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

NCT ID: NCT04676269

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-09

Study Completion Date

2021-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Cell- and Tissue-Based Therapy

Keywords

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Endometrial stem cells Amnion epithelial stem cells Amnion bilayer Thin endometrium Secondary amenorrhoe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
None of the participants, gynecologists, statistician, nurses nor of the participant' partners are informed about the treatment groups.

Study Groups

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Amnion only

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

Group Type SHAM_COMPARATOR

Amnion only

Intervention Type BIOLOGICAL

Patients endometrium will be transplanted with amnion only (without seeded cells)

Amnion- self endometrium stem cells (EnSC)

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

Group Type EXPERIMENTAL

Amnion - endometrium cells

Intervention Type BIOLOGICAL

Patients endometrium will be transplanted with amnion seeded with endometrium cells isolated from the patients themselves

Amnion- amnion epithelial stem cells (AESC)

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

Group Type EXPERIMENTAL

Amnion - amnion epithelial cells

Intervention Type BIOLOGICAL

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- 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.

Group Type EXPERIMENTAL

Amnion-EnSC-AESC

Intervention Type BIOLOGICAL

Patients endometrium will be transplanted with amnion seeded with endometrium cells-amnion epithelial stem cells co-culture

Interventions

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Amnion only

Patients endometrium will be transplanted with amnion only (without seeded cells)

Intervention Type BIOLOGICAL

Amnion - endometrium cells

Patients endometrium will be transplanted with amnion seeded with endometrium cells isolated from the patients themselves

Intervention Type 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)

Intervention Type BIOLOGICAL

Amnion-EnSC-AESC

Patients endometrium will be transplanted with amnion seeded with endometrium cells-amnion epithelial stem cells co-culture

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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dr. Achmad Kemal Harzif, SpOG (K)

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Achmad Kemal Harzif, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Indonesia University

Locations

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RSUPN Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Achmad Kemal Harzif, MD

Role: CONTACT

Phone: +62 813-1586-6390

Email: [email protected]

Normalina Sandora, PhD

Role: CONTACT

Phone: +62 812-9896-3425

Email: [email protected]

Facility Contacts

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Achmad Kemal Harzif, MD

Role: primary

Normalina Sandora, PhD

Role: backup

Other Identifiers

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19-10-1202

Identifier Type: -

Identifier Source: org_study_id