A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Hormone Replacement Therapy in Patients With Premature Ovarian Failure
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Serum Level of follicle-stimulating hormone
研究概览
简要总结
Premature ovarian failure (POF) refers the occurrence of amenorrhoea, elevated serum gonadotrophins and hypoestrogenism levels in female before the age of 40. It has important physical and psychological consequences/impact in those patients.
Premature ovarian failure (POF) is currently managed by non-physiological sex steroid regimens which are inadequate at optimizing uterine characteristics.
Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for POF.
In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation combined with Hormone Replacement Therapy will be evaluated in patients with Premature Ovarian Failure. Participants will be followed for an expected average of 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between age 18- 39 years, Female only.
- •Diagnosed with Premature Ovarian Failure，and currently receiving Hormone Replacement Therapy;
- •Willing to sign the Informed Consent Form.
排除标准
- •Fragile X chromosome.
- •polycystic ovary syndrome.
- •Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
- •Severe pulmonary and hematological disease, malignancy or hypo-immunity.
- •Currently undertaking other treatment that may affect the safety/efficacy of stem cells.
- •Pregnancy or lactation
- •Enrollment in other trials in the last 3 months. • Other criteria the investigator consider improper for inclusion.
研究组 & 干预措施
Group1 : HRT plus hUCMSCs treatment:
Participants will be given HRT plus human cord mesenchymal stem cells transplantation with a 12 menstrual Cycle follow-up.
干预措施: human umbilical cord mesenchymal stem cells (Biological)
Group 2: HRT plus hCBMNCs and hUCMSCs therapy
Participants will be given HRT plus combination of hCBMNCs together with hUCMSCs transplantation with a 12 menstrual Cycle follow-up.
干预措施: hUCMSCs and hCBMNCs (Biological)
Group3 : HRT plus hCBMNCs treatment:
Participants will be given HRT plus human cord blood mononuclear cells transplantation with a 12 menstrual Cycle follow-up.
干预措施: human cord blood mononuclear cells (Biological)
Group 4:Hormone Replacement Therapy
Participants will be given conventional therapy only with a 12 menstrual Cycle follow-up.
干预措施: Hormone Replacement Therapy (Drug)
结局指标
主要结局
Serum Level of follicle-stimulating hormone
时间窗: 48 weeks after treatment
次要结局
- Uterine and Ovary characteristics of B ultrasound， including Uterine/Ovarian size and Blood Flow(48 weeks after treatment)
- Modified Kupperman Score(48 weeks after treatment)
- Incidence of Adverse Events and Serious Adverse Events(48 weeks after treatment)