NCT01828723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

1.8 years

First QC Date

April 2, 2013

Last Update Submit

January 26, 2015

Conditions

LipoatrophyAgingWrinkles

Keywords

Autologous Adult Stem CellAdipose Derived Stem CellStromal Vascular FractionSVFAntriaShah RahimianLeonard MaliverDavid BizouskyRahul GoreLee QuistDudley McNitt

Outcome Measures

Primary Outcomes (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.

    6 months

Secondary Outcomes (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

    6 months

Study Arms (1)

SVF-Enriched Lipoinjection

EXPERIMENTAL
Biological: SVF

Interventions

SVFBIOLOGICAL
SVF-Enriched Lipoinjection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Currently taking or have taken NSAIDs within last two weeks or corticosteroids within the last six weeks prior to screening
  • 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
  • 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)
  • Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator
  • Subjects with major illnesses involving the renal, hepatic, cardiovascular, and/or nervous systems
  • Subjects with elevated kidney and/or liver functions
  • 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.
  • Subjects with life-expectancies less than 9 months
  • Subjects with known collagenase allergies
  • Subjects with idiopathic or drug-induced coagulopathy
  • Pregnant females
  • On radiotherapy or chemotherapy agents
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delmont Surgery Center

Greensburg, Pennsylvania, 15601, United States

Location

MeSH Terms

Conditions

Lipodystrophy

Condition Hierarchy (Ancestors)

Skin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Shahram Rahimian, MD, PhD

    Antria Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 11, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations

US(1)