LipAge
Phase I Study of a Filler Agent Composed of Mesenchymal Stem Cells Obtained From Autologous Adipose Tissue Associated With Hyaluronic Acid
Sponsor study identifier
Secondary identifiers
OTHER · CEP
interventional
25
1 country
1
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Lipodystrophies are part of a clinically heterogeneous group of disorders characterized by loss (lipoatrophies) and / or accumulation of fat, which usually results in a change of normal tissue surface. Millions of plastic and reconstructive surgeries are performed annually to repair soft tissue defects due to trauma, tumor resection and congenital defects. Surgical options for lipoatrophy, the lipodystrophy type characterized by subcutaneous adipose tissue atrophy, include: Transfer of autologous fat, Dermis - fat graft, Skin flaps and Commercially available fillers. Currently, the most commonly filler agent used for the lipodystrophy treatment is polymethylmethacrylate, considered permanent and with a history of short- and medium-term adverse effects. Biocompatible and temporary filler agents such as hyaluronic acid, polylactic acid and collagen have been used for over 25 years for cosmetic purposes and in lipoatrophies. More recently, the use of autologous fibroblasts proved to be efficient solving acne scars and enabling dermis regeneration. Studies in mice showed that the combination of pre - adipocytes with a biomaterial is much more effective in tissue reconstitution than the injection of adipose tissue only, providing volume and also stimulating cell proliferation and differentiation with increased production of extracellular matrix. This project aims a phase I clinical trial of a filler agent, composed of mesenchymal stem cells derived from autologous adipose tissue associated with hyaluronic acid.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 10, 2014
Actual (reported)January 13, 2014
Actual (reported)March 2015
Date type not reportedThis date has not been verified as actual or estimated.
May 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Adverse Events Analysis
Proportion of patients with non-serious and serious adverse events in the first 12 months after the intervention.
Every visit over the first 12 months after intervention
Efficacy Analysis
1, 3, 6 and 12 months after the intervention
Adipose tissue collection and Transdermal injection of the filler agent, composed of mesenchymal stem cells derived from the autologous adipose tissue, associated with hyaluronic acid.
Transdermal injection of hyaluronic acid only.
Only the patients selected for the Test Group will go through the procedure. The adipose tissue collection will occur in an elective surgery liposuction, in patients who meet the inclusion criteria, after signing the informed consent form. Thus, the material that would be disposed after surgery will be donated to the study. The material for the study will be collected by the tumescent liposuction technique, which involves the removal of subcutaneous fat under local anesthesia.
Hospital Federal de Bonsucesso
Rio de Janeiro, Rio de Janeiro, Brazil
Paulo RC Souza, M.D
Dermatology Service
First Submitted
January 10, 2014
First Posted
January 13, 2014
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2016
Estimated (date passed)Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension
Transdermal injection of the filler agent composed of mesenchymal stem cells derived from autologous adipose tissue associated with hyaluronic acid.
Transdermal injection of hyaluronic acid only.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 4, 2015
Record last verified: 2015-02
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Source: ClinicalTrials.gov.
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