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Stem Cells for Treating Critical Ischemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by Instituto de Molestias Cardiovasculares.
Recruitment status was:  Recruiting
Information provided by:
Instituto de Molestias Cardiovasculares Identifier:
First received: June 15, 2007
Last updated: June 12, 2008
Last verified: June 2007
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: Intervention Model: Single Group Assignment
Masking: None (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

Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00488020

Contact: Jose D Araújo, MD 551732034000

Instituto de Molestias Cardiovasculares Recruiting
São José do Rio Preto, Sao Paulo, Brazil, 15015-210
Contact: Jose D Araujo, MD    551732034000 ext 112 br   
Sponsors and Collaborators
Instituto de Molestias Cardiovasculares
Principal Investigator: Jose D Araújo, MD Instituto de Molestias Cardiovasculares
  More Information Identifier: NCT00488020     History of Changes
Other Study ID Numbers: imc1
Study First Received: June 15, 2007
Last Updated: June 12, 2008

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

Additional relevant MeSH terms:
Pathologic Processes processed this record on September 20, 2017