Cell- and Tissue-Based Therapy
Conditions
Keywords
Endometrial stem cells, Amnion epithelial stem cells, Amnion bilayer, Thin endometrium, Secondary amenorrhoe
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.
Interventions
BIOLOGICALAmnion only
Patients endometrium will be transplanted with amnion only (without seeded cells)
BIOLOGICALAmnion - endometrium cells
Patients endometrium will be transplanted with amnion seeded with endometrium cells isolated from the patients themselves
BIOLOGICALAmnion - 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)
BIOLOGICALAmnion-EnSC-AESC
Patients endometrium will be transplanted with amnion seeded with endometrium cells-amnion epithelial stem cells co-culture
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
None of the participants, gynecologists, statistician, nurses nor of the participant' partners are informed about the treatment groups.
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Indonesia
Contacts
Primary ContactAchmad Kemal Harzif, MD
Backup ContactNormalina Sandora, PhD
Outcome results
None listed