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Stem Cells for Treating Critical Ischemia

NCT ID: NCT00488020

Last Updated: 2008-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-06-30

Brief Summary

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

Detailed Description

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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

Conditions

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Critical Limb Ischemia Ischemic Ulcers

Keywords

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rest pain ischemic ulcers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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stem cells transplant

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Molestias Cardiovasculares

OTHER

Sponsor Role lead

Principal Investigators

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Jose D Araújo, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Molestias Cardiovasculares

Locations

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Instituto de Molestias Cardiovasculares

São José do Rio Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Jose D Araújo, MD

Role: CONTACT

Phone: 551732034000

Email: [email protected]

Facility Contacts

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Jose D Araujo, MD

Role: primary

Other Identifiers

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imc1

Identifier Type: -

Identifier Source: org_study_id