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

Cell- and Tissue-Based Therapy Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cell- and Tissue-Based Therapy
• Infertility

• NCT number: NCT04676269
• Study type: Interventional
• Source: Indonesia University
• Contact: Achmad Kemal Harzif, MD
• Phone: +62 813-1586-6390
• Email: kemal.achmad@gmail.com
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 9, 2019
• Completion date: December 15, 2021