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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events and Serious Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 28 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Incidence of Adverse Events and Serious Adverse Events
时间窗: 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.
次要结局
- 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.)
- 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.)
- Ovarian Follicular Reserve by Ultrasound(Baseline, 3 months, 6 months, 12 months, and 24 months post-procedure.)
- Menstrual Cycle Regularity(Assessed continuously through 24 months; summarized at 6, 12, and 24 months.)
- Quality of Life and Symptom Improvement(Baseline, 3 months, 6 months, 12 months, and 24 months post procedure.)