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Could amniotic fluid help women regrow thinning hair?

NCT ID NCT07221773

Disease control Sponsor: Restore Biologics Holdings, Inc. dba Xtressé Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether a solution made from human amniotic fluid, called XVIE, can safely improve hair growth in women who feel their hair is thinning. Fifteen women will receive two treatments over four months, applied to the scalp via microneedling. Researchers will track changes in hair volume and thickness using photos and check for side effects.

What this could mean

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

Active substance
XVIE (human amniotic fluid derived nanoparticle solution)
What this could lead to
If it works, this could point toward a new treatment for hair thinning in women.
What could go wrong
This is a very small pilot study with only 15 women, so results may not apply to everyone. It's early-stage and not yet proven effective.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

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

Started

Sep 2025

Expected to finish

Feb 2027

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

28 to 65 years

Sex

Female participants only

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: * Women aged 28-65 years with self-perceived thinning hair (confirmed by an investigator). * Ludwig Scale 1 to 2 * Fitzpatrick skin types I to VI. * Ability and willingness to comply with the study protocol. * Commitment to using effective contraception throughout the study if of childbearing potential. Exclusion Criteria: * Pregnancy, nursing, or recent initiation of hormone therapy. * Change in other hair treatments within 3 months prior to the study. * Known uncontrolled health conditions (e.g., poorly controlled diabetes, hypertension). * History of hair or scalp disorders that could interfere with study results. * History of keloid formation or poor wound healing * History of bleeding and/or clotting disorders

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Conditions

The condition(s) this trial relates to.

alopecia

As listed by the trial registrant

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

Hair thinning

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

Locations

  • Advanced Dermatology & Cosmetic Surgery

    Maitland, Florida, 32751, United States

  • Kindred Hair & Skin Center

    Marriottsville, Maryland, 21104, United States

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