AADSCTPL: Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy

Sponsor

Irmandade Santa Casa de Misericórdia de Porto Alegre (Other)

Overall Status

Unknown status

CT.gov ID

NCT00715546

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lipodystrophy	Procedure: autologous transplantation of liposuction material enriched with adipose-derived stem cells	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2007

Anticipated Primary Completion Date :

Aug 1, 2011

Anticipated Study Completion Date :

Nov 1, 2011

Outcome Measures

Primary Outcome Measures

Clinical evaluation of the transplanted area. [one year]

Secondary Outcome Measures

Presence of neovascularization, adipose transplantation reabsorption, tissue viability [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Irmandade Santa Casa de Misericórdia	Porto Alegre	Rio Grande do Sul	Brazil

Sponsors and Collaborators

Irmandade Santa Casa de Misericórdia de Porto Alegre

Investigators

Principal Investigator: Eduardo M. Chem, MD, Irmandade Santa Casa de Misericórdia de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00715546

Other Study ID Numbers:

ISCMPA 1642/07

First Posted:

Jul 15, 2008

Last Update Posted:

Jun 22, 2011

Last Verified:

Mar 1, 2009

Keywords provided by , ,

Adipose-derived stem cell

Lipodystrophy

Additional relevant MeSH terms:

Lipodystrophy

Study Results

No Results Posted as of Jun 22, 2011