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Safety Study of Filler Agent Composed of Autologous Mesenchymal Stem Cells and Hyaluronic Acid (LipAge)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02034786
Recruitment Status : Unknown
Verified February 2015 by Cryopraxis Criobiologia Ltda..
Recruitment status was:  Not yet recruiting
First Posted : January 13, 2014
Last Update Posted : February 4, 2015
Hospital Federal de Bonsucesso
Information provided by (Responsible Party):
Cryopraxis Criobiologia Ltda.

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.

Condition or disease Intervention/treatment Phase
Lipodystrophies Aesthetics Procedure Procedure: Adipose tissue collection Biological: Transdermal injection Procedure: Transdermal injection Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of a Filler Agent Composed of Mesenchymal Stem Cells Obtained From Autologous Adipose Tissue Associated With Hyaluronic Acid
Study Start Date : March 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Test
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.
Procedure: Adipose tissue collection

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.

Biological: Transdermal injection
Transdermal injection of the filler agent composed of mesenchymal stem cells derived from autologous adipose tissue associated with hyaluronic acid.

Active Comparator: Control
Transdermal injection of hyaluronic acid only.
Procedure: Transdermal injection
Transdermal injection of hyaluronic acid only.

Primary Outcome Measures :
  1. Adverse Events Analysis [ Time Frame: Every visit over the first 12 months after intervention ]
    Proportion of patients with non-serious and serious adverse events in the first 12 months after the intervention.

Secondary Outcome Measures :
  1. Efficacy Analysis [ Time Frame: 1, 3, 6 and 12 months after the intervention ]
    Difference of volume increase, captured by images, between control and study group at different times after the intervention (1, 3, 6 and 12 months).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02034786

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Contact: Paulo RC Souza, M.D +55212561-0182

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Hospital Federal de Bonsucesso
Rio de Janeiro, Brazil
Contact: Paulo RC Souza, M.D    +55212561-0182   
Principal Investigator: Paulo RC Souza, M.D         
Sponsors and Collaborators
Cryopraxis Criobiologia Ltda.
Hospital Federal de Bonsucesso
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Principal Investigator: Paulo RC Souza, M.D Dermatology Service

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Responsible Party: Cryopraxis Criobiologia Ltda. Identifier: NCT02034786    
Other Study ID Numbers: Cryo 394.191
394.191 ( Other Identifier: CEP )
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Keywords provided by Cryopraxis Criobiologia Ltda.:
Mesenchymal stem cell
Hyaluronic acid
Adipose Tissue
Filler Agent
Additional relevant MeSH terms:
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Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents