Asherman's SyndromePhase 1NCT03223454

Human Amniotic Epithelial Cells for Asherman's Syndrome

A Phase 1 study testing hAECs and biological amnion in people with Asherman's Syndrome, run by The Second Affiliated Hospital of Chongqing Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This project aims to investigate the safety and effectiveness of human amniotic epithelial cells in the treatment of the severe refractory Asherman's syndrome. Read more about this study

Who is it for?: Ages 20 to 40 years, women only
Conditions the study is for: Asherman's Syndrome
What is being tested?: hAECs and biological amnion
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: No sites listed yet
Study dates: Oct 2017to Mar 2021
Phase: 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 20 to 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

1. Hysteroscopy examination confirms intrauterine adhesions, II -III according to the American Fertility Society (AFS) classification of uterine adhesions;
2. Regular Menstrual cycles and menstruation is normal before abortion or curettage;
3. Having a clear desire to fertility;
4. Normal blood coagulation, liver, heart, and kidney function, absence of HIV, Hepatitis B or C, syphilis and psychiatric pathology;
5. Serum β-hCG is negative;
6. Be willing to complete the study and sign the consent form.

Who cannot join

1. Having a history of malignant tumor;
2. Having other uterine diseases, such as, uterine fibroids, adenomyosis and uterine malformations;
3. Hysteroscopic adhesiolysis more than 3 times in the past;
4. Absence of peripheral vein access.

Trial locations and contacts

No sites are listed yet.

Lina Hu contact

Chanyu Zhang contact

About this study

Official title: Safety and Therapeutic Effect of Human Amniotic Epithelial Cells in Severe Refractory Asherman's Syndrome

This project aims to investigate the safety and effectiveness of human amniotic epithelial cells in the treatment of the severe refractory Asherman's syndrome.

Read the detailed description

Asherman's syndrome is a gynecological disorder caused by the destruction of the endometrium due to repeated or aggressive curettages and/or endometritis. As a result, there is a loss of functional endometrium in multiple areas and the uterine cavity is obliterated by intrauterine adhesions, which results in amenorrhea, hypomenorrhea, infertility and recurrent pregnancy loss. Transcervical resection of adhesion (TCRA) is the main treatment for Asherman's syndrome, so far the effect is usually poor in moderate to severe refractory cases.

Human amniotic epithelial cells (hAECs) are derived from human amniotic epithelium. hAECs retain the characteristics approximating to embryonic stem cells. Animal experiments have shown that the endometrial thickness and fertility of mice were significantly improved after intrauterine therapy with amniotic epithelial cells. To further explore the role of hAECs in Asherman's syndrome patients, this project plans to evaluate the safety of hAECs provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd., and find an effective treatment protocol.

Conditions: Asherman's Syndrome
Being tested: hAECs, biological amnion
Medical subject headings: Gynatresia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

hAECsBiological
hAECs are provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.
biological amnionBiological
Biological amnion is purchased from JiangXi RuiJi BioTechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.

Study groups in NCT03223454
Study group	Role	What they receive
biological amnion loaded with hAECs	Experimental	Biological amnion loaded with 100 million hAECs is placed into uterine cavity immediately after TCRA. Receives: Biological: hAECs
biological amnion	Placebo comparator	Biological amnion is placed into uterine cavity immediately after TCRA. Receives: Biological: biological amnion
intravenous infusion of hAECs	Experimental	intravenous infusion of 100 million hAECs immediately after TCRA Receives: Biological: hAECs
intrauterine infusion of hAECs	Experimental	100 million hAECs is infused into uterine cavity immediately after TCRA. Receives: Biological: hAECs
hydrogel loaded with hAECs	Experimental	Hydrogel loaded with 100 million hAECs is infused into uterine cavity immediately after TCRA. Receives: Biological: hAECs

What is being measured

The primary outcome is the main question the study is designed to answer.

Menstrual blood volume
Estimate the menstrual blood volume after surgery by the number of sanitary napkins per day and number of days, which will be compared with pre-operation.
Measured: at 3 months

Secondary outcomes (3)

Endometrial thickness
Measure the endometrial thickness during periovulatory period on ultrasound by the same trained medical sonographers at 3 months after surgery, compared with pre-operation.
Measured: at 3 months
Uterine volume
Measure the uterine volume during periovulatory period on ultrasound by the same trained medical sonographers at 3 months after surgery, compared with pre-operation.
Measured: at 3 months
Ongoing pregnancy rate
A ongoing pregnancy means that at the 12th week of pregnancy, ultrasound reveals that the fetus had a heart beat and the size of the fetus is in consistent with the gestational week.
Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2017Mar 2021

First posted21 Jul 2017
Study startOct 2017 (estimated)
Primary completionSep 2019 (estimated)
Study completionMar 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Asherman's SyndromeStudies 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: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03223454
Sponsor's protocol ID: 2017-116
Status last verified: Jul 2017
First submitted: 13 Jul 2017
Last updated: 21 Jul 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096.
PubMed 18406834
Ilancheran S, Moodley Y, Manuelpillai U. Human fetal membranes: a source of stem cells for tissue regeneration and repair? Placenta. 2009 Jan;30(1):2-10. doi: 10.1016/j.placenta.2008.09.009. Epub 2008 Nov 7.
PubMed 18995896

Want to know more?

