Hair Follicle Secretome for Male Pattern Baldness

Overseen By Lisa M Campbell, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Acorn Biolabs Inc.

Must be taking: Minoxidil, 5-alpha reductase inhibitors

Must not be taking: Anticoagulants, NSAIDs, Vitamin E, others

Disqualifiers: Alopecia areata, Scalp infection, Autoimmune, others

Compensation: Varies

Number of Visits: 6

Duration: 52 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a treatment derived from a person's own hair follicles can safely and effectively enhance hair growth in individuals with androgenic alopecia, commonly known as male pattern baldness. Participants will receive injections of the treatment, called Autologous Hair Follicle Secretome, into their scalp at various intervals. Researchers will measure changes in hair density and thickness. Individuals who have used a stable combination of minoxidil (a hair growth treatment) and 5-alpha reductase inhibitors for at least six months, and are willing to maintain their current hair care routine, might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in hair restoration.

Do I have to stop taking my current medications for the trial?

You must continue taking your current medications, specifically minoxidil and 5-alpha reductase inhibitors, as you need to have been on them for at least 6 months before starting the trial and cannot change them during the study. However, if you use nonsteroidal anti-inflammatory drugs or Vitamin E daily, you must stop 7 days before the first treatment and only use them as needed during the trial.

What prior data suggests that this treatment is safe for male pattern baldness?

Research has shown that stem cell-based therapies, such as the autologous hair follicle secretome, are generally safe and effective for improving hair growth in individuals with male pattern baldness. Studies have found these treatments to be well-tolerated, with few side effects reported. The secretome, derived from a person's own hair follicles, reduces the risk of rejection or severe reactions. While the specific study on this secretome is still assessing its safety, earlier research supports its safe use in similar treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for male pattern baldness, which often include medications like minoxidil or finasteride, the autologous hair follicle secretome focuses on harnessing the body's own resources. This treatment is unique because it uses secretomes derived from a patient's own hair follicles, potentially reducing the risk of side effects associated with synthetic drugs. Researchers are excited about this approach as it represents a shift towards personalized medicine, where the treatment is tailored to the individual's biology, potentially leading to more effective and natural hair regrowth. The use of a patient's own biological material could also improve compatibility and acceptance by the body, offering a promising alternative to current therapies.

What evidence suggests that this treatment might be an effective treatment for male pattern baldness?

Research has shown that using a person's own hair follicle secretions can improve hair growth in individuals with androgenetic alopecia. In this trial, participants will receive either the autologous hair follicle-derived secretome or a placebo control. Studies have found that both cell-based and cell-free stem cell treatments are safe and can increase hair growth and thickness. Early results suggest that repeated injections of these secretions stimulate hair regrowth. Specifically, another study using a similar treatment reported noticeable improvements in hair loss. These findings support its potential effectiveness in treating male pattern baldness. ^{1 2 6 7 8}

Who Is on the Research Team?

Lisa M Campbell, PhD

Principal Investigator

Acorn Biolabs

Are You a Good Fit for This Trial?

This trial is for individuals experiencing male pattern baldness. Participants will receive injections of a substance derived from their own hair follicles to see if it improves hair density and thickness.

Inclusion Criteria

Subjects with Androgenic alopecia

I can attend all required study visits.

I am aware of the gender-specific participant limits for this trial.

Exclusion Criteria

Any health condition that in the investigator's opinion should preclude participation in this study

Cuts or abrasions on the scalp

I have active psoriasis or severe seborrheic dermatitis on my scalp.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of autologous hair follicle-derived secretome or placebo at baseline, and days 30, 90, 180, 270, and 365

52 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Hair Follicle Secretome

Trial Overview The study tests an autologous hair follicle-derived secretome against a placebo. Injections are given at the start and then after 30, 90, 180, 270, and 365 days. Hair growth and participant-reported outcomes (PROs) are measured throughout.

How Is the Trial Designed?

Group I: Active-Secretome Active Control 1 Intervention

Intervention is autologous hair follicle-derived secretome diluted in saline

Group II: Placebo Control Placebo Group 1 Intervention

Placebo control is saline.

Who Is Running the Clinical Trial?

Acorn Biolabs Inc.

Lead Sponsor

Trials

3

Recruited

650+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10863936/

Autologous Stem Cell-derived Therapies for Androgenetic ... Both cellular and acellular stem cell–based therapies are safe and effective in improving hair regeneration and density in AGA patients.

2. clinicaltrial.be clinicaltrial.be/en/details/556839?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Autologous Hair Follicle Secretome for Androgenic Alopeci... The hypothesis is that repeat injections of autologous hair follicle-derived secretome will safely and effectively stimulate hair regrowth in ...

3. asgct.careboxhealth.com asgct.careboxhealth.com/en-US/trial/listing/635136

Autologous Hair Follicle Secretome for Androgenic Alopecia The purpose of this clinical trial is to evaluate the safety and efficacy of the use of an autologous hair follicle derived secretome for ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962220302723

Autologous cell–based therapy for male and female pattern ... This is a clinical study reporting a cell-based treatment for hair loss using autologous DSC cells that shows a significant result.

5. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-025-04372-9

Hair growth stimulated by allogenic adipose-derived stem ... Stem cells from human hair follicles: first mechanical isolation for immediate autologous clinical use in androgenetic alopecia and hair loss.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01286649

Safety and Efficacy Study of Human Autologous Hair ... The primary purpose of this study is to assess the safety of performing injections of human autologous hair follicle cells.

7. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-024-03801-5

Clinical and preclinical approach in AGA treatment: a review ... Although male AGA etiology is well known to be caused by DHT action in hair follicles, female AGA is related to a huge range of trigger factors, ...

8. withpower.com withpower.com/trial/phase-alopecia-8-2025-00f04

Hair Follicle Secretome for Male Pattern Baldness (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 ...