Stem Cells for Treating Critical Ischemia

Instituto de Molestias Cardiovasculares

Status and phase: Unknown; Phase 1

Conditions: Critical Limb Ischemia; Ischemic Ulcers

Treatments: Procedure: stem cells transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT00488020

imc1

Details and patient eligibility

About

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

Full 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

Enrollment: 10 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)