Stem Cells for Treating Critical Ischemia

This study is currently recruiting participants.

Verified by Instituto de Molestias Cardiovasculares, June 2007

Sponsored by:	Instituto de Molestias Cardiovasculares
Information provided by:	Instituto de Molestias Cardiovasculares
ClinicalTrials.gov Identifier:	NCT00488020

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 I

U.S. FDA Resources

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

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

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, 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

Sponsors and Collaborators

Instituto de Molestias Cardiovasculares

Investigators

Principal Investigator:

Jose D Araújo, MD

Instituto de Molestias Cardiovasculares

More Information

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

Keywords provided by Instituto de Molestias Cardiovasculares:

rest pain
ischemic ulcers

Study placed in the following topic categories:

Ulcer
Pain
Ischemia

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009