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NCT07511660

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

Sponsor: Healing Hope International

View on ClinicalTrials.gov

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.

Official title: Prospective Single Arm Observational Cohort Study of Ultrasound Guided Intra Ovarian Injection of Muse Cells (Multilineage Differentiating Stress-Enduring Cells) for Reversal of Perimenopausal Ovarian Decline in Women Aged 28-70 Years

Key Details

Gender

FEMALE

Age Range

28 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

12

Start Date

2026-06-01

Completion Date

2030-07-30

Last Updated

2026-04-06

Healthy Volunteers

No

Locations (1)

Stem Solutions

Monterrey, Nuevo León, Mexico