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Stem cell shot into ovaries aims to tame perimenopause symptoms

NCT ID NCT07511660

Disease control Sponsor: Healing Hope International Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at whether injecting special stem-like cells called Muse cells directly into the ovaries can help women aged 28 to 70 who are in perimenopause. The cells may repair tissue, reduce inflammation, and improve hormone balance. Researchers will track safety, hormone levels, and quality of life for 24 months. The goal is to see if this approach can ease symptoms like hot flashes and mood changes without long-term medication.

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.

Participants

About 12 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

This is a prospective observational cohort study using convenience sampling. Participants are women aged 28-70 experiencing perimenopause who independently elect to receive ultrasound guided intra ovarian Muse cell injection as part of their routine clinical regenerative medicine care at the study center. No random sampling, probability based recruitment, or protocol-mandated intervention assignment occurs. Enrollment is open to eligible women who present seeking regenerative options for perimenopausal symptoms and ovarian support. The sampling approach reflects real world clinical practice, allowing collection of standardized longitudinal data on safety and outcomes in a self selected population. Potential selection bias toward motivated individuals interested in regenerative therapies is acknowledged and will be addressed through transparent reporting and subgroup analyses.

Ages

28 to 70 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 to 70 years at the time of enrollment. Diagnosis of perimenopause according to STRAW+10 criteria, including irregular menstrual cycles (cycle length variation \>7 days), elevated FSH (\>25 IU/L on two occasions), low AMH (\<1.0 ng/mL), and/or presence of perimenopausal symptoms (vasomotor symptoms, sleep disturbance, mood changes, or cognitive complaints). Willingness to receive ultrasound-guided intra-ovarian Muse cell injection as part of elective clinical regenerative medicine care. Ability to provide written informed consent and comply with scheduled follow-up visits, blood draws, ultrasounds, and questionnaires for 24 months. Adequate general health to undergo the procedure under sedation or local anesthesia, as determined by the treating physician. Exclusion Criteria: History of ovarian/gynecologic malignancy (active or \<5 years remission). Active autoimmune disease requiring immunosuppression. Uncontrolled comorbidities (e.g., severe cardiovascular disease, coagulopathy, uncontrolled diabetes or thyroid disease). Current pregnancy or lactation. Recent hormone therapy (within 3 months). BMI \>40 kg/m² or other factors increasing procedural risk. Inability to comply with study procedures.

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Conditions

The condition(s) this trial relates to.

endocrine system disorder Hot Flashes multiple endocrine neoplasia type 1 ovarian dysfunction premature menopause primary ovarian failure

As listed by the trial registrant

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

Cell therapy Diminished ovarian reserve Diminished ovarian reserve (DOR) Diminished ovarian reserve due to advanced maternal age Hormonal imbalance Hormone disturbance Menopause Menopause hot flashes Menopause ovarian failure Ovarian dysfunction Perimenopause Perimenopause-related depression Premature ovarian failure Premature ovarian failure (POF) Premature ovarian insufficiency Quality of life Quality of life and menopause Vasomotor symptoms Vasomotor symptoms (VMS) Vasomotor symptoms as A sex hormone-dependent disorder in women and men Vasomotor symptoms associated with menopause Womens health

How to take part

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

  1. The places running it

    1 site. 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

  • Stem Solutions

    Monterrey, Nuevo León, 64000, Mexico

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