Lipodystrophy Clinical Trial
— AADSCTPLOfficial title:
Phase 1 Study of Autologous-Derived Stem Cell Transplantation in Patients With Lipodystrophy
The aim of this study is to determine the safety of the autologous transplantation of adipose-derived stem cells in the treatment of lipodystrophies.
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Irmandade Santa Casa de Misericórdia | Porto Alegre | Rio Grande do Sul |
Lead Sponsor | Collaborator |
---|---|
Irmandade Santa Casa de Misericórdia de Porto Alegre |
Brazil,
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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