Back to resultsAutologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy (AADSCTPL)
Primary Purpose
Lipodystrophy
Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
autologous transplantation of liposuction material enriched with adipose-derived stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Lipodystrophy focused on measuring Adipose-derived stem cell, Lipodystrophy
Eligibility Criteria
Inclusion Criteria:
- lipodystrophies with necessity of fat grafting
- accept to participate of the study
Exclusion Criteria:
- HIV infection
- Metastatic malignancy
- Body mass index < 20 kg/m²
- Other severe systemic disease
Sites / Locations
- Irmandade Santa Casa de Misericórdia
Outcomes
Primary Outcome Measures
Clinical evaluation of the transplanted area.
Secondary Outcome Measures
Presence of neovascularization, adipose transplantation reabsorption, tissue viability
Full Information
NCT ID
NCT00715546
First Posted
July 11, 2008
Last Updated
June 21, 2011
Sponsor
Irmandade Santa Casa de Misericórdia de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT00715546
Brief Title
Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy
Acronym
AADSCTPL
Official Title
Phase 1 Study of Autologous-Derived Stem Cell Transplantation in Patients With Lipodystrophy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Irmandade Santa Casa de Misericórdia de Porto Alegre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to determine the safety of the autologous transplantation of adipose-derived stem cells in the treatment of lipodystrophies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipodystrophy
Keywords
Adipose-derived stem cell, Lipodystrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
autologous transplantation of liposuction material enriched with adipose-derived stem cells
Intervention Description
Lipoinjection enriched with adipose-derived stem-cells.
Primary Outcome Measure Information:
Title
Clinical evaluation of the transplanted area.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Presence of neovascularization, adipose transplantation reabsorption, tissue viability
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lipodystrophies with necessity of fat grafting
accept to participate of the study
Exclusion Criteria:
HIV infection
Metastatic malignancy
Body mass index < 20 kg/m²
Other severe systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo M. Chem, MD
Organizational Affiliation
Irmandade Santa Casa de Misericórdia de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irmandade Santa Casa de Misericórdia
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy
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