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

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ClinicalTrials.gov Identifier: NCT04676269
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
dr. Achmad Kemal Harzif, SpOG (K), Indonesia University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cell- and Tissue-Based Therapy Biological: Amnion only Biological: Amnion - endometrium cells Biological: Amnion - amnion epithelial cells Biological: Amnion-EnSC-AESC Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: None of the participants, gynecologists, statistician, nurses nor of the participant' partners are informed about the treatment groups.
Primary Purpose: Other
Official Title: Amnion Bilayer and Stem Cell Combination Therapy on Thin Endometrium Infertile Patients
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Amnion only
Amnion bilayer as a scaffold to overlay the endometrium, with minor curettage prior to stick the scaffold.
 Biological: Amnion only
Patients endometrium will be transplanted with amnion only (without seeded cells)
Experimental: Amnion- self endometrium stem cells (EnSC)
Amnion bilayer as a scaffold, seeded with endometrium stem cells to regenerate the thin endometrium.
 Biological: Amnion - endometrium cells
Patients endometrium will be transplanted with amnion seeded with endometrium cells isolated from the patients themselves
Experimental: Amnion- amnion epithelial stem cells (AESC)
Amnion bilayer as a scaffold, seeded with amnion epithelial stem cells to regenerate the thin endometrium.
 Biological: 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)
Experimental: Amnion- co culture self 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.
 Biological: Amnion-EnSC-AESC
Patients endometrium will be transplanted with amnion seeded with endometrium cells-amnion epithelial stem cells co-culture


Outcome Measures
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Primary Outcome Measures :
  1. Change in endometrium thickness [ Time Frame: 7 and 14 days after amnion bilayer seeded with endometrial cells co-cultured with hAESC is transplanted into patient' womb ]
    Observation by USG

  2. Change in amenorrhea severity [ Time Frame: 7 and 14 days after amnion bilayer seeded with endometrial cells co-cultured with hAESC is transplanted into patient' womb ]
    Patients' report


Eligibility Criteria
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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676269


Contacts
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Contact: Achmad Kemal Harzif, MD +62 813-1586-6390 kemal.achmad@gmail.com
Contact: Normalina Sandora, PhD +62 812-9896-3425 normalinasandora@gmail.com

Locations
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Indonesia
RSUPN Cipto Mangunkusumo Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Achmad Kemal Harzif, MD    +6281315866390    kemal.achmad@gmail.com   
Contact: Normalina Sandora, PhD    +6281298963425    normalina.sandora@gmail.com   
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Achmad Kemal Harzif, MD Faculty of Medicine, Indonesia University
More Information
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Responsible Party: dr. Achmad Kemal Harzif, SpOG (K), Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT04676269    
Other Study ID Numbers: 19-10-1202
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by dr. Achmad Kemal Harzif, SpOG (K), Indonesia University:
Endometrial stem cells
Amnion epithelial stem cells
Amnion bilayer
Thin endometrium
Secondary amenorrhoe
Additional relevant MeSH terms:
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Infertility