Autologous hair follicle secretome treatment for androgenic alopecia

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

This will test whether injecting a person's own hair-follicle secretome into the scalp can help adults with androgenic alopecia grow thicker, denser hair.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Acorn Biolabs Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation, methotrexate, prednisone
• Locations: 1 site (West Hollywood, California)
• Trial ID: NCT07107841 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled single-site trial enrolls 60 adults with androgenic alopecia who are on a stable regimen of minoxidil and/or 5-alpha reductase inhibitors. Participants receive injections of autologous hair follicle-derived secretome or placebo at baseline and on days 30, 90, 180, 270 and 365, with each affected scalp quadrant receiving a vial diluted in saline and ~20 grid-pattern injections per quadrant. Outcomes include quantitative hair density and thickness measurements and patient-reported outcomes, and the product's proteomic profile is noted to contain higher concentrations of bioactive components than matched PRP. The protocol is designed to detect safety signals and clinical hair regrowth over a one-year treatment and follow-up period.

Who should consider this trial

Good fit: Adults aged 18–65 with androgenic alopecia who have been on a stable course of topical or oral minoxidil and/or 5-alpha reductase inhibitors (with no planned changes) and who can attend multiple injection visits over one year.

Not a fit: People with non-androgenic causes of hair loss, those not on a stable hair-growth regimen as required, or individuals outside the 18–65 age range are less likely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the treatment could produce thicker, denser hair using a personalized product made from the patient's own hair follicles.

How similar studies have performed: Related biologic approaches such as platelet-rich plasma have shown mixed but sometimes positive hair-regrowth results, while autologous hair follicle-derived secretome is a newer approach with limited clinical data to date.

Eligibility criteria

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

Where this trial is running

West Hollywood, California

• Ziering Medical — West Hollywood, California, United States (Recruiting)

Study contacts

• Study coordinator: Lisa M Campbell, PhD

Conditions Androgenic Alopecia; Alopecia; Baldness; secretome; alopecia; Hair; stem cells; androgenic