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NCT00715546 Clinical Trial

Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy

Lipodystrophy Clinical Trial

— AADSCTPL  

Official title:
Phase 1 Study of Autologous-Derived Stem Cell Transplantation in Patients With Lipodystrophy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00715546
Other study ID # ISCMPA 1642/07
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received July 11, 2008
Last updated June 21, 2011
Start date October 2007
Est. completion date November 2011

Study information
Verified date March 2009
Source Irmandade Santa Casa de Misericórdia de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 5
Est. completion date November 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• autologous transplantation of liposuction material enriched with adipose-derived stem cells
Lipoinjection enriched with adipose-derived stem-cells.

Locations
Country Name City State
Brazil Irmandade Santa Casa de Misericórdia Porto Alegre Rio Grande do Sul

Sponsors (1)
Lead Sponsor Collaborator
Irmandade Santa Casa de Misericórdia de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical evaluation of the transplanted area. one year Yes
Secondary Presence of neovascularization, adipose transplantation reabsorption, tissue viability one year Yes
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