Adipose-derived SVF for Treatment of Alopecia

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
SVF Injection	GID SVF-2	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-emergent Adverse Events (Safety)	6 months	Subjects will be monitored for Adverse events for the duration of the study.

Secondary Outcome Measures

Name	Time	Method
Growth of New Hair	6 months	The change in hair density (number of hairs per square centimeter) from baseline to 6 months after treatment will be expressed as a percentage.