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

June 21, 2011 updated by: Irmandade Santa Casa de Misericórdia de Porto Alegre

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Irmandade Santa Casa de Misericórdia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical evaluation of the transplanted area.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Presence of neovascularization, adipose transplantation reabsorption, tissue viability
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Irmandade Santa Casa de Misericórdia de Porto Alegre

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ANTICIPATED)

August 1, 2011

Study Completion (ANTICIPATED)

November 1, 2011

Study Registration Dates

First Submitted

July 11, 2008

First Submitted That Met QC Criteria

July 12, 2008

First Posted (ESTIMATE)

July 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISCMPA 1642/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lipodystrophy

Clinical Trials on autologous transplantation of liposuction material enriched with adipose-derived stem cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe