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Sponsored by: |
Instituto de Molestias Cardiovasculares |
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Information provided by: | Instituto de Molestias Cardiovasculares |
ClinicalTrials.gov Identifier: | NCT00488020 |
Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots
Condition | Intervention | Phase |
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Critical Limb Ischemia Ischemic Ulcers |
Procedure: stem cells transplant |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | the Use of Autogenous Adult Stem Cells in the Treatment of Critical Ischemia |
Estimated Enrollment: | 10 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | June 2007 |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jose D Araújo, MD | 551732034000 | imc.terapia.celular@terra.com.br |
Brazil, Sao Paulo | |
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 |
Principal Investigator: | Jose D Araújo, MD | Instituto de Molestias Cardiovasculares |
Study ID Numbers: | imc1 |
Study First Received: | June 15, 2007 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00488020 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
rest pain ischemic ulcers |
Ulcer Pain Ischemia |
Pathologic Processes Ischemia |