Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site)

Blinded, Randomized, Controlled, Trial to Evaluate the Efficacy and Safety of Autologous Hair Follicle Secretome for the Treatment of Androgenic Alopecia (Single Site)

(SINGLE SITE Study) The purpose of this clinical trial is to evaluate the safety and efficacy of the use of an autologous hair follicle derived secretome for androgenous alopecia. The secretome will be injected into the scalp at baseline, and days 30, 90, 180, 270 and 365.

Hair growth will be quantitatively measured for density and thickness. PROs will also be collected from participants. This study will be run at a SINGLE SITE.

(SINGLE SITE Study) Androgenic alopecia is a common condition causing hair loss and baldness in both men and women. Approximately 80 million men and women are affected by the condition in the US alone. Although there are a number of products on the market, both over the counter and prescribed, used for androgenic alopecia, they are only somewhat effective to slow the progression.

This trial will evaluate a new approach involving the injection of an autologous product made from the cellular secretions of hair follicles (secretome). Proteonomic analysis has demonstrated that this secretome contains anywhere from 2-22 times the bioactive components of platelet rich plasma (PRP) when compared within the same individual. The hypothesis is that repeat injections of autologous hair follicle-derived secretome will safely and effectively stimulate hair regrowth in men and women suffering from androgenic alopecia.

The trial is a double-blind, randomized, placebo controlled study in 60 patients who are on a stable (>6 months) regimen of minoxidil and 5 alfa-reductase inhibitors. The injections will be delivered at baseline (day 0), 30, 90, 180, 270 and 365 days as follows:

• Each vial of secretome will be diluted with 2ml of saline
• Each quadrant of the affected scalp will receive one vial of secretome
• Injections will be delivered in a grid-like pattern with injections spaced ~1cm apart
• Approximately 20 injections (0.1ml/injection) will be delivered to each alopecia affected quadrant

Inclusion Criteria

• SUBJECTS MUST BE ON A STABLE COURSE OF MINOXIDIL (ORAL OR TOPICAL) AND/OR 5-ALPHA REDUCTASE INHIBITORS. THEY MUST HAVE BEEN ON THE SAME 5-ALPHA REDUCTASE INHIBITOR FOR ≥12 MONTHS PRIOR TO BASELINE.
• FEMALE SUBJECTS MUST NOT BE ON HAIR GROWTH MEDICATIONS OR TOPICALS FOR ≥6 MONTHS PRIOR TO BASELINE.
• TESTOSTERONE REPLACEMENT THERAPY (TRT) IN ANY FORM (E.G. DEPO-, INJECTABLE, TOPICAL, PATCHES, NASAL GEL, ORAL, PELLET ETC.) IS ALLOWED AS LONG AS SUBJECT HAS BEEN ON A STABLE COURSE (IN THE OPINION OF THE INVESTIGATOR) OF TRT FOR ≥12 MONTHS.
• Biological sex: Male and Female (up to n=20 males and up to n=10 females will be in each arm for a total of up to n=40 males and up to n=20 females)
• Age: ≥18 - 65 years
• Subjects with Androgenic alopecia
• No intention to start new hair growth medications and no intention to change the dosage or usage of minoxidil or 5-alpha reductase inhibitors until the end of their participation in the trial.
• Competent and willing to provide written, informed consent to participate in all study activities.
• Willing and able to tolerate multiple injections of the study product.
• Must be able to attend all study related clinical visits.
• Willing to maintain the same hair style as at the Screening Visit for the duration of the study.
• Must be willing to have small (diameter similar to a pencil lead) UV (invisible) or red colored tattoo dots applied to scalp (up to 5) and touch up tattoos if necessary. UV tattoo dots only show under black light. Subjects will chose UV or red.

Exclusion Criteria

• Subjects with clinical diagnosis of alopecia areata or other non-androgenic forms of alopecia.
• Active skin disease (Psoriasis or severe seborrheic dermatitis) of the scalp
• Scalp infection
• Severe active systemic infection
• Cuts or abrasions on the scalp
• History of surgical hair restoration in the last 12 months.
• Current or recent (within last 5 years) malignancy (except basal cell and squamous cell skin cancers)
• History of systemic chemotherapy or radiation
• History of thyroid dysfunction
• History of autoimmune disorder (specifically Graves disease, Hashimoto thyroiditis, or systemic lupus erythematosus)
• Continuous/daily use of nonsteroidal anti-inflammatory or Vitamin E, unless discontinued within 7 days before 1st treatment and only used as needed through the trial period.
• Use of any medications that potentially cause drug-induced hair loss (e.g., depo-testosterone, haloperidol, methotrexate, methylprednisolone, prednisone, testosterone, divalproex sodium) within the last 3 months.
• Known allergy or sensitivity to tattoo ink.
• Current anticoagulant therapy (heparins; factor Xa inhibitors; direct agents such dabigatran, rivaroxaban, apixaban, edoxaban and betrixaban; warfarin/coumarins)
• Significant tendency to develop keloids or hypertrophic scarring
• Subjects unable to communicate with the investigator and staff
• Any health condition that in the investigator's opinion should preclude participation in this study