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

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Brief Title

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

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)

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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

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.

Secondary Outcome

 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

Condition

Lipoatrophy

Intervention

SVF

Study Arms / Comparison Groups

 SVF-Enriched Lipoinjection
Description:

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

Biological

Estimated Enrollment

6

Start Date

April 2013

Completion Date

January 2015

Primary Completion Date

January 2015

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Shahram Rahimian, MD, PhD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01828723

Organization ID

SSVF0001

Responsible Party

Sponsor

Study Sponsor

Antria

Study Sponsor

Shahram Rahimian, MD, PhD, Principal Investigator, Antria Inc.

Verification Date

January 2015