Clinical Study of Human Umbilical Artery Derived Perivascular Stem Cells in the Treatment of Premature Ovarian Failure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Antral Follicle Diameter
研究概览
简要总结
This study was a single-center randomized controlled trial at the Affiliated Drum Tower Hospital of Nanjing University Medical School. There were patients who underwent clinical follow-ups since 2018 in POF clinic. Patients were given treatment of either UCA-PSC or WJ-MSC.
详细描述
At entry, all patients had already received a standard non-physiologic hormone replacement regimen. According to blinded preferences for participation, patients were randomized into two treatment groups after an initial 2-month washout period of no therapy. One group received UCA-PSC transplantation plus horone replacement treatment (HRT) (UCA-PSC group), while the other group received WJ-MSC transplantation plus HRT (collagen/WJ-MSC group)
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
- •Clinical diagnosis of Premature Ovarian Failure
- •Patients show no response to drug treatment
- •Willing to receive follow up
- •Willing to conceive a baby
- •Age between 18 to 39
排除标准
- •Patients with chromosome abnormalities
- •Patients with congenital ovarian malformations
- •Patients with severe endometriosis
- •Patients with thyroid dysfunction
- •Patients with pregnancy contraindications
- •Patients with hormone replacement therapy contraindications
- •Past history of ovarian tumors or after radiotherapy
- •Can not take the follow-up, or want to take other treatment during the follow-up period
- •Patients with immune system diseases
研究组 & 干预措施
UCA-PSC
Subsequent to isolation and culture of UCA-PSCs, UCA-PSCs (GMP grade, from Clinical Center for Stem Cell Research of the Affiliated Drum Tower Hospital of Nanjing University Medical School, licensed by the National Institute for China Food and Drug Control) were injected into the ovaries of patients with hormone replacement treatment, which consisted of Premarin (0.625 mg/days on days 1 through 25) combined with Provera (10 mg/day for 10 days a month with monthly withdrawal bleeding).
干预措施: transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients (Procedure)
WJ-MSC
Subsequent to isolation and culture of WJ-MSCs, WJ-MSCs (GMP grade, from Clinical Center for Stem Cell Research of the Affiliated Drum Tower Hospital of Nanjing University Medical School, licensed by the National Institute for China Food and Drug Control) were injected into the ovaries of patients with hormone replacement treatment, which consisted of Premarin (0.625 mg/days on days 1 through 25) combined with Provera (10 mg/day for 10 days a month with monthly withdrawal bleeding).
干预措施: transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients (Procedure)
结局指标
主要结局
Antral Follicle Diameter
时间窗: within the first 30 weeks (plus or minus 10 weeks) after surgery
An antral follicle (or Graafian follicle) is an ovarian follicle during a certain latter stage of folliculogenesis. The antral follicle diameter in the ovaries were record using transvaginal ultrasound scan.
blood perfusion in the ovary
时间窗: within the first 30 weeks (plus or minus 10 weeks) after surgery
Systolic/Diastolic blood pressure (S/D) value was monitored in bilateral ovaries by transvaginal color Doppler ultrasound detector.
次要结局
- blood flow index in the ovaries(within the first 30 weeks (plus or minus 10 weeks) after surgery)
研究者
Li-jun Ding
principal investigator
Nanjing University