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

Phase 1

• Conditions: Diabetic Foot; Lower Extremity Ischemia; Leg Ulcer; Peripheral Vascular Disease; Gangrene
• Interventions: Procedure: BM-MNC injection

• Registration Number: NCT01903044
• Lead Sponsor: Pontifícia Universidade Católica do Paraná

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-19
• Study Start: 2014-09
• Primary Completion: 2017-03
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BM-MNC injection	BM-MNC injection	Injection of autologous bone marrow-derived mononuclear cells

Primary Outcome Measures

Name	Time	Method
Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions	3 months

Secondary Outcome Measures

Name	Time	Method
Quality of life outcome	3 months, 6 months
Clinical outcome classification	3 months, 6 months	Improvement of symptoms, functional capacity, exercises tolerance assessed by change in Rutherford scale of CLI
Pain and analgesics use	3 months
Improvement of the coronary and collateral circulation.	3 months
Survival without amputation	6 months

Trial Locations

Locations (1)

Pontifícia Universidade Católica do Paraná; 🇧🇷 Curitiba, Paraná, Brazil