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Baldness breakthrough? own cells injected into scalp to regrow hair

NCT ID NCT07618195

Disease control Sponsor: Epibiotech Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new treatment called EPI-001 for androgenetic alopecia (common baldness). EPI-001 is made from a patient's own scalp cells and injected into the scalp. The trial has two parts: first, finding the safest dose in a small group, then comparing the best dose to a placebo in 42 people. Researchers will check for side effects and measure hair growth over up to 48 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EPI-001 (a cell-based injection made from the patient's own scalp cells)
What this could lead to
If it works, this could point toward a new treatment for male and female pattern baldness that uses a person's own cells to regrow hair.
What could go wrong
This is an early-phase trial with only 42 people, so it is too soon to know if it works. The treatment involves injections and may cause side effects like pain or swelling.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female subjects aged 19 years or older 2. Subjects diagnosed with androgenetic alopecia 3. Subjects willing to maintain the same hairstyle, hair length, and hair color during the study period 4. Subjects willing to refrain from prohibited hair-related products or procedures during the study period 5. Subjects willing to undergo scalp tattooing and hair trimming for phototrichogram evaluation 6. Subjects who voluntarily signed written informed consent Exclusion Criteria: 1. Subjects who used prohibited medications or therapies affecting hair growth within the protocol-defined period 2. Subjects with scalp diseases or hair disorders other than androgenetic alopecia 3. Subjects with autoimmune diseases affecting the scalp or hair 4. Subjects with clinically significant cardiovascular, renal, endocrine, infectious, or systemic diseases 5. Subjects positive for HBV, HCV, HIV, or syphilis screening tests 6. Subjects with a history of hair transplantation, stem cell therapy, or gene therapy 7. Subjects with hypersensitivity related to the investigational product or study procedures 8. Pregnant or breastfeeding women 9. Subjects who participated in another clinical study within the protocol-defined period 10. Subjects judged inappropriate for study participation by the investigator

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Conditions

The condition(s) this trial relates to.

alopecia androgenetic alopecia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Androgenetic alopecia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Chung-Ang University Hospital

    RECRUITING

    Seoul, Seoul, 06973, South Korea

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