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

University of Indonesia (UI)

Status and phase: Unknown; Early Phase 1

Conditions: Cell- and Tissue-Based Therapy

Treatments: Biological: Amnion - amnion epithelial cells; Biological: Amnion-EnSC-AESC; Biological: Amnion - endometrium cells; Biological: Amnion only

Study type: Interventional

Funder types: Other

Identifiers

NCT04676269

19-10-1202

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: Under 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups

Amnion only

Sham Comparator group

Description:

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

Treatment:

Biological: Amnion only

Amnion- self endometrium stem cells (EnSC)

Experimental group

Description:

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

Treatment:

Biological: Amnion - endometrium cells

Amnion- amnion epithelial stem cells (AESC)

Experimental group

Description:

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

Treatment:

Biological: Amnion - amnion epithelial cells

Amnion- co culture self EnSC - AESC

Experimental group

Description:

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

Treatment:

Biological: Amnion-EnSC-AESC