Critical Limb Ischemia, Ischemic Ulcers
Conditions
Keywords
rest pain, ischemic ulcers
Brief summary
Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots
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
Interventions
PROCEDUREstem cells transplant
Sponsors
Instituto de Molestias Cardiovasculares
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Suppress pain and heal ischemic ulcers | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| improve quality of life | 6 months |
Countries
Brazil
Contacts
Primary ContactJose D Araújo, MD
Outcome results
None listed