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NCT00488020 Clinical Trial

Stem Cells for Treating Critical Ischemia

Critical Limb Ischemia Clinical Trial

Official title:
the Use of Autogenous Adult Stem Cells in the Treatment of Critical Ischemia

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00488020
Other study ID # imc1
Secondary ID
Status Unknown status
Phase Phase 1
First received June 15, 2007
Last updated June 12, 2008
Start date April 2006
Est. completion date June 2007

Study information
Verified date June 2007
Source Instituto de Molestias Cardiovasculares
Contact Jose D Araújo, MD
Phone 551732034000
Email imc.terapia.celular@terra.com.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Unknown status
Enrollment 10
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 30 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• stem cells transplant

Locations
Country Name City State
Brazil Instituto de Molestias Cardiovasculares São José do Rio Preto Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
Instituto de Molestias Cardiovasculares

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Suppress pain and heal ischemic ulcers 6 months
Secondary improve quality of life 6 months
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