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Adipose Derived Stem Cells in Facial Fat Grafting (SVF)

Primary Purpose

Facial Atrophy

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Stromal Vasular Fraction

Biopsy

About this trial

This is an interventional treatment trial for Facial Atrophy focused on measuring Facial Atrophy, Autologous, Adult, Adipose Derived Stem Cells, Stromal Vascular Fraction, Collagenase

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Female or Male, Age 18 to 70 years old
Subjects that are eligible for liposuction and facial fat grafting procedures for cosmetic purposes and facial atrophy.
Subjects must require augmentation to the infra-malar region. Furthermore, facial engraftment to additional, non-study related regions is optional, but not required.
Inframalar Atrophy Assessment Scale of 2 to 4
Facial volume defect range: 2 to 10 mL
Body Mass Index (BMI) between and including 22 and 29
Able to understand and provide written and verbal informed consent
Fitzpatrick Scale 1 to 6

Exclusion Criteria:

Currently taking or have taken None Steroid Anti-inflammatory Drugs (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 (e.g. cervical cancer)
- Active infection
- Type I or Type II Diabetes
- Skin/Bone deformities in the face, including scaring or hyperpigmentation within the graft site.
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
Dermal fillers or facial reconstruction within the past 24 months, Subjects must also refrain from such procedures during the duration of the study.
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
Taking strong CYP450 inhibitors
Subjects with a history of keloids or hypertrophic scar formations
Previous treatment with any synthetic fillers in the inframalar area

Sites / Locations

Delmont Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stromal Vascular Fraction

Biopsy for Control -regular fat transfer

Arm Description

Subjects will receive stromal vascular fraction assisted fat transfer.

Subjects will receive regular fat transfer. A biopsy procedure will analyzes the different between experimental and control groups.

Outcomes

Primary Outcome Measures

Volume retention

To demonstrate that SVF administration, in concert with autologous facial fat grafts, is more efficacious, with regards to graft survival, than standard, non-SVF enhanced, autologous facial fat grafts

Secondary Outcome Measures

Number of Participants ith autologous facial fat grafts via laboratory results

To monitor the safety of SVF administration along with autologous facial fat grafts via laboratory results

Changes in the quality of skin

a blinded and independent investigator will assess any changes to the quality of skin

Full Information

NCT ID

NCT02526576

First Posted

August 11, 2015

Last Updated

February 25, 2019

Sponsor

Antria

1. Study Identification

Unique Protocol Identification Number

NCT02526576

Brief Title

Adipose Derived Stem Cells in Facial Fat Grafting

Acronym

SVF

Official Title

A Phase II Double-blind, Randomized, Study to Assess the Efficacy of Facial Fat Grafts Supplemented With Autologous, Adipose Derived Stromal Vascular Fraction (SVF)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

August 2015 (Actual)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Antria

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This phase two, randomized, double-blind study is designed to demonstrate the enhanced efficacy of SVF-enriched autologous facial fat grafts, in relation to standard, non-SVF enriched, facial fat grafts by evaluating volumetric retention and contour of the engrafted region over the course of one year.

Detailed Description

Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large therapeutic potential for many rare and common diseases that impacts millions of patients worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to extract with minimally invasive procedures such as elective liposuction in large quantities and therefore may be a cost effective source for cellular therapies in a wide range of medical specialties. The term "Facial Atrophy" describes the lost of subcutaneous fat within the face and can be a result of the aging process as well as some pathological diseases. It can be corrected via autologous fat transfer but usually the majority of the grafted cells will die after 6-12 months. Several publications demonstrate that the addition of SVF cells to the graft may enhance the graft survival. This double blind, randomized study aims to demonstrated the efficacy of Antria Cell Preparation Process in autologous facial fat grafting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Facial Atrophy

Keywords

Facial Atrophy, Autologous, Adult, Adipose Derived Stem Cells, Stromal Vascular Fraction, Collagenase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stromal Vascular Fraction

Arm Type

Experimental

Arm Description

Subjects will receive stromal vascular fraction assisted fat transfer.

Arm Title

Biopsy for Control -regular fat transfer

Arm Type

Active Comparator

Arm Description

Subjects will receive regular fat transfer. A biopsy procedure will analyzes the different between experimental and control groups.

Intervention Type

Biological

Intervention Name(s)

Stromal Vasular Fraction

Other Intervention Name(s)

Stromal Vascular Fraction, Adiployx

Intervention Description

The stromal vascular fraction obtained from adipose tissue will be added to the graft

Intervention Type

Procedure

Intervention Name(s)

Biopsy

Intervention Description

A subgroup of each arm (2 subjects from each arm) will undergo a fat transfer behind each ear to be removed via biopsy after 12 months

Primary Outcome Measure Information:

Title

Volume retention

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Number of Participants ith autologous facial fat grafts via laboratory results

Description

To monitor the safety of SVF administration along with autologous facial fat grafts via laboratory results

Time Frame

36 months

Title

Changes in the quality of skin

Description

a blinded and independent investigator will assess any changes to the quality of skin

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female or Male, Age 18 to 70 years old Subjects that are eligible for liposuction and facial fat grafting procedures for cosmetic purposes and facial atrophy. Subjects must require augmentation to the infra-malar region. Furthermore, facial engraftment to additional, non-study related regions is optional, but not required. Inframalar Atrophy Assessment Scale of 2 to 4 Facial volume defect range: 2 to 10 mL Body Mass Index (BMI) between and including 22 and 29 Able to understand and provide written and verbal informed consent Fitzpatrick Scale 1 to 6 Exclusion Criteria: Currently taking or have taken None Steroid Anti-inflammatory Drugs (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 (e.g. cervical cancer) Active infection Type I or Type II Diabetes Skin/Bone deformities in the face, including scaring or hyperpigmentation within the graft site. 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 Dermal fillers or facial reconstruction within the past 24 months, Subjects must also refrain from such procedures during the duration of the study. 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 Taking strong CYP450 inhibitors Subjects with a history of keloids or hypertrophic scar formations Previous treatment with any synthetic fillers in the inframalar area

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shahram Rahimian, MD

Organizational Affiliation

Antria

Official's Role

Study Director

Facility Information:

Facility Name

Delmont Surgery Center

City

Delmont

State/Province

Pennsylvania

ZIP/Postal Code

15601

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.antria.org

Description

Sponsor's website

URL

http://artisan-plasticsurgery.com/

Description

Site's website

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Adipose Derived Stem Cells in Facial Fat Grafting

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