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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Pontifícia Universidade Católica do Paraná
Sponsor:
Collaborators:
Instituto de Moléstias Cardiovasculares de São José do Rio Preto, Brazil
Hospital Sao Rafael
Hospital Geral Nacional Enrique Cabrera, Cuba
Instituto de Hematología e Inmunología, Cuba
Fundação Araucária, Brazil
Information provided by (Responsible Party):
Danielle Malheiros, Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier:
NCT01903044
First received: July 10, 2013
Last updated: June 26, 2014
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Lower Extremity Ischemia
Leg Ulcer
Peripheral Vascular Disease
Diabetic Foot
Gangrene
Procedure: BM-MNC injection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentric Study of the Autologous Bone Marrow-derived Mononuclear Cells Injection for Treatment of the Patients With Critical Lower Extremity Ischemia

Resource links provided by NLM:


Further study details as provided by Pontifícia Universidade Católica do Paraná:

Primary Outcome Measures:
  • Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical outcome classification [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    Improvement of symptoms, functional capacity, exercises tolerance assessed by change in Rutherford scale of CLI

  • Pain and analgesics use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Quality of life outcome [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
  • Improvement of the coronary and collateral circulation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Survival without amputation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BM-MNC injection
Injection of autologous bone marrow-derived mononuclear cells
Procedure: BM-MNC injection
BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903044

Contacts
Contact: Paulo Brofman, PhD +55 41 3271 2219 paulo.brofman@pucpr.br
Contact: Alexandra Senegaglia, PhD +55 41 3271 2219 alexandra.senegaglia@pucpr.br

Locations
Brazil
Pontifícia Universidade Católica do Paraná Not yet recruiting
Curitiba, Paraná, Brazil, 80215-901
Contact: Carmen Rebelatto, PhD    +55 41 3271 1858    carmen.rebelatto@pucpr.br   
Sponsors and Collaborators
Pontifícia Universidade Católica do Paraná
Instituto de Moléstias Cardiovasculares de São José do Rio Preto, Brazil
Hospital Sao Rafael
Hospital Geral Nacional Enrique Cabrera, Cuba
Instituto de Hematología e Inmunología, Cuba
Fundação Araucária, Brazil
Investigators
Principal Investigator: Paulo Brofman, PhD Pontifícia Universidade Católica do Paraná
  More Information

No publications provided

Responsible Party: Danielle Malheiros, PhD, Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier: NCT01903044     History of Changes
Other Study ID Numbers: ICMI_ 404732/2012-7
Study First Received: July 10, 2013
Last Updated: June 26, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Pontifícia Universidade Católica do Paraná:
Lowe extremity ischemia
Bone marrow
Neoangiogenesis

Additional relevant MeSH terms:
Leg Ulcer
Ischemia
Vascular Diseases
Diabetic Foot
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Diabetic Angiopathies
Foot Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 16, 2014