Cell- and Tissue-Based TherapyEarly Phase 1NCT04676269
Amnion Bilayer and Stem Cell Combination Therapy on Thin Endometrium Infertile Patients
A Early Phase 1 study testing Amnion only, Amnion - endometrium cells and Amnion - amnion epithelial cells in people with Cell- and Tissue-Based Therapy, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Cell- and Tissue-Based Therapy
- What is being tested?
- Amnion only, Amnion - endometrium cells and Amnion - amnion epithelial cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 9 Dec 2019to 15 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with thin endometrium without scar
- Patients with acute thin endometrium post-therapy (medicamentosa)
- Patients who are willing to participate in the study
Who cannot join
- Patients with thin endometrium due to TB
- Patients with cancer in the reproductive system
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSUPN Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430
Achmad Kemal Harzif, MD, +6281315866390, kemal.achmad@gmail.com
Normalina Sandora, PhD, +6281298963425, normalina.sandora@gmail.com
About this study
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.
- Conditions
- Cell- and Tissue-Based Therapy
- Being tested
- Amnion only, Amnion - endometrium cells, Amnion - amnion epithelial cells, Amnion-EnSC-AESC
- Keywords
- Endometrial stem cells, Amnion epithelial stem cells, Amnion bilayer, Thin endometrium, Secondary amenorrhoe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnion onlyBiological
Patients endometrium will be transplanted with amnion only (without seeded cells)
Amnion - endometrium cellsBiological
Patients endometrium will be transplanted with amnion seeded with endometrium cells isolated from the patients themselves
Amnion - amnion epithelial cellsBiological
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-AESCBiological
Patients endometrium will be transplanted with amnion seeded with endometrium cells-amnion epithelial stem cells co-culture
| Study group | Role | What they receive |
|---|---|---|
| Amnion only | Sham comparator | Amnion bilayer as a scaffold to overlay the endometrium, with minor curettage prior to stick the scaffold. Receives: Biological: Amnion only |
| Amnion- self endometrium stem cells (EnSC) | Experimental | Amnion bilayer as a scaffold, seeded with endometrium stem cells to regenerate the thin endometrium. Receives: Biological: Amnion - endometrium cells |
| Amnion- amnion epithelial stem cells (AESC) | Experimental | Amnion bilayer as a scaffold, seeded with amnion epithelial stem cells to regenerate the thin endometrium. Receives: Biological: Amnion - amnion epithelial cells |
| Amnion- co culture self EnSC - AESC | Experimental | Amnion bilayer as a scaffold, seeded with co-culture of endometrium stem cells and amnion epithelial stem cells to regenerate the thin endometrium. Receives: Biological: Amnion-EnSC-AESC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endometrium thickness
Observation by USG
Measured: 7 and 14 days after amnion bilayer seeded with endometrial cells co-cultured with hAESC is transplanted into patient' womb
Change in amenorrhea severity
Patients' report
Measured: 7 and 14 days after amnion bilayer seeded with endometrial cells co-cultured with hAESC is transplanted into patient' womb
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start9 Dec 2019
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cell- and Tissue-Based TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Achmad Kemal Harzif, SpOG (K), Universitas Indonesia
- Investigators
- Achmad Kemal Harzif, MD, Principal investigator, Faculty of Medicine, Indonesia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676269
- Sponsor's protocol ID
- 19-10-1202
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amnion Bilayer and Stem Cell Combination Therapy on Thin Endometrium Infertile Patients
- ClinicalTrials.gov ID
- NCT04676269
- Acronym / sponsor ID
- 19-10-1202
- Conditions
- Cell- and Tissue-Based Therapy
- Keywords
- Endometrial stem cells, Amnion epithelial stem cells, Amnion bilayer, Thin endometrium, Secondary amenorrhoe
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Amnion only | Sham comparator | Biological: Amnion onlyAmnion bilayer as a scaffold to overlay the endometrium, with minor curettage prior to stick the scaffold. |
| Amnion- self endometrium stem cells (EnSC) | Experimental | Biological: Amnion - endometrium cellsAmnion bilayer as a scaffold, seeded with endometrium stem cells to regenerate the thin endometrium. |
| Amnion- amnion epithelial stem cells (AESC) | Experimental | Biological: Amnion - amnion epithelial cellsAmnion bilayer as a scaffold, seeded with amnion epithelial stem cells to regenerate the thin endometrium. |
| Amnion- co culture self EnSC - AESC | Experimental | Biological: Amnion-EnSC-AESCAmnion bilayer as a scaffold, seeded with co-culture of endometrium stem cells and amnion epithelial stem cells to regenerate the thin endometrium. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with thin endometrium without scar
- Patients with acute thin endometrium post-therapy (medicamentosa)
- Patients who are willing to participate in the study
Key exclusion criteria (2 listed)
- Patients with thin endometrium due to TB
- Patients with cancer in the reproductive system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amnion onlyPatients endometrium will be transplanted with amnion only (without seeded cells) | Biological | Amnion only |
| Amnion - endometrium cellsPatients endometrium will be transplanted with amnion seeded with endometrium cells isolated from the patients themselves | Biological | Amnion- self endometrium stem cells (EnSC) |
| Amnion - amnion epithelial cellsPatients 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) | Biological | Amnion- amnion epithelial stem cells (AESC) |
| Amnion-EnSC-AESCPatients endometrium will be transplanted with amnion seeded with endometrium cells-amnion epithelial stem cells co-culture | Biological | Amnion- co culture self EnSC - AESC |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Achmad Kemal Harzif, MD principal investigator
Faculty of Medicine, Indonesia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Amnion only, Amnion - endometrium cells and Amnion - amnion epithelial cells in people with Cell- and Tissue-Based Therapy, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Achmad Kemal Harzif, MD (+62 813-1586-6390, kemal.achmad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.