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

Sponsor
Healing Hope International
Study ID
NCT07511660
Status
Enrolling By Invitation

Conditions

  • 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 Associated With Menopause
  • Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
  • Womens Health

Eligibility Criteria

Sex
FEMALE
Age
28 Years - 70 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Apr 6, 2026
Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Jan 1, 2028
Completion
Jul 30, 2030

Study Design

Enrollment
12 participants (estimated)

Arms

  • Arm: MUSE-OVARY Cohort A
    All participants in this single-arm observational cohort are women aged 28-70 years experiencing perimenopause who elect to receive ultrasound-guided intra-ovarian injection of Muse cells (Multilineage-differentiating Stress-Enduring cells) as part of their standard clinical regenerative medicine care. No participants are assigned to any intervention by the study protocol; treatment decisions are made between the participant and their physician. Muse cells are prepared under GMP conditions. Cells are administered via transvaginal ultrasound guided bilateral ovarian stromal injection (or laparoscopic approach if clinically indicated), with an optional concurrent intravenous infusion for systemic support. Participants are followed prospectively with standardized assessments of safety, hormonal parameters, ovarian morphology via ultrasound, menstrual patterns, live births and quality of life measures for 24 months, with extended safety monitoring up to 5 years.

Primary Outcome Measure

Incidence of Adverse Events and Serious Adverse Events [ Time Frame: From baseline through 36 months post procedure, with focused monitoring in the first 30 days. ]

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