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

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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