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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Irmandade Santa Casa de Misericórdia de Porto Alegre.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Irmandade Santa Casa de Misericórdia de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00715546
First received: July 11, 2008
Last updated: June 21, 2011
Last verified: March 2009
  Purpose

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 Intervention Phase
Lipodystrophy
Procedure: autologous transplantation of liposuction material enriched with adipose-derived stem cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Autologous-Derived Stem Cell Transplantation in Patients With Lipodystrophy

Resource links provided by NLM:


Further study details as provided by Irmandade Santa Casa de Misericórdia de Porto Alegre:

Primary Outcome Measures:
  • Clinical evaluation of the transplanted area. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Presence of neovascularization, adipose transplantation reabsorption, tissue viability [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: October 2007
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: autologous transplantation of liposuction material enriched with adipose-derived stem cells
    Lipoinjection enriched with adipose-derived stem-cells.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 11, 2008
Last Updated: June 21, 2011
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on September 22, 2014