NCT00715546

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

June 22, 2011

Status Verified

March 1, 2009

Enrollment Period

3.8 years

First QC Date

July 11, 2008

Last Update Submit

June 21, 2011

Conditions

Lipodystrophy

Keywords

Adipose-derived stem cellLipodystrophy

Outcome Measures

Primary Outcomes (1)

  • Clinical evaluation of the transplanted area.

    one year

Secondary Outcomes (1)

  • Presence of neovascularization, adipose transplantation reabsorption, tissue viability

    one year

Interventions

autologous transplantation of liposuction material enriched with adipose-derived stem cellsPROCEDURE

Lipoinjection enriched with adipose-derived stem-cells.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lipodystrophies with necessity of fat grafting
  • accept to participate of the study

You may not qualify if:

  • HIV infection
  • Metastatic malignancy
  • Body mass index \< 20 kg/m²
  • Other severe systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irmandade Santa Casa de Misericórdia

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Lipodystrophy

Condition Hierarchy (Ancestors)

Skin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Eduardo M. Chem, MD

    Irmandade Santa Casa de Misericórdia de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2008

First Posted

July 15, 2008

Study Start

October 1, 2007

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

June 22, 2011

Record last verified: 2009-03

Locations

BR(1)