An observational study in Perimenopause, Perimenopause-Related Depression and Premature Ovarian Insufficiency, sponsored by Healing Hope International. Enrolling by invitation at 1 site in Mexico. Open to female participants aged 28 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Healing Hope International · Observational
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.
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.
181 studies on the registry are indexed under Primary Ovarian Insufficiency; 48 are open to participants now.
This study's planned enrollment of 12 is below the median of 100 across 61 observational studies indexed under Primary Ovarian Insufficiency.
Browse Primary Ovarian Insufficiency studies →Healing Hope International is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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 (active or \<5 years remission). Active disease requiring .
Uncontrolled comorbidities (e.g., severe cardiovascular disease, coagulopathy, uncontrolled diabetes or thyroid disease).
Current pregnancy or lactation.
Recent hormone therapy (within 3 months).
>40 kg/m² or other factors increasing procedural risk.
Inability to comply with study procedures.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: From baseline through 36 months post procedure, with focused monitoring in the first 30 days.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months post procedure.
Pregnancy and Live Birth Incidence
Descriptive reporting of spontaneous conceptions, IVF attempts/outcomes, clinical pregnancies, and live births during follow-up, including any associated obstetric/neonatal data where available. Not powered as a formal efficacy endpoint.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months.
Plan to share: 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.
Start is estimated for Jun 2026; primary completion for Jan 2028, 19 months later.
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