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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00488020
First Posted: June 19, 2007
Last Update Posted: October 12, 2017
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.
Information provided by:
Instituto de Molestias Cardiovasculares
  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: 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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00488020     History of Changes
Other Study ID Numbers: imc1
First Submitted: June 15, 2007
First Posted: June 19, 2007
Last Update Posted: October 12, 2017
Last Verified: June 2007

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

Additional relevant MeSH terms:
Ischemia
Pathologic Processes