Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04676269
Status:
UNKNOWN
Last Update Posted:
2020-12-21
First Post:
2020-12-02
Brief Title:
Amnion Bilayer and Stem Cell Combination Therapy on Thin Endometrium Infertile Patients
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
Amnion Bilayer and Stem Cell Combination Therapy on Thin Endometrium Infertile Patients
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 34 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 qPCRThe SPP1 target of MIR424 expressed during the receptive phase
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None