Stem Cells for Treating Critical Ischemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Instituto de Molestias Cardiovasculares.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Instituto de Molestias Cardiovasculares
ClinicalTrials.gov Identifier:
NCT00488020
First received: June 15, 2007
Last updated: June 12, 2008
Last verified: June 2007
  Purpose

Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots


Condition Intervention Phase
Critical Limb Ischemia
Ischemic Ulcers
Procedure: stem cells transplant
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: the Use of Autogenous Adult Stem Cells in the Treatment of Critical Ischemia

Further study details as provided by Instituto de Molestias Cardiovasculares:

Primary Outcome Measures:
  • Suppress pain and heal ischemic ulcers [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • improve quality of life [ Time Frame: 6 months ]

Estimated Enrollment: 10
Study Start Date: April 2006
Estimated Study Completion Date: June 2007
Detailed Description:

About 500cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution in albumin (40cc)the mononuclear cells are injected into the calf muscles through 40 shots.This procedure is indicated for patients with lower limb ischemia on whom all the others known therapies have failed

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fontaine's classification grade 3 and 4 patients

Exclusion Criteria:

  • Record of cancer in the last 5 years
  • Over 80 years
  • Diabetic retinopathy
  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: NCT00488020

Contacts
Contact: Jose D Araújo, MD 551732034000 imc.terapia.celular@terra.com.br

Locations
Brazil
Instituto de Molestias Cardiovasculares Recruiting
São José do Rio Preto, Sao Paulo, Brazil, 15015-210
Contact: Jose D Araujo, MD    551732034000 ext 112    imc.terapia.celular@terra.com br   
Sponsors and Collaborators
Instituto de Molestias Cardiovasculares
Investigators
Principal Investigator: Jose D Araújo, MD Instituto de Molestias Cardiovasculares
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00488020     History of Changes
Other Study ID Numbers: imc1
Study First Received: June 15, 2007
Last Updated: June 12, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto de Molestias Cardiovasculares:
rest pain
ischemic ulcers

Additional relevant MeSH terms:
Ischemia
Ulcer
Pathologic Processes

ClinicalTrials.gov processed this record on September 11, 2014