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Safety Study of Antria Cell Preparation Process to Enhance Facial Fat Grafting With Adipose Derived Stem Cells

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.
 
ClinicalTrials.gov Identifier: NCT01828723
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
Antria

Study Description
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Brief Summary:
The primary purpose of this study is to demonstrate the safety of injecting the Stromal Vascular Fraction (SVF) [containing Adipose Derived Stem Cells (ADSCs)] enriched fat grafts into regions of the face that require enhancement. The safety of SVF will be evaluated throughout the course of the study phase through the assessment of laboratory values, physical examinations, adverse events, safety phone calls etc.

Condition or disease Intervention/treatment Phase
Lipoatrophy Aging Wrinkles Biological: SVF Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase One, Open Label, Single Arm Study to Demonstrate the Safety of Antria Cell Preparation Process During Facial Fat Grafting Assisted With Autologous, Adipose Derived Stromal Vascular Fraction (SVF)
Study Start Date : April 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: SVF-Enriched Lipoinjection Biological: SVF


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the safety of the administration of a concentrated SVF-enriched fat graft by monitoring the number and types of adverse events, and via physical examinations, vital signs, 12-lead ECGs, blood draws (CBC/LFT/BMP), and urinalysis. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. To demonstrate the efficacy of the addition of autologous SVF isolated via Antria Cell Preparation Process by observing graft survival time, volume, and quality of facial re-contouring [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female or Male, Age 18 years or older
  2. Subjects that are scheduled for liposuction and facial fat grafting procedures for cosmetic purposes
  3. Facial volume defects which could be treated with a total graft volume of between 1mL and 50mL
  4. BMI between and including 23 and 28
  5. Able to understand and provide written and verbal informed consent

Exclusion Criteria:

  1. Currently taking or have taken NSAIDs within last two weeks or corticosteroids within the last six weeks prior to screening

  2. Diagnosis of any of the following medical conditions:

    • Active malignancy (diagnosed within 5 years), except for treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm
    • Active infection
    • Type I or Type II Diabetes
  3. Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits, dementia, and/or otherwise considered by the Investigator to be unlikely to complete the study)
  4. Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator
  5. Subjects with major illnesses involving the renal, hepatic, cardiovascular, and/or nervous systems
  6. Subjects with elevated kidney and/or liver functions
  7. Any other disease condition or laboratory results that in the opinion of the investigator may be clinically significant and render the subject inappropriate for the study procedure(s), may alter the accuracy of study results, or increase risk for subjects.
  8. Subjects with life-expectancies less than 9 months
  9. Subjects with known collagenase allergies
  10. Subjects with idiopathic or drug-induced coagulopathy
  11. Pregnant females
  12. On radiotherapy or chemotherapy agents
  13. Taking strong CYP450 inhibitors such as protease inhibitors (ritonavir, indinavir, nelfinavir, saquinavir), macrolide antibiotics (clarithromycin, telithromycin), chloramphenicol, azole antibiotics (ketoconazole, itraconazole) and nefazodone.
  14. Subjects with a history of keloids or hypertrophic scar formations
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01828723


Locations
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United States, Pennsylvania
Delmont Surgery Center
Greensburg, Pennsylvania, United States, 15601
Sponsors and Collaborators
Antria
Investigators
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Principal Investigator: Shahram Rahimian, MD, PhD Antria Inc.
More Information
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Responsible Party: Antria
ClinicalTrials.gov Identifier: NCT01828723    
Other Study ID Numbers: SSVF0001
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015
Keywords provided by Antria:
Autologous Adult Stem Cell
Adipose Derived Stem Cell
Stromal Vascular Fraction
SVF
Antria
Shah Rahimian
 Leonard Maliver
David Bizousky
Rahul Gore
Lee Quist
Dudley McNitt
Additional relevant MeSH terms:
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Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases