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

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ClinicalTrials.gov Identifier: NCT00715546
Recruitment Status : Unknown
Verified March 2009 by Irmandade Santa Casa de Misericórdia de Porto Alegre.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2008
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:
Irmandade Santa Casa de Misericórdia de Porto Alegre

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
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 : October 2007
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : November 2011

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


Primary Outcome Measures :
  1. Clinical evaluation of the transplanted area. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Presence of neovascularization, adipose transplantation reabsorption, tissue viability [ Time Frame: one year ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715546


Locations
Brazil
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

Responsible Party: Eduardo Mainieri Chem, Phd, Irmandade Santa Casa de Misericórdia de Porto Alegre
ClinicalTrials.gov Identifier: NCT00715546     History of Changes
Other Study ID Numbers: ISCMPA 1642/07
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: March 2009

Keywords provided by Irmandade Santa Casa de Misericórdia de Porto Alegre:
Adipose-derived stem cell
Lipodystrophy

Additional relevant MeSH terms:
Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases