NCT07511660Enrolling by invitation
Intra Ovarian Muse Cell Injection for Perimenopause Symptom Relief and Ovarian Function Restoration (MUSE-OVARY)
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 12 (estimated)
- First submitted
- 28 Mar 2026
- Start date
- Jun 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- Healing Hope International
- NCT number
- NCT07511660
What you commit to
- Study type: Observational
- Planned participants: 12
- From Jun 2026 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent hormone therapy (within 3 months).
Other illness
- Uncontrolled comorbidities (e.g., severe cardiovascular disease, coagulopathy, uncontrolled diabetes or thyroid disease).
Age
- History of ovarian/gynecologic malignancy (active or \<5 years remission). Active autoimmune disease requiring immunosuppression.
Other
- Current pregnancy or lactation.
- BMI \>40 kg/m² or other factors increasing procedural risk.
- Inability to comply with study procedures.
Who the study is looking for
- 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.
Age in the registry: 28 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stem Solutions Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.