Adipose-derived SVF for Treatment of Alopecia

Study Overview
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Brief Summary
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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.

Official Title
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Adipose-derived Stromal Vascular Fraction (SVF) Injections to Stimulate Hair Regrowth for Androgenetic Alopecia

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Device: GID SVF-2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SVF Injection<br>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. | Device: GID SVF-2<br>* Comparison of the number of hairs before and after treatment of autologous adipose-derived SVF as a percentage increase or decrease in growth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-emergent Adverse Events (Safety) | Subjects will be monitored for Adverse events for the duration of the study. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months |