Intra Ovarian Muse Cell Injection for Perimenopause Symptom Relief and Ovarian Function Restoration (MUSE-OVARY)

What this trial studies

This observational study examines the safety and effects of injecting Muse cells (a type of naturally occurring stem like cells found in adult tissues such as fat or bone marrow) directly into the ovaries of women aged 28 to 70 who are going through peri-menopause. Perimenopause is the transition time before menopause when hormone levels fluctuate, periods become irregular, and many women experience symptoms like hot flashes, night sweats, sleep problems, mood changes, and reduced energy. Current treatments mainly manage symptoms but do not restore natural ovarian function. Muse cells have special properties: they can help repair tissues, reduce inflammation, support cell energy production, and promote a healthier environment in the ovaries.

Conditions in scope

• Perimenopause
• Perimenopause-Related Depression
• Premature Ovarian Insufficiency
• Premature Ovarian Failure (POF)
• Premature Ovarian Failure
• Menopause
• Menopause Hot Flashes
• Menopause Ovarian Failure

Interventions

• Not specified in the public record.

Who can join

Women only · Ages 28 Years to 70 Years

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Enrolling by invitation
• Study type: Observational
• Phase: N/A
• Start date: 2026-06-01
• Primary completion: 2028-01-01
• Last update posted: 2026-04-06
• First posted: 2026-04-06

Sponsor & contact

Lead sponsor: Healing Hope International (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Incidence of Adverse Events and Serious Adverse Events (From baseline through 36 months post procedure, with focused monitoring in the first 30 days.)
  Safety and tolerability of ultrasound-guided intra-ovarian Muse cell injection, assessed by the incidence, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.