Premature Ovarian FailureNCT03207412
Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency
A study testing hAECs and Minimally invasive implantation in people with Premature Ovarian Failure, run by The Second Affiliated Hospital of Chongqing Medical University.
Trial summary
This project will investigate the safety and effectiveness of human amniotic epithelial cells in primary ovarian insufficiency patients and provide a new cell therapy against infertility. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Premature Ovarian Failure
- What is being tested?
- hAECs and Minimally invasive implantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2017to 31 Dec 2019
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of POI, excluding genetic disease caused by patients; POI diagnostic criteria: Patients that <40 years of age, oligomenorrhea for 4 months,FSH> 25 IU/L.
- Have fertility requirements;
- Agree to sign the designed consent for the study.
Who cannot join
- Breast cancer, ovarian cancer and other cancer/tumor;
- Contraindications for pregnancy;
- Coagulation disorder and other abnormal physical conditions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study of Minimally Invasive Implantation of Human Amniotic Epithelial Cells in the Treatment of Premature Ovarian Insufficiency
This project will investigate the safety and effectiveness of human amniotic epithelial cells in primary ovarian insufficiency patients and provide a new cell therapy against infertility.
Read the detailed description
Premature ovarian insufficiency (POI) refers to women before the 40 years of age who suffer clinical manifestations of ovarian recession. Now, there is no exact and effective treatment to restore ovarian function. Human amniotic Epithelial cells (hAECs) are derived from human amniotic epithelium. hAECs retain the characteristics of embryonic stem cells, as well as a strong differentiation potential and plasticity. Experiments show that the fertility of mice is significantly improved after amniotic epithelial cells implantation. In order to further study the role of hAECs in POI treatment, this project will conduct minimally invasive implantation with hAECs in 20 cases of POI patients, and evaluate the changes of ovarian function and the safety of hAECs implantation. hAECs is prepared by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd.
- Conditions
- Premature Ovarian Failure
- Being tested
- hAECs, Minimally invasive implantation
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hAECsBiological
human amniotic epithelial cells
Minimally invasive implantationProcedure or surgery
Minimally invasive implantation with ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive implantation | Experimental | Patients receive minimally invasive implantation, and 200 million hAECs is implanted into bilateral ovarian tissue by Ultrasound-guided puncture. Receives: Biological: hAECs; Procedure: Minimally invasive implantation |
| Intravenous infusion | Experimental | 100 million hAECs is administered by intravenous infusion every 30 days, for 3 times. Receives: Biological: hAECs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of follicle stimulating hormone(FSH)
Serum FSH level is evaluated once a month after treatment.
Measured: 1 year
antral follicle count (AFC)
the number of primordial egg follicles within the ovary per menstrual cycle
Measured: 1 year
Secondary outcomes (5)
Menstrual situation
Changes of menstrual cycle and menstrual period before and after treatment.
Measured: 1 year
Luteinizing Hormone(LH)
serum level of LH
Measured: 1 year
estrogen 2(E2)
serum level of E2
Measured: 1 year
Anti Mullerian Hormone(AMH)
serum level of AMH
Measured: 1 year
Ovarian volume
The ovarian volume is recorded by transvaginal ultrasound scan.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start22 Dec 2017 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian FailureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Responsible party
- Sponsor
- Investigators
- Chanyu Zhang, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207412
- Sponsor's protocol ID
- POI-2017
- Status last verified
- Jun 2017
- First submitted
- 30 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Minimally Invasive Implantation of Human Amniotic Epithelial Cells in the Treatment of Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT03207412
- Acronym / sponsor ID
- POI-2017
- Conditions
- Premature Ovarian Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 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
- 22 Dec 2017 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 2 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 will investigate the safety and effectiveness of human amniotic epithelial cells in primary ovarian insufficiency patients and provide a new cell therapy against infertility.
Detailed description
Premature ovarian insufficiency (POI) refers to women before the 40 years of age who suffer clinical manifestations of ovarian recession. Now, there is no exact and effective treatment to restore ovarian function. Human amniotic Epithelial cells (hAECs) are derived from human amniotic epithelium. hAECs retain the characteristics of embryonic stem cells, as well as a strong differentiation potential and plasticity. Experiments show that the fertility of mice is significantly improved after amniotic epithelial cells implantation. In order to further study the role of hAECs in POI treatment, this project will conduct minimally invasive implantation with hAECs in 20 cases of POI patients, and evaluate the changes of ovarian function and the safety of hAECs implantation. hAECs is prepared by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive implantation | Experimental | Biological: hAECs, Procedure: Minimally invasive implantationPatients receive minimally invasive implantation, and 200 million hAECs is implanted into bilateral ovarian tissue by Ultrasound-guided puncture. |
| Intravenous infusion | Experimental | Biological: hAECs100 million hAECs is administered by intravenous infusion every 30 days, for 3 times. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of POI, excluding genetic disease caused by patients; POI diagnostic criteria: Patients that <40 years of age, oligomenorrhea for 4 months,FSH> 25 IU/L.
- Have fertility requirements;
- Agree to sign the designed consent for the study.
Key exclusion criteria (3 listed)
- Breast cancer, ovarian cancer and other cancer/tumor;
- Contraindications for pregnancy;
- Coagulation disorder and other abnormal physical conditions.
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 |
|---|---|---|
| hAECshuman amniotic epithelial cells | Biological | Intravenous infusion, Minimally invasive implantation |
| Minimally invasive implantationMinimally invasive implantation with ultrasound guidance | Procedure or surgery | Minimally invasive implantation |
Primary outcome
Changes of follicle stimulating hormone(FSH)
Time frame: 1 year
Serum FSH level is evaluated once a month after treatment.
antral follicle count (AFC)
Time frame: 1 year
the number of primordial egg follicles within the ovary per menstrual cycle
5 secondary outcomes
Menstrual situation
Time frame: 1 year
Luteinizing Hormone(LH)
Time frame: 1 year
estrogen 2(E2)
Time frame: 1 year
Anti Mullerian Hormone(AMH)
Time frame: 1 year
Ovarian volume
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Chanyu Zhang principal investigator
The Second Affiliated Hospital of Chongqing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing hAECs and Minimally invasive implantation in people with Premature Ovarian Failure, 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 3 inclusion and 3 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 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Chanyu Zhang (86-23-63693296, 1317954623@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of follicle stimulating hormone(FSH) (time frame: 1 year). 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 2 Jul 2017.