Safety Study of Filler Agent Composed of Autologous Mesenchymal Stem Cells and Hyaluronic Acid
LipAge
Phase I Study of a Filler Agent Composed of Mesenchymal Stem Cells Obtained From Autologous Adipose Tissue Associated With Hyaluronic Acid
2 other identifiers
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2015
1 active site
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
First Submitted
Initial submission to the registry
January 10, 2014
CompletedFirst Posted
Study publicly available on registry
January 13, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFebruary 4, 2015
February 1, 2015
1.2 years
January 10, 2014
February 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Efficacy Analysis
1, 3, 6 and 12 months after the intervention
Study Arms (2)
Test
EXPERIMENTALAdipose tissue collection and Transdermal injection of the filler agent, composed of mesenchymal stem cells derived from the autologous adipose tissue, associated with hyaluronic acid.
Control
ACTIVE COMPARATORTransdermal injection of hyaluronic acid only.
Interventions
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.
Transdermal injection of the filler agent composed of mesenchymal stem cells derived from autologous adipose tissue associated with hyaluronic acid.
Eligibility Criteria
You may qualify if:
- Male or female over 18 years;
- Signature of the ICF;
- Suitable for the following preoperative laboratory tests results: complete blood count, coagulation, biochemistry, electrocardiogram, hepatogram and β-human chorionic gonadotropin (hCG) for women of childbearing age.
You may not qualify if:
- Patients unable to undergo surgery liposuction with Klein technique as those with severe cardiovascular disease, severe coagulation disorders including thrombophilia and pregnancy;
- Patients with limited understanding of the procedure;
- Pregnant or lactating;
- Under 18 years;
- Immunosuppressed;
- Lack of signature of the ICF;
- Use of drugs;
- Patients with preoperative results considered inadequate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cryopraxis Criobiologia Ltda.lead
- Hospital Federal de Bonsucessocollaborator
Study Sites (1)
Hospital Federal de Bonsucesso
Rio de Janeiro, Rio de Janeiro, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paulo RC Souza, M.D
Dermatology Service
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2014
First Posted
January 13, 2014
Study Start
March 1, 2015
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
February 4, 2015
Record last verified: 2015-02