A Clinical Research on SCLife®-UT hUC-MSCs Advanced Therapy Medicinal Products (hUC-MSCs ATMPs) for Patients With Thin Endometrial Infertility
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pregnancy outcome
研究概览
简要总结
To explore the therapeutic effect and safety of human umbilical cord mesenchymal stem cells on thin endometrial infertility and to explore whether human umbilical cord mesenchymal stem cells using collagen as the carrier can promote endometrial growth, reduce the recurrence rate of intrauterine adhesion, increase the clinical pregnancy rate, improve the pregnancy outcome, and study its safety.
详细描述
This is a random, open label, and self-control experiment. 24 patients are selected and sign consent forms, then divided into two groups. Doctors collect the basic information of patient (including age, BMI, mental condition, vital sign, history of disease, pharmaco-history, and so on.), evaluate the symptom of thin endometrial infertility (menstrual conditions, uterine cavity form, pregnancies).
All patients receive laboratory and image examination as baseline. Then, cell treatment will be given based on the clinical protocol. Doctors have follow-up visit on 1, 3, 6, 12 month after treatment, and do efficacy evaluation.
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
- Double (Participant, Investigator)
盲法说明
randomize double-blind
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 to 39 years with primary or secondary infertility who have received ivf embryo transfer treatment and have been frozen at least 4 good quality embryos (good quality embryos defined as 7-9C / ⅱ 0 or 4BC or more blastocysts and ≥2 grade ⅰ embryos or 4BC or more blastocysts)
- •Once above 2 times under hysteroscopy surgery adhesions, uterine cavity form has returned to normal, with normal menstrual cycle or at least a cycle high-dose estrogen replacement therapy for more than 12 days (> 4 mg/day, maximum dose of more than 8 mg/day), after treatment the biggest endometrial thickness of 7 mm or less or upper middle period of endometrial thickness of 7 mm or less on average; Or received assisted reproductive therapy, after at least 4mg/ day of estrogen, colony stimulating factor, aspirin, sildenafil and other drugs, unknown maximum endometrial thickness ≤7mm or average endometrial thickness ≤7mm in middle and upper segment; The maximum endometrial thickness in luteal phase was less than 6mm
- •18kg/m2< body mass index (BMI) <24 kg/m2
- •Voluntarily participate and sign the informed consent
- •Negative coV-19 nucleic acid test
排除标准
- •Uncured sexually transmitted diseases
- •Participate in other clinical investigators within 3 months
- •Serum pregnancy tested positive
- •Coagulopathy or other diseases of the blood system
- •Severe heart disease, unstable angina attack, cardiac insufficiency of grade III or above, acute myocardial infarction and/or old myocardial infarction, hypertension was diagnosed according to the guidelines for prevention and treatment of hypertension in China (2010 edition)
- •Patients with active genital tuberculosis
- •Patients with immune system disorders
- •Diseases related to pregnancy outcome (any) : Untreated hydrosalpinx, untreated uterine polyp, untreated uterine infection, phase III ~ Ⅳ endometriosis and adenomyosis of the uterus, ovarian cyst > 4 cm, uterine fibroids > 2 cm in diameter, multiple muscle intramural myoma, and submucosal fibroids, cesarean section incision site benign tumor prognosis, basin celiac > 4 cm, pituitary tumors and malignant tissues and organs tumors
- •Abnormal uterine bleeding
- •Severe liver and kidney function injury, namely, blood alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were 2.5 times higher than the upper limit of normal value, and blood creatinine (Cr) and urea nitrogen (BUN) were 2 times higher than the upper limit of normal value
- •The researcher considers that she is not suitable for this study
研究组 & 干预措施
stem cell and collagen transplantation group
Human Umbilical Cord Mesenchymal Stem Cells
干预措施: human umbilical cord mesenchymal stem cell complex collagen (Biological)
control group
collagen transplantation
干预措施: human umbilical cord mesenchymal stem cell complex collagen (Biological)
control group
collagen transplantation
干预措施: intrauterine injection (Procedure)
结局指标
主要结局
Pregnancy outcome
时间窗: 12 months
Pregnancy status is tracked for pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate and live birth rate.
次要结局
未报告次要终点