drugset / Trial / NCT04676269

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

NCT04676269 ↗

Phase 0 Unknown 40 enrolled Indonesia University
RandomizedParallel-groupQuadruple-blindOther

Summary

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.

Timeline

Start
2019-12-09
Primary completion
2021-07-15
Completion
2021-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Amnion - amnion epithelial cells Cell therapy — —
Subject Amnion - endometrium cells Cell therapy — —
Subject Amnion-EnSC-AESC Cell therapy — —

Indications

No indication recorded.