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

Early Phase 1

• Conditions: Cell- and Tissue-Based Therapy
• Interventions: Biological: Amnion only; Biological: Amnion - endometrium cells; Biological: Amnion - amnion epithelial cells; Biological: Amnion-EnSC-AESC

• Registration Number: NCT04676269
• Lead Sponsor: Indonesia University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-09
• Status Verified: 2020-12
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-15
• Last Update Submitted: 2020-12-15
• Study First Posted: 2020-12-21
• Last Update Posted: 2020-12-21
• Primary Completion: 2021-07-15
• Study Completion: 2021-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amnion only	Amnion only	Amnion bilayer as a scaffold to overlay the endometrium, with minor curettage prior to stick the scaffold.
Amnion- self endometrium stem cells (EnSC)	Amnion - endometrium cells	Amnion bilayer as a scaffold, seeded with endometrium stem cells to regenerate the thin endometrium.
Amnion- amnion epithelial stem cells (AESC)	Amnion - amnion epithelial cells	Amnion bilayer as a scaffold, seeded with amnion epithelial stem cells to regenerate the thin endometrium.
Amnion- co culture self EnSC - AESC	Amnion-EnSC-AESC	Amnion bilayer as a scaffold, seeded with co-culture of endometrium stem cells and amnion epithelial stem cells to regenerate the thin endometrium.

Primary Outcome Measures

Name	Time	Method
Change in amenorrhea severity	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	7 and 14 days after amnion bilayer seeded with endometrial cells co-cultured with hAESC is transplanted into patient' womb	Observation by USG

Trial Locations

Locations (1)

RSUPN Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia