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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04676269
• Other study ID #: 19-10-1202
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 9, 2019
• Est. completion date: December 15, 2021

Study information

• Verified date: December 2020
• Source: Indonesia University
• Contact: Achmad Kemal Harzif, MD
• Phone: +62 813-1586-6390
• Email: kemal.achmad[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cell- and Tissue-Based Therapy
• Infertility

Intervention

Biological:
• Amnion only
Patients endometrium will be transplanted with amnion only (without seeded cells)
• Amnion - endometrium cells
Patients endometrium will be transplanted with amnion seeded with endometrium cells isolated from the patients themselves
• Amnion - amnion epithelial cells
Patients endometrium will be transplanted with amnion seeded with amnion epithelial stem cells isolated from other patients' caesarean sectio amnion membrane (tested HLA-DR negative to prevent rejection)
• Amnion-EnSC-AESC
Patients endometrium will be transplanted with amnion seeded with endometrium cells-amnion epithelial stem cells co-culture

Locations

Country	Name	City	State
Indonesia	RSUPN Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in endometrium thickness	Observation by USG	7 and 14 days after amnion bilayer seeded with endometrial cells co-cultured with hAESC is transplanted into patient' womb
Primary	Change in amenorrhea severity	Patients' report	7 and 14 days after amnion bilayer seeded with endometrial cells co-cultured with hAESC is transplanted into patient' womb