Clinical trial NCT02034786: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Lipodystrophies
Aesthetics Procedure
Keywords: Mesenchymal stem cell
Hyaluronic acid
Adipose Tissue
Filler Agent
Lead sponsor: Cryopraxis Criobiologia Ltda.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Federal de Bonsucesso
First posted: 2014-01-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Adverse Events Analysis
timeFrame: Every visit over the first 12 months after intervention
Secondary outcomes:
measure: Efficacy Analysis
timeFrame: 1, 3, 6 and 12 months after the intervention
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Federal de Bonsucesso
Study officials:
affiliation: Dermatology Service
name: Paulo RC Souza, M.D
role: PRINCIPAL_INVESTIGATOR
References: