This trial is active, not recruiting.

Condition androgenetic alopecia
Treatment gid svf-2
Sponsor The GID Group
Start date December 2015
End date February 2017
Trial size 8 participants
Trial identifier NCT02626780, GIDAA-01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Autologous adipose-derived SVF will be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia.
gid svf-2
Comparison of the number and thickness of hair before and after treatment of autologous adipose-derived SVF.

Primary Outcomes

Incidence of treatment-emergent adverse events (safety)
time frame: 6 months

Secondary Outcomes

Growth of new hair
time frame: 6 months
Change in hair thickness
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: 1. Males and females 18 - 60 years of age and older that have been diagnosed with androgenetic alopecia. 2. 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 3. Able and willing to make the required study visits. 4. Able and willing to give consent and follow study instructions. 5. Must speak, read and understand English Exclusion Criteria: 1. History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days prior to injection 2. Allergic to lidocaine, epinephrine, valium or sodium phosphate 3. Individuals with a propensity for keloids 4. Individuals with diminished decision-making capacity will not be included in this research study 5. 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. 6. 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. 7. All smokers and other tobacco users.

Additional Information

Official title Adipose-derived Stromal Vascular Fraction (SVF) Injections to Stimulate Hair Regrowth for Androgenetic Alopecia
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by The GID Group.