Back to resultsStem Cells for Treating Critical Ischemia
Primary Purpose
Critical Limb Ischemia, Ischemic Ulcers
Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
stem cells transplant
Sponsored by
About this trial
This is an interventional treatment trial for Critical Limb Ischemia focused on measuring rest pain, ischemic ulcers
Eligibility 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
Sites / Locations
- Instituto de Molestias CardiovascularesRecruiting
Outcomes
Primary Outcome Measures
Suppress pain and heal ischemic ulcers
Secondary Outcome Measures
improve quality of life
Full Information
NCT ID
NCT00488020
First Posted
June 15, 2007
Last Updated
June 12, 2008
Sponsor
Instituto de Molestias Cardiovasculares
1. Study Identification
Unique Protocol Identification Number
NCT00488020
Brief Title
Stem Cells for Treating Critical Ischemia
Official Title
the Use of Autogenous Adult Stem Cells in the Treatment of Critical Ischemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Instituto de Molestias Cardiovasculares
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia, Ischemic Ulcers
Keywords
rest pain, ischemic ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
stem cells transplant
Primary Outcome Measure Information:
Title
Suppress pain and heal ischemic ulcers
Time Frame
6 months
Secondary Outcome Measure Information:
Title
improve quality of life
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose D Araújo, MD
Phone
551732034000
Email
imc.terapia.celular@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose D Araújo, MD
Organizational Affiliation
Instituto de Molestias Cardiovasculares
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Molestias Cardiovasculares
City
São José do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15015-210
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose D Araujo, MD
Phone
551732034000
Ext
112
Email
imc.terapia.celular@terra.com br
12. IPD Sharing Statement
Learn more about this trial
Stem Cells for Treating Critical Ischemia
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