Loading search results
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
Sponsor study identifier
observational
12
1 country
1
Study Start
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 28, 2026
Actual (reported)April 6, 2026
Actual (reported)June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incidence of Adverse Events and Serious Adverse Events
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.
From baseline through 36 months post procedure, with focused monitoring in the first 30 days.
Change in FSH Hormonal Profile
Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-procedure.
Change in LH Hormonal Profile
Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post procedure.
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.
This is a prospective observational cohort study using convenience sampling. Participants are women aged 28-70 experiencing perimenopause who independently elect to receive ultrasound guided intra ovarian Muse cell injection as part of their routine clinical regenerative medicine care at the study center. No random sampling, probability based recruitment, or protocol-mandated intervention assignment occurs. Enrollment is open to eligible women who present seeking regenerative options for perimenopausal symptoms and ovarian support. The sampling approach reflects real world clinical practice, allowing collection of standardized longitudinal data on safety and outcomes in a self selected population. Potential selection bias toward motivated individuals interested in regenerative therapies is acknowledged and will be addressed through transparent reporting and subgroup analyses.
Stem Solutions
Monterrey, Nuevo León, 64000, Mexico
Kim 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.
Alanazi 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.
Dr. Jonatha Leicher, MD: Regenerative Medicine
Healing Hope International
First Submitted
March 28, 2026
First Posted
April 6, 2026
Study Start
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 1, 2028
Change in AMH Hormonal Profile
Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-procedure.
Change in Estradiol Hormonal Profile
Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-procedure.
Change in Progesterone Hormonal Profile
Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-procedure.
Pregnancy and Live Birth Incidence
Baseline, 1 month, 3 months, 6 months, and 12 months.
Contact the study team to confirm eligibility.
Dezawa 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.
Dezawa 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.
Wakao 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.
Ogura 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.
Tatsumi 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.
Dezawa M. Clinical Trials of Muse Cells. Adv Exp Med Biol. 2018;1103:305-307. doi: 10.1007/978-4-431-56847-6_17.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 6, 2026
Record last verified: 2026-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: