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

checkorphan
Learn more about:
Lipodystrophy
Related Clinical Trial
Safety and Efficacy of Injectable Poly-L-Lactic Acid for Volume Loss in the Temples Using Dual Plane Injections Exploratory Study of the Relationships Between the Biomarkers of Inflammation, Lipidome and Insulin Resistance and Disorders of Glycemic Regulation in a Cohort of Insulin-resistant Subjects Due to Excess Weight or Dunnigan’s Lipodystrophy Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy Intraoperative Fluid Management of Liposuction , Cardiometry Versus Rohrich Formula The Visceral Adiposity Measurement and Observation Study Evaluating the Performance and Safety of the Medical Device Plenhyage® in the Treatment of Dermal Tissue Defects Evaluating the Performance and Safety of the Medical Device Auralya® in the Treatment of Facial Dermal Tissue Defects Evaluating the Performance and Safety of the Medical Device Janesse in the Treatment of Facial Dermal Tissue Defects Evaluating Performance and Safety of the Medical Device Jalucomplex in the Treatment of Facial and Neck Tissue Defects Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH. Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome Exercise and Pioglitazone for HIV-Metabolic Syndromes Observational Study of Changes in Fat Distribution and Blood Metabolites in HIV Infected Adults Yoga for the Management of HIV-Metabolic Syndromes Pravastatin for Hyperlipidaemia in HIV. A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth Exercise for Patients With HIV Infections Lactate Metabolism Study in HIV Infected Persons Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients With Insulin and Fat Abnormalities Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients Safety Study of Antria Cell Preparation Process to Enhance Facial Fat Grafting With Adipose Derived Stem Cells Growth Hormone Dynamics and Cardiac Steatosis in HIV The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers Detraining in People Living With HIV/AIDS SHARE: Simple HAART With Abacavir, Reyataz, and Epivir The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS Observational Study of Fat Loss in HIV Infected Adults Taking Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Metabolism and Body Shape of Healthy Children and Children With Chronic Infections Changing to Nonprotease Inhibitor Treatment to Improve Side Effects Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids Perceived Changes in Body Build and Image in Patients Who Are Now Taking or Recently Have Stopped Taking Anti-HIV Drugs White Light Scanning to Aid Body Contouring: A Pilot Project Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy The Cleveland Cardiometabolic Cohort Metabolic Abnormalities in HIV-infected Persons Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients. Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome Effects of Short-term Growth Hormone in HIV-infected Patients Safety Study of Filler Agent Composed of Autologous Mesenchymal Stem Cells and Hyaluronic Acid Raltegravir Therapy for Women With HIV and Fat Accumulation The PREFORM Study: A Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring Effects of IGF-I in HIV Metabolic Disease Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy Effects of Growth Hormone Releasing Hormone in HIV A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy Body Composition and Adipose Tissue in HIV Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue CONFORM: Rotational Fractional Resection for Submental Contouring Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy TH9507 in Patients With HIV-Associated Lipodystrophy TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy Energy Expenditure of People Living With HIV/AIDS Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS) Egrifta Replacement and Sleep Disordered Breathing Clinical Trial to Determine the Efficacy of Sculptraâ„¢ Dermal Filler for the Correction of Contour Deformities Caused by Lipoatrophy Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients Low Energy Diet and Familial Partial Lipodystrophy Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy Adipocyte, Insulin-resistance and Immunity : Evaluation of Interleukin-7 in Lipodystrophy, Diabetes and Obesity Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy Role of the Autonomic Nervous System in HIV-Lipodystrophy Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome Therapeutic Approaches to HAART-Induced Lipodystrophy Different Surgical Modalities for Thigh Lipodystrophy Including Liposuction,Thigh Lift and Liposuction Assisted Thigh Lift Leptin to Treat Lipodystrophy Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy Prevalence of Lipodystrophy Syndrome and Its Role as Cause of Metabolic Disturbances Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat Corticosteroid-induced Lipodystrophy and Adipokines Short-term Effects of Leptin in People With Lipodystrophy Leptin to Treat Lipodystrophy Lipodystrophy Connect Patient Registry An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy

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