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

Diabetic Foot Clinical Trial

Official title:

Multicentric Study of the Autologous Bone Marrow-derived Mononuclear Cells Injection for Treatment of the Patients With Critical Lower Extremity Ischemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01903044
• Other study ID #: ICMI_ 404732/2012-7
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: July 10, 2013
• Last updated: December 11, 2017
• Start date: September 2014
• Est. completion date: September 2018

Study information

• Verified date: December 2017
• Source: Pontifícia Universidade Católica do Paraná
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Gangrene
• Ischemia
• Leg Ulcer
• Lower Extremity Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Brazil	Pontifícia Universidade Católica do Paraná	Curitiba	Paraná

Sponsors (6)

Lead Sponsor	Collaborator
Pontifícia Universidade Católica do Paraná	Fundação Araucária, Hospital Geral Nacional Enrique Cabrera, Cuba, Hospital Sao Rafael, Instituto de Hematología e Inmunología, Cuba, Instituto de Moléstias Cardiovasculares de São José do Rio Preto, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions		3 months
Secondary	Clinical outcome classification	Improvement of symptoms, functional capacity, exercises tolerance assessed by change in Rutherford scale of CLI	3 months, 6 months
Secondary	Pain and analgesics use		3 months
Secondary	Quality of life outcome		3 months, 6 months
Secondary	Improvement of the coronary and collateral circulation.		3 months
Secondary	Survival without amputation		6 months