Aesthetics Procedure Clinical Trial
— LipAgeOfficial title:
Phase I Study of a Filler Agent Composed of Mesenchymal Stem Cells Obtained From Autologous Adipose Tissue Associated With Hyaluronic Acid
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.
| Status | Not yet recruiting |
| Enrollment | 25 |
| Est. completion date | June 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 ß-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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Hospital Federal de Bonsucesso | Rio de Janeiro |
| Lead Sponsor | Collaborator |
|---|---|
| Cryopraxis Criobiologia Ltda. | Hospital Federal de Bonsucesso |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | Efficacy Analysis | Difference of volume increase, captured by images, between control and study group at different times after the intervention (1, 3, 6 and 12 months). | 1, 3, 6 and 12 months after the intervention | No |