Autologous Adipose-Derived Stem Cell Transplantation in P... | NCT00715546

Studies
Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy

NCT00715546

Sponsor

Irmandade Santa Casa de Misericórdia de Porto Alegre

Status

Unknown status

Last Update Posted

Jun 22, 2011Estimated

Enrollment

5Actual

Phase

Phase 1

Conditions

Lipodystrophy

Interventions

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

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Aug 2011Estimated

Completion Date

Nov 2011Estimated

First Submitted Date

Jul 11, 2008

First Submission Date that Met QC Criteria

Jul 12, 2008

First Posted Date

Jul 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2011

Last Update Posted Date

Jun 22, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Irmandade Santa Casa de Misericórdia de Porto AlegreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
autologous transplantation of liposuction material enriched with adipose-derived stem cells	Procedure	Lipoinjection enriched with adipose-derived stem-cells.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eduardo M. Chem, MD	Irmandade Santa Casa de Misericórdia de Porto Alegre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Irmandade Santa Casa de Misericórdia		Porto Alegre	Rio Grande do Sul		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D008060	Lipodystrophy

Ancestor Terms

ID	Term
D012875	Skin Diseases, Metabolic
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D052439	Lipid Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided