PerimenopauseMUSE-OVARYNCT07511660
Intra Ovarian Muse Cell Injection for Perimenopause Symptom Relief and Ovarian Function Restoration (MUSE-OVARY)
An observational study of Perimenopause and Perimenopause-Related Depression, run by Healing Hope International at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 70 years, women only
- Conditions the study is for
- Perimenopause, Perimenopause-Related Depression, Premature Ovarian Insufficiency
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jun 2026to 30 Jul 2030
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this 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
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.
Read more
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.
Read the detailed description
Background:
Perimenopause involves progressive ovarian follicular depletion, erratic hypothalamic pituitary ovarian (HPO) axis function, oxidative stress, mitochondrial dysfunction, chronic low grade inflammation, and epigenetic changes. These processes lead to hormonal instability and associated symptoms. While hormone replacement therapy alleviates symptoms, it does not restore endogenous ovarian activity.
Muse cells (Multilineage-differentiating Stress-Enduring cells) are endogenous, non-tumorigenic, pluripotent like mesenchymal stem cells naturally residing in adult bone marrow, adipose tissue, and connective tissues. They demonstrate spontaneous tri-lineage differentiation potential, high stress tolerance, immune-privileged properties, and selective homing to damaged sites without genetic reprogramming or requirement for HLA matching/immunosuppression in many contexts.
Study Design
This prospective, single arm, single center observational cohort study evaluates real world safety, feasibility, and outcomes following ultrasound-guided intra-ovarian Muse cell injection in women aged 28-70 meeting STRAW+10 criteria for perimenopause. Participants self-select the procedure as part of clinical regenerative medicine care at the study site; no randomization or protocol-driven intervention assignment occurs.
Rationale and Mechanisms
Preclinical and analogous mesenchymal stem cell research in premature ovarian insufficiency (POI) and perimenopausal models suggests potential benefits through interconnected pathways, including paracrine/exosomal signaling (VEGF, IGF-1, FGF2, miR-21/miR-132), mitochondrial transfer via tunneling nanotubes, reduction of reactive oxygen species, anti-apoptotic effects (Bcl-2/Akt/survivin), immunomodulation (TGF-β1, IL-10, PGE2; shift toward Treg phenotype and reduced dendritic cell maturation), and epigenetic remodeling (delivery of DNMTs/HATs, reactivation of folliculogenesis-related genes such as FOXL2, GDF9, BMP15). Additional upstream effects on hypothalamic GnRH pulsatility and pituitary responsiveness may support overall HPO axis coordination.
Similar intra-ovarian autologous or allogeneic mesenchymal stem cell approaches in POI/perimenopausal cohorts have reported signals of improved hormonal parameters, antral follicle counts, menstrual regularity, and symptom relief with acceptable shortterm safety profiles.
Intervention Overview (high-level only) Clinical-grade Muse cells (autologous preferred from adipose or bone marrow; or allogeneic where authorized) are prepared under GMP conditions and administered via transvaginal ultrasound-guided bilateral ovarian stromal injection (laparoscopic alternative if indicated), with optional systemic intravenous support. Dosing follows a safety-informed range (0.5-2.0 × 10⁶ cells/kg total, divided between ovaries).
Objectives
Primary: Characterize safety (adverse events per CTCAE v5.0), procedural tolerability, and ovarian morphology changes over 24 months.
Secondary: Document longitudinal changes in hormonal profiles, ultrasound-based follicular parameters, menstrual cyclicity, and patient-reported outcomes (MENQOL).
Exploratory: Assess candidate mechanistic biomarkers (exosomal miRNAs, epigenetic clocks, cytokines, oxidative stress markers).
Follow-up
Standardized evaluations occur at baseline and at 1, 3, 6, 12, and 24 months, with extended annual safety monitoring up to 5 years via a registry. Assessments include serial hormone panels, transvaginal ultrasound, symptom diaries, quality-of-life measures, and safety surveillance. Optional biobanking supports future analyses.
This observational framework enables ethical collection of standardized real-world evidence on an emerging regenerative approach while generating hypothesis generating data to guide subsequent controlled trials. Information already captured elsewhere in the record (e.g., eligibility criteria, outcome measures, study type) is not repeated here.
- Conditions
- Perimenopause, Perimenopause-Related Depression, Premature Ovarian Insufficiency, Premature Ovarian Failure (POF), Premature Ovarian Failure, Menopause
- Keywords
- Premature Ovarian Insufficiency, Perimenopause, Premature Ovarian Failure, Menopause, menopause hot flashes, Hot Flashes, Ovarian Dysfunction, Diminished Ovarian Reserve, Hormone Disturbance, Hormonal Imbalance, Quality of Life, Women's Health, Vasomotor Symptoms, MuSE, Cell Therapy, Ovarian rejuvenation, Intra-ovarian injection, POI, Regenerative medicine, hormone restoration ovaries
- Medical subject headings
- Primary Ovarian Insufficiency, Endocrine System Diseases, Multiple Endocrine Neoplasia Type 1, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline through 36 months post procedure, with focused monitoring in the first 30 days.
Secondary outcomes (8)
Change in FSH Hormonal Profile
Longitudinal changes in serum levels of follicle stimulating hormone (FSH). Measured to evaluate potential stabilization or improvement in endocrine function.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-procedure.
Change in LH Hormonal Profile
Longitudinal changes in serum levels of luteinizing hormone (LH). Measured to evaluate potential stabilization or improvement in endocrine function.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post procedure.
Change in AMH Hormonal Profile
Longitudinal changes in serum levels of anti-Müllerian hormone (AMH). Measured to evaluate potential stabilization or improvement in endocrine function.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-procedure.
Change in Estradiol Hormonal Profile
Longitudinal changes in serum levels of estradiol (E2). Measured to evaluate potential stabilization or improvement in endocrine function.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-procedure.
Change in Progesterone Hormonal Profile
Longitudinal changes in serum levels of progesterone. Measured to evaluate potential stabilization or improvement in endocrine function.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-procedure.
Ovarian Follicular Reserve by Ultrasound
Change in antral follicle count (AFC) and ovarian volume assessed by transvaginal ultrasound, as objective markers of ovarian tissue response and follicular activity.
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months post-procedure.
Menstrual Cycle Regularity
Proportion of participants achieving improved menstrual regularity (reduction in cycle variability) or resumption of menses, documented via participant menstrual diaries.
Measured: Assessed continuously through 24 months; summarized at 6, 12, and 24 months.
Quality of Life and Symptom Improvement
Change in perimenopausal symptoms and overall quality of life measured by the Menopause Specific Quality of Life Questionnaire (MENQOL). Domains include vasomotor, psychosocial, physical, and sexual functioning. Success defined as ≥50% improvement in total score from baseline.
Measured: Baseline, 3 months, 6 months, 12 months, and 24 months post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Healing Hope International
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Jonatha Leicher, MD: Regenerative Medicine, Principal investigator, Healing Hope International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511660
- Sponsor's protocol ID
- MUSE-OVARY-001
- Acronym
- MUSE-OVARY
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) may be shared in the future following study completion, subject to appropriate de-identification, ethical approvals, and compliance with applicable regulatory and privacy standards. Data sharing will be considered to support scientific transparency and collaboration while protecting participant confidentiality and respecting international data governance requirements.
Publications
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.
PubMed 38397479Alanazi 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.
PubMed 37443710Dezawa 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.
PubMed 26884346Dezawa 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.
PubMed 30484221Wakao 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.
PubMed 24471964Ogura 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.
PubMed 24256547Tatsumi 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.
PubMed 30484224Dezawa M. Clinical Trials of Muse Cells. Adv Exp Med Biol. 2018;1103:305-307. doi: 10.1007/978-4-431-56847-6_17.
PubMed 30484237
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07511660
- Acronym / sponsor ID
- MUSE-OVARY / MUSE-OVARY-001
- Conditions
- Perimenopause, Perimenopause-Related Depression, Premature Ovarian Insufficiency, Premature Ovarian Failure (POF), Premature Ovarian Failure, Menopause
- Keywords
- Premature Ovarian Insufficiency, Perimenopause, Premature Ovarian Failure, Menopause, menopause hot flashes, Hot Flashes, Ovarian Dysfunction, Diminished Ovarian Reserve
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Healing Hope InternationalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Perimenopause involves progressive ovarian follicular depletion, erratic hypothalamic pituitary ovarian (HPO) axis function, oxidative stress, mitochondrial dysfunction, chronic low grade inflammation, and epigenetic changes. These processes lead to hormonal instability and associated symptoms. While hormone replacement therapy alleviates symptoms, it does not restore endogenous ovarian activity.
Muse cells (Multilineage-differentiating Stress-Enduring cells) are endogenous, non-tumorigenic, pluripotent like mesenchymal stem cells naturally residing in adult bone marrow, adipose tissue, and connective tissues. They demonstrate spontaneous tri-lineage differentiation potential, high stress tolerance, immune-privileged properties, and selective homing to damaged sites without genetic reprogramming or requirement for HLA matching/immunosuppression in many contexts.
