Brief Title
Safety Study of Filler Agent Composed of Autologous Mesenchymal Stem Cells and Hyaluronic Acid
Official Title
Phase I Study of a Filler Agent Composed of Mesenchymal Stem Cells Obtained From Autologous Adipose Tissue Associated With Hyaluronic Acid
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.
Detailed Description
Open, controlled and randomized study. The intervention performed in this study will be the transdermal injection of the filler agent in patients undergoing elective cosmetic liposuction procedure, with legal age and without any of the exclusion criteria items. Patients will be evaluated according to the parameters for a total period of 12 months. Individuals in the control group will have transdermal injection of hyaluronic acid and will be evaluated with the same parameters used for the study group and also for the same period. In this study, 25 volunteers attended at Dermatologic Service of the Bonsucesso Federal Hospital (HFB) will be included. The research subjects will be evaluated preliminarily regarding inclusion and exclusion criteria of the study and the procedure will only be performed after the signing of the Informed Consent Form (ICF). The efficacy and safety study will be conducted following Good Laboratory and Clinics Practices. Patients who meet the study eligibility criteria will be randomly assigned to one of the two treatment groups: Test or Control. The first follow-up visit will occur in the first month post-procedure. Subsequent consultations will be held at 3, 6 and 12 months after the procedure.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Adverse Events Analysis
Secondary Outcome
Efficacy Analysis
Condition
Lipodystrophies
Intervention
Adipose tissue collection
Study Arms / Comparison Groups
Test
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
25
Start Date
March 2015
Completion Date
June 2016
Primary Completion Date
May 2016
Eligibility Criteria
Inclusion Criteria: - 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. Exclusion Criteria: - 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Paulo RC Souza, M.D, +55212561-0182, [email protected]
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT02034786
Organization ID
Cryo 394.191
Secondary IDs
394.191
Responsible Party
Sponsor
Study Sponsor
Cryopraxis Criobiologia Ltda.
Collaborators
Hospital Federal de Bonsucesso
Study Sponsor
Paulo RC Souza, M.D, Principal Investigator, Dermatology Service
Verification Date
February 2015