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Trial record 55 of 67 for:    stem cell peripheral arterial disease AND Occlusive

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01903044
Recruitment Status : Unknown
Verified December 2017 by Alexandra Cristina Senegaglia, Pontifícia Universidade Católica do Paraná.
Recruitment status was:  Active, not recruiting
First Posted : July 19, 2013
Last Update Posted : December 13, 2017
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
Information provided by (Responsible Party):
Alexandra Cristina Senegaglia, Pontifícia Universidade Católica do Paraná

Tracking Information
First Submitted Date  ICMJE July 10, 2013
First Posted Date  ICMJE July 19, 2013
Last Update Posted Date December 13, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01903044 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
  • Clinical outcome classification [ Time Frame: 3 months, 6 months ]
    Improvement of symptoms, functional capacity, exercises tolerance assessed by change in Rutherford scale of CLI
  • Pain and analgesics use [ Time Frame: 3 months ]
  • Quality of life outcome [ Time Frame: 3 months, 6 months ]
  • Improvement of the coronary and collateral circulation. [ Time Frame: 3 months ]
  • Survival without amputation [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
Official Title  ICMJE Multicentric Study of the Autologous Bone Marrow-derived Mononuclear Cells Injection for Treatment of the Patients With Critical Lower Extremity Ischemia
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lower Extremity Ischemia
  • Leg Ulcer
  • Peripheral Vascular Disease
  • Diabetic Foot
  • Gangrene
Intervention  ICMJE Procedure: BM-MNC injection
BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles
Study Arms  ICMJE Experimental: BM-MNC injection
Injection of autologous bone marrow-derived mononuclear cells
Intervention: Procedure: BM-MNC injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 16, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01903044
Other Study ID Numbers  ICMJE ICMI_ 404732/2012-7
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexandra Cristina Senegaglia, Pontifícia Universidade Católica do Paraná
Study Sponsor  ICMJE Pontifícia Universidade Católica do Paraná
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Principal Investigator: Paulo Brofman, PhD Pontifícia Universidade Católica do Paraná
PRS Account Pontifícia Universidade Católica do Paraná
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP