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临床试验/NCT04676269
NCT04676269Unknown1 期

Amnion Bilayer and Stem Cell Combination Therapy on Thin Endometrium Infertile Patients

Indonesia University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年12月9日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
40
试验地点
1
主要终点
Change in amenorrhea severity

研究概览

简要总结

Severe infections or trauma to the endometrial lining causes permanent scars that disrupt the menstrual cycle and lead to conceive failure. Transplantation of biological graft seeded with stem cells is purposed to regenerate and recover the capability of the endometrial lining back into its cycles. Initially, the techniques to isolate and culture the endometrial cells and amnion epithelial stem cells were developed, then the endometrial cells form patients with thin endometrium. Tissue were obtained from hysteroscopic biopsy, weight between 100 µl, while up to 20 µl from the thin endometrium. Tissue were digested using collagenase-1 and cultured using DMEM-F12 added wit epidermal growth factor. Endometrial cells will be characterized to SSUD2, ICAM and BRCP1. Amnion epithelial stem cells (hAESC) will be isolated using collagenase-1 and hyaluronidase. Characterization towards TRA-1-60, SSEA-4, Oct 3/4, and Nanog. In the future, the cells will be co-culture on amnion bilayer, and stained using IHC against α-cadherin, estrogen receptor α, progesterone receptor. Endometrial receptivity (HOXA10, LIF (early secretory) adhesion, VEGF, osteopontin (SPP1) to indicate the pinopodes will be identified using qPCR.The SPP1, target of MIR424 expressed during the receptive phase.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

None of the participants, gynecologists, statistician, nurses nor of the participant' partners are informed about the treatment groups.

入排标准

年龄范围
— 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Patients with thin endometrium without scar
  • •Patients with acute thin endometrium post-therapy (medicamentosa)
  • •Patients who are willing to participate in the study

排除标准

  • •Patients with thin endometrium due to TB
  • •Patients with cancer in the reproductive system

研究组 & 干预措施

Amnion only

Sham Comparator

Amnion bilayer as a scaffold to overlay the endometrium, with minor curettage prior to stick the scaffold.

干预措施: Amnion only (Biological)

Amnion- self endometrium stem cells (EnSC)

Experimental

Amnion bilayer as a scaffold, seeded with endometrium stem cells to regenerate the thin endometrium.

干预措施: Amnion - endometrium cells (Biological)

Amnion- amnion epithelial stem cells (AESC)

Experimental

Amnion bilayer as a scaffold, seeded with amnion epithelial stem cells to regenerate the thin endometrium.

干预措施: Amnion - amnion epithelial cells (Biological)

Amnion- co culture self EnSC - AESC

Experimental

Amnion bilayer as a scaffold, seeded with co-culture of endometrium stem cells and amnion epithelial stem cells to regenerate the thin endometrium.

干预措施: Amnion-EnSC-AESC (Biological)

结局指标

主要结局

Change in amenorrhea severity

时间窗: 7 and 14 days after amnion bilayer seeded with endometrial cells co-cultured with hAESC is transplanted into patient' womb

Patients' report

Change in endometrium thickness

时间窗: 7 and 14 days after amnion bilayer seeded with endometrial cells co-cultured with hAESC is transplanted into patient' womb

Observation by USG

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. Achmad Kemal Harzif, SpOG (K)

Principal Investigator

Indonesia University

研究点 (1)

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