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

January 26, 2015 updated by: Antria

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Greensburg, Pennsylvania, United States, 15601
        • Delmont Surgery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SVF-Enriched Lipoinjection
Biological: SVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antria

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (ESTIMATE)

April 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSVF0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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