Adipose-derived SVF for Treatment of Alopecia

GID BIO

Status: Completed

Conditions: Androgenetic Alopecia

Treatments: Device: GID SVF-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02626780

GIDAA-01

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

SVF Injection

Experimental group

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.

Treatment:

Device: GID SVF-2