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

NCT07511660 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2026-04-06

No results posted yet for this study

Summary

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. In this study, women who choose to receive ultrasound guided Muse cell injections into their ovaries as part of their own regenerative care will be carefully followed.

Researchers will monitor safety, hormone levels (such as FSH, estrogen, and AMH), ovarian follicle counts via ultrasound, menstrual patterns, and quality of life improvements using questionnaires. The study does not assign treatment - participants and their doctors decide on the procedure, and information is collected in a standardized way over 24 months (with longer safety follow-up).

The goal is to gather real world data on whether this approach can help stabilize hormones and support ovarian tissue during perimenopause. No placebos or experimental drugs are used in this observational study.

Conditions

  • Perimenopause
  • Perimenopause-Related Depression
  • Premature Ovarian Insufficiency
  • Premature Ovarian Failure (POF)
  • Premature Ovarian Failure
  • Menopause
  • Menopause Hot Flashes
  • Menopause Ovarian Failure
  • Ovarian Dysfunction
  • Diminished Ovarian Reserve
  • Diminished Ovarian Reserve Due to Advanced Maternal Age
  • Diminished Ovarian Reserve (DOR)
  • Hormone Disturbance
  • Hormonal Imbalance
  • Quality of Life and Menopause
  • Quality of Life
  • Womens Health
  • Vasomotor Symptoms
  • Vasomotor Symptoms (VMS)
  • Vasomotor Symptoms Associated With Menopause
  • Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
  • Cell Therapy

Sponsors & Collaborators

  • Healing Hope International

    lead OTHER

Principal Investigators

  • Dr. Jonatha Leicher, MD: Regenerative Medicine · Healing Hope International

Eligibility

Min Age
28 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-01-01
Completion
2030-07-30

Countries

  • Mexico

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07511660 on ClinicalTrials.gov