Back to resultsAdipose-derived SVF for Treatment of Alopecia
Primary Purpose
Androgenetic Alopecia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GID SVF-2
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia
Eligibility Criteria
Inclusion Criteria:
- Males and females 18 - 60 years of age and older that have been diagnosed with androgenetic alopecia.
- Subjects will be in good health (ASA Class I-II) with a BMI < 35. Must have at least a 2cm x 2cm spot on the scalp which shows evidence of alopecia without scarring or traumatic injury
- Able and willing to make the required study visits.
- Able and willing to give consent and follow study instructions.
- Must speak, read and understand English
Exclusion Criteria:
- History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days prior to injection
- Allergic to lidocaine, epinephrine, valium or sodium phosphate
- Individuals with a propensity for keloids
- Individuals with diminished decision-making capacity will not be included in this research study
- Current use of anti-inflammatory or anticoagulation medications that affect bleeding or are for bleeding disorders. These include: Plavix, Warfarin (Coumadin, Jantoven, Marfarin). In addition, if any of the following medicines are used two (2) weeks prior to surgery the patient will be ineligible.
- Use of concomitant treatments, including topical medications, oral medications, meso-therapy, non-ablative fractional laser treatment, low-level laser therapy, interfollicular PRP injection and hair transplantation within the preceding 6 months.
- All smokers and other tobacco users.
Sites / Locations
- Maxwell Aesthetics
- Renew Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SVF Injection
Arm Description
Liposuction of a small amount of adipose tissue will be taken from each subject. Stromal Vascular Fraction (SVF) will be disassociated within the GID SVF-2 from the autologous adipose tissue to be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia.
Outcomes
Primary Outcome Measures
Incidence of Treatment-emergent Adverse Events (Safety)
Subjects will be monitored for Adverse events for the duration of the study.
Secondary Outcome Measures
Growth of New Hair
The change in hair density (number of hairs per square centimeter) from baseline to 6 months after treatment will be expressed as a percentage.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02626780
Brief Title
Adipose-derived SVF for Treatment of Alopecia
Official Title
Adipose-derived Stromal Vascular Fraction (SVF) Injections to Stimulate Hair Regrowth for Androgenetic Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 20, 2016 (Actual)
Primary Completion Date
January 22, 2017 (Actual)
Study Completion Date
January 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GID BIO, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The general objective of this study is to conduct a safety and feasibility study of a single injection of autologous adipose-derived SVF for the treatment of alopecia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SVF Injection
Arm Type
Experimental
Arm Description
Liposuction of a small amount of adipose tissue will be taken from each subject. Stromal Vascular Fraction (SVF) will be disassociated within the GID SVF-2 from the autologous adipose tissue to be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia.
Intervention Type
Device
Intervention Name(s)
GID SVF-2
Intervention Description
Comparison of the number of hairs before and after treatment of autologous adipose-derived SVF as a percentage increase or decrease in growth.
Primary Outcome Measure Information:
Title
Incidence of Treatment-emergent Adverse Events (Safety)
Description
Subjects will be monitored for Adverse events for the duration of the study.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Growth of New Hair
Description
The change in hair density (number of hairs per square centimeter) from baseline to 6 months after treatment will be expressed as a percentage.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females 18 - 60 years of age and older that have been diagnosed with androgenetic alopecia.
Subjects will be in good health (ASA Class I-II) with a BMI < 35. Must have at least a 2cm x 2cm spot on the scalp which shows evidence of alopecia without scarring or traumatic injury
Able and willing to make the required study visits.
Able and willing to give consent and follow study instructions.
Must speak, read and understand English
Exclusion Criteria:
History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days prior to injection
Allergic to lidocaine, epinephrine, valium or sodium phosphate
Individuals with a propensity for keloids
Individuals with diminished decision-making capacity will not be included in this research study
Current use of anti-inflammatory or anticoagulation medications that affect bleeding or are for bleeding disorders. These include: Plavix, Warfarin (Coumadin, Jantoven, Marfarin). In addition, if any of the following medicines are used two (2) weeks prior to surgery the patient will be ineligible.
Use of concomitant treatments, including topical medications, oral medications, meso-therapy, non-ablative fractional laser treatment, low-level laser therapy, interfollicular PRP injection and hair transplantation within the preceding 6 months.
All smokers and other tobacco users.
Facility Information:
Facility Name
Maxwell Aesthetics
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Renew Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Adipose-derived SVF for Treatment of Alopecia
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