Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (22)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cell Therapy | — | UNRESOLVED | — |
| Diminished Ovarian Reserve | — | UNRESOLVED | — |
| Diminished Ovarian Reserve (DOR) | — | UNRESOLVED | — |
| Diminished Ovarian Reserve Due to Advanced Maternal Age | — | UNRESOLVED | — |
| Hormonal Imbalance | — | UNRESOLVED | — |
| Hormone Disturbance | — | UNRESOLVED | — |
| Menopause | — | UNRESOLVED | — |
| Menopause Hot Flashes | — | UNRESOLVED | — |
| Menopause Ovarian Failure | — | UNRESOLVED |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- MUSE-OVARY Cohort A
- description
- 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 outcomes (1)
- measure
- Incidence of Adverse Events and Serious Adverse Events
- timeFrame
- From baseline through 36 months post procedure, with focused monitoring in the first 30 days.
- description
- 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.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 28 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDKim HK, Kim TJ. Current Status and Future Prospects of Stem Cell Therapy for Infertile Patients with Premature Ovarian Insufficiency. Biomolecules. 2024 Feb 19;14(2):242. doi: 10.3390/biom14020242. PMID 38397479
- BACKGROUNDAlanazi RF, Alhwity BS, Almahlawi RM, Alatawi BD, Albalawi SA, Albalawi RA, Albalawi AA, Abdel-Maksoud MS, Elsherbiny N. Multilineage Differentiating Stress Enduring (Muse) Cells: A New Era of Stem Cell-Based Therapy. Cells. 2023 Jun 21;12(13):1676. doi: 10.3390/cells12131676. PMID 37443710
- BACKGROUNDDezawa M. Muse Cells Provide the Pluripotency of Mesenchymal Stem Cells: Direct Contribution of Muse Cells to Tissue Regeneration. Cell Transplant. 2016;25(5):849-61. doi: 10.3727/096368916X690881. Epub 2016 Feb 15. PMID 26884346
- BACKGROUNDDezawa M. The Muse Cell Discovery, Thanks to Wine and Science. Adv Exp Med Biol. 2018;1103:1-11. doi: 10.1007/978-4-431-56847-6_1. PMID 30484221
- BACKGROUNDWakao S, Akashi H, Kushida Y, Dezawa M. Muse cells, newly found non-tumorigenic pluripotent stem cells, reside in human mesenchymal tissues. Pathol Int. 2014 Jan;64(1):1-9. doi: 10.1111/pin.12129. PMID 24471964
- BACKGROUNDOgura F, Wakao S, Kuroda Y, Tsuchiyama K, Bagheri M, Heneidi S, Chazenbalk G, Aiba S, Dezawa M. Human adipose tissue possesses a unique population of pluripotent stem cells with nontumorigenic and low telomerase activities: potential implications in regenerative medicine. Stem Cells Dev. 2014 Apr 1;23(7):717-28. doi: 10.1089/scd.2013.0473. Epub 2014 Jan 17. PMID 24256547
- BACKGROUNDTatsumi K, Kushida Y, Wakao S, Kuroda Y, Dezawa M. Protocols for Isolation and Evaluation of Muse Cells. Adv Exp Med Biol. 2018;1103:69-101. doi: 10.1007/978-4-431-56847-6_4. PMID 30484224