Lina Hu

86-23-63693707

cqhulina@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
CURENDO (Cord-blood Uterine Regeneration Endometrium): Platelet-rich Plasma Therapy Derived From Umbilical Cord Blood for the Treatment of Endometrial Pathologies (Asherman Syndrome / Endometrial Atrophy / Thin Endometrium)
Asherman Syndrome
RecruitingPhase 1
AD-SVF Therapy for Refractory Endometrial Infertility
Endometrium; Atrophy, Intrauterine Synechiae
RecruitingEarly Phase 1
Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
Asherman Syndrome, Atrophic Endometrium
Not yet recruitingObservational study
Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
Intrauterine Abnormalities in Infertility, Asherman Syndrome
Active, not recruitingPhase 1/2
Study on the Effective Dose and Safety of Esketamine in Hysteroscopic Surgery Under Monitored Anesthesia Care
Intrauterine Polyp, Intrauterine Synechiae

All Asherman's Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Therapeutic Effect of Human Amniotic Epithelial Cells in Severe Refractory Asherman's Syndrome
ClinicalTrials.gov ID: NCT03223454
Acronym / sponsor ID: 2017-116
Conditions: Asherman's Syndrome
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
Collaborators: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Study start: Oct 2017 (estimated)
Primary completion: Sep 2019 (estimated)
Study completion: Mar 2021 (estimated)
First posted: 21 Jul 2017 (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.

This project aims to investigate the safety and effectiveness of human amniotic epithelial cells in the treatment of the severe refractory Asherman's syndrome.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
biological amnion loaded with hAECs	Experimental	Biological: hAECsBiological amnion loaded with 100 million hAECs is placed into uterine cavity immediately after TCRA.
biological amnion	Placebo comparator	Biological: biological amnionBiological amnion is placed into uterine cavity immediately after TCRA.
intravenous infusion of hAECs	Experimental	Biological: hAECsintravenous infusion of 100 million hAECs immediately after TCRA
intrauterine infusion of hAECs	Experimental	Biological: hAECs100 million hAECs is infused into uterine cavity immediately after TCRA.
hydrogel loaded with hAECs	Experimental	Biological: hAECsHydrogel loaded with 100 million hAECs is infused into uterine cavity immediately after TCRA.

Who may qualify

Ages: 20 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

1. Hysteroscopy examination confirms intrauterine adhesions, II -III according to the American Fertility Society (AFS) classification of uterine adhesions;
2. Regular Menstrual cycles and menstruation is normal before abortion or curettage;
3. Having a clear desire to fertility;
4. Normal blood coagulation, liver, heart, and kidney function, absence of HIV, Hepatitis B or C, syphilis and psychiatric pathology;
5. Serum β-hCG is negative;

Key exclusion criteria (4 listed)

1. Having a history of malignant tumor;
2. Having other uterine diseases, such as, uterine fibroids, adenomyosis and uterine malformations;
3. Hysteroscopic adhesiolysis more than 3 times in the past;
4. Absence of peripheral vein access.

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
hAECshAECs are provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.	Biological	biological amnion loaded with hAECs, hydrogel loaded with hAECs, intrauterine infusion of hAECs, intravenous infusion of hAECs
biological amnionBiological amnion is purchased from JiangXi RuiJi BioTechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.	Biological	biological amnion

Primary outcome

Menstrual blood volume
Time frame: at 3 months
Estimate the menstrual blood volume after surgery by the number of sanitary napkins per day and number of days, which will be compared with pre-operation.

3 secondary outcomes

Endometrial thickness
Time frame: at 3 months
Uterine volume
Time frame: at 3 months
Ongoing pregnancy rate
Time frame: up to 24 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
Background: PubMed 18406834Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096.
Background: PubMed 18995896Ilancheran S, Moodley Y, Manuelpillai U. Human fetal membranes: a source of stem cells for tissue regeneration and repair? Placenta. 2009 Jan;30(1):2-10. doi: 10.1016/j.placenta.2008.09.009. Epub 2008 Nov 7.

Related trials for Asherman's Syndrome

Recruiting
CURENDO (Cord-blood Uterine Regeneration Endometrium): Platelet-rich Plasma Therapy Derived From Umbilical Cord Blood for the Treatment of Endometrial Pathologies (Asherman Syndrome / Endometrial Atrophy / Thin Endometrium)
Asherman Syndrome
RecruitingPhase 1
AD-SVF Therapy for Refractory Endometrial Infertility
Endometrium; Atrophy, Intrauterine Synechiae
RecruitingEarly Phase 1
Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
Asherman Syndrome, Atrophic Endometrium
Not yet recruitingObservational study
Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
Intrauterine Abnormalities in Infertility, Asherman Syndrome
Active, not recruitingPhase 1/2
Study on the Effective Dose and Safety of Esketamine in Hysteroscopic Surgery Under Monitored Anesthesia Care
Intrauterine Polyp, Intrauterine Synechiae

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.

Lina Hu contact

Chanyu Zhang contact

Lina Hu study chair

The Second Affiliated Hospital of Chongqing Medical University

Chanyu Zhang principal investigator

The Second Affiliated Hospital of Chongqing Medical University

Fan He principal investigator

The Second Affiliated Hospital of Chongqing Medical University

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing hAECs and biological amnion in people with Asherman's Syndrome, run by The Second Affiliated Hospital of Chongqing Medical University.

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 6 inclusion and 4 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 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Lina Hu (86-23-63693707, cqhulina@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Menstrual blood volume (time frame: at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03223454, which also lists 2 linked publications.

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 Jul 2017.