Study Design
This prospective, single arm, single center observational cohort study evaluates real world safety, feasibility, and outcomes following ultrasound-guided intra-ovarian Muse cell injection in women aged 28-70 meeting STRAW+10 criteria for perimenopause. Participants self-select the procedure as part of clinical regenerative medicine care at the study site; no randomization or protocol-driven intervention assignment occurs.
Rationale and Mechanisms
Preclinical and analogous mesenchymal stem cell research in premature ovarian insufficiency (POI) and perimenopausal models suggests potential benefits through interconnected pathways, including paracrine/exosomal signaling (VEGF, IGF-1, FGF2, miR-21/miR-132), mitochondrial transfer via tunneling nanotubes, reduction of reactive oxygen species, anti-apoptotic effects (Bcl-2/Akt/survivin), immunomodulation (TGF-β1, IL-10, PGE2; shift toward Treg phenotype and reduced dendritic cell maturation), and epigenetic remodeling (delivery of DNMTs/HATs, reactivation of folliculogenesis-related genes such as FOXL2, GDF9, BMP15). Additional upstream effects on hypothalamic GnRH pulsatility and pituitary responsiveness may support overall HPO axis coordination.
Similar intra-ovarian autologous or allogeneic mesenchymal stem cell approaches in POI/perimenopausal cohorts have reported signals of improved hormonal parameters, antral follicle counts, menstrual regularity, and symptom relief with acceptable shortterm safety profiles.
Intervention Overview (high-level only) Clinical-grade Muse cells (autologous preferred from adipose or bone marrow; or allogeneic where authorized) are prepared under GMP conditions and administered via transvaginal ultrasound-guided bilateral ovarian stromal injection (laparoscopic alternative if indicated), with optional systemic intravenous support. Dosing follows a safety-informed range (0.5-2.0 × 10⁶ cells/kg total, divided between ovaries).
Objectives
Primary: Characterize safety (adverse events per CTCAE v5.0), procedural tolerability, and ovarian morphology changes over 24 months.
Secondary: Document longitudinal changes in hormonal profiles, ultrasound-based follicular parameters, menstrual cyclicity, and patient-reported outcomes (MENQOL).
Exploratory: Assess candidate mechanistic biomarkers (exosomal miRNAs, epigenetic clocks, cytokines, oxidative stress markers).
Follow-up
Standardized evaluations occur at baseline and at 1, 3, 6, 12, and 24 months, with extended annual safety monitoring up to 5 years via a registry. Assessments include serial hormone panels, transvaginal ultrasound, symptom diaries, quality-of-life measures, and safety surveillance. Optional biobanking supports future analyses.
This observational framework enables ethical collection of standardized real-world evidence on an emerging regenerative approach while generating hypothesis generating data to guide subsequent controlled trials. Information already captured elsewhere in the record (e.g., eligibility criteria, outcome measures, study type) is not repeated here.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 28 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
8 secondary outcomes
Change in FSH Hormonal Profile
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-procedure.
Change in LH Hormonal Profile
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post procedure.
Change in AMH Hormonal Profile
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-procedure.
Change in Estradiol Hormonal Profile
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-procedure.
Change in Progesterone Hormonal Profile
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-procedure.
Ovarian Follicular Reserve by Ultrasound
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months post-procedure.
Menstrual Cycle Regularity
Time frame: Assessed continuously through 24 months; summarized at 6, 12, and 24 months.
Quality of Life and Symptom Improvement
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months post procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 38397479Kim 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.
- Background: PubMed 37443710Alanazi 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.
- Background: PubMed 26884346Dezawa 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.
- Background: PubMed 30484221Dezawa 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.
- Background: PubMed 24471964Wakao 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.
- Background: PubMed 24256547Ogura 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.
- Background: PubMed 30484224Tatsumi 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.
- Background: PubMed 30484237Dezawa M. Clinical Trials of Muse Cells. Adv Exp Med Biol. 2018;1103:305-307. doi: 10.1007/978-4-431-56847-6_17.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) may be shared in the future following study completion, subject to appropriate de-identification, ethical approvals, and compliance with applicable regulatory and privacy standards. Data sharing will be considered to support scientific transparency and collaboration while protecting participant confidentiality and respecting international data governance requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Jonatha Leicher, MD: Regenerative Medicine principal investigator
Healing Hope International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perimenopause and Perimenopause-Related Depression, run by Healing Hope International at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07511660, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.