Stem Cells for Treating Critical Ischemia

Instituto de Molestias Cardiovasculares10 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critical Limb Ischemia Ischemic Ulcers

Interventions

stem cells transplantPROCEDURE

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto de Molestias Cardiovasculares

São José do Rio Preto, São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

Suppress pain and heal ischemic ulcers

Time frame: 6 months

Secondary Outcomes

improve quality of life

Time frame: 6 months

Central Contacts

Jose D Araújo, MD

CONTACT

551732034000 imc.terapia.celular@terra.com.br

Data from ClinicalTrials.gov

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