large number of patients (approximately 40%) are not eligible for these revascularization procedures. New strategies for revascularization need to be explored. Besides, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. Recent evidence indicates that bone marrow-derived mononuclear cells (BM-MNC) are a potential new therapeutic target.

Conditions

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Lower Extremity Ischemia Leg Ulcer Peripheral Vascular Disease Diabetic Foot Gangrene

Keywords

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Lowe extremity ischemia Bone marrow Neoangiogenesis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BM-MNC injection

Injection of autologous bone marrow-derived mononuclear cells

Group Type EXPERIMENTAL

BM-MNC injection

Intervention Type PROCEDURE

BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles

Interventions

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BM-MNC injection

BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Critical lower limb ischemia, defined as ischemic pain at rest and / or the presence of minor tissue loss, with the possibility of healing.
* Failure of conventional medical treatment and attempts to open or percutaneous revascularization before, with an observation period of two months after the last attempt at revascularization.
* Patients considered at high risk for new revascularization procedure by at least two independent observers.

Exclusion Criteria

* Expected life span less than six months
* Large tissue loss in the ischemic limb indicating the need for limb amputation in the short term.
* Evidence of osteomyelitis in the ischemic extremity.
* Current or previous history of neoplasia.
* Unstable angina, recent stroke or other medical condition that contraindicate anesthesia for bone marrow aspiration.
* Proliferative retinopathy.
* Debilitating disease with a life span less than one year.
* Myelofibrosis, myelodysplasia or other diseases that affect the bone marrow.
* Use of alcohol in excess of twice-daily doses or history of illicit drug use.
* Need for continuous high doses of drug therapy with steroids (more than 7.5 mg/day).
* Positivity for HIV or syphilis
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Moléstias Cardiovasculares de São José do Rio Preto, Brazil

UNKNOWN

Sponsor Role collaborator

Hospital Sao Rafael

OTHER

Sponsor Role collaborator

Hospital Geral Nacional Enrique Cabrera, Cuba

UNKNOWN

Sponsor Role collaborator

Instituto de Hematología e Inmunología, Cuba

UNKNOWN

Sponsor Role collaborator

Fundação Araucária

OTHER

Sponsor Role collaborator

Pontifícia Universidade Católica do Paraná

OTHER

Sponsor Role lead

Responsible Party

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Alexandra Cristina Senegaglia

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paulo Brofman, PhD

Role: PRINCIPAL_INVESTIGATOR

Pontifícia Universidade Católica do Paraná

Locations

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Pontifícia Universidade Católica do Paraná

Curitiba, Paraná, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ICMI_ 404732/2012-7

Identifier Type: -

Identifier Source: org_study_id