Intrauterine AdhesionPhase 1NCT04232592
Clinical Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Cells in the Treatment of Moderate and Severe Intrauterine Adhesions
A Phase 1 study testing Inject a solution of stem cell preparation and Inject stem cells in people with Intrauterine Adhesion, run by Qi Zhou.
Trial summary
To observe the clinical safety of intrauterine injection of human embryonic stem cell derived mesenchymal cells in the treatment of moderate and severe intrauterine adhesion, and to preliminarily explore its clinical effectiveness in promoting endometrial regeneration and repair. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- Inject a solution of stem cell preparation and Inject stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jan 2022
- 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 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 ≤ age ≤38, female;
- According to the 1988 American Fertility Society (AFS) diagnostic criteria, patients with uterine adhesions diagnosed with full civil capacity and with a score of ≥5 were enrolled in the study;
- The patient had one or more of the following clinical symptoms: reduced menstruation or amenorrhea, periodic abdominal pain, secondary infertility, recurrent abortion, premature delivery and other adverse pregnancy outcomes;
- The uterus was smaller than 8 weeks gestation and the uterine cavity depth was less than 12 cm;
- The second to fifth day of menstruation FSH <10mIU/mL, AMH >1.2ng/mL, AFC>6;
- Understand and sign informed consent voluntarily.
Who cannot join
- Patients with acute pelvic inflammation or endometriosis;
- Having or having a history of malignancy;
- Thrombus, lupus erythematosus and other hormone use contraindications; Allergic to albumin products;
- Patients with uterine malformation, adenomyosis, submucosal uterine fibroids,and uterine fibroids of any site >5cm;
- Patients who were using anticoagulants or who had not recovered normal platelet function 10 days after discontinuation of antiplatelet drugs;
- Previous history of abnormal coagulation function or abnormality before cell transplantation;
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- Always has a history of abnormal bleeding (such as abnormal bleeding during tooth extraction), or their immediate family members have hemorrhagic disease,such as hemophilia, bleeding symptoms (e.g., hematemesis, black, serious or recurrent nasal bleeding, coughing up blood, obvious hematuria, gastrointestinal bleeding, or intracranial hemorrhage), or suspected of vascular malformation such as aneurysm by researchers determine influence cell implant operation;
- Alcohol or drug addiction;
- Participated in other interventional clinical trials within 90 days before the informed consent was signed or before the cell transplantation;
- Had used glucocorticoids or immunosuppressive drugs within 12 weeks before signing the informed consent;
- Had used antipsychotic drugs, such as antidepressants and anti-manic drugs, within 12 weeks before signing the informed consent;
- Severe heart failure within 24 weeks before the informed consent;
- Glomerular filtration rate (eGFR) <90ml/min;
- ALT>3 times normal upper limit;
- Concomitant with other serious systemic diseases, such as pulmonary heart disease, severe chronic obstructive pulmonary disease (COPD), etc;
- Patients with severe clinical infection should receive antibiotics within 1 week before signing the informed consent;
- Active infectious diseases, including but not limited to positive human immunodeficiency virus and syphilis antibody;
- The researchers considered poor compliance;
- Other conditions not suitable for participation in this clinical trial.
Trial locations and contacts
No sites are listed yet.
About this study
To observe the clinical safety of intrauterine injection of human embryonic stem cell derived mesenchymal cells in the treatment of moderate and severe intrauterine adhesion, and to preliminarily explore its clinical effectiveness in promoting endometrial regeneration and repair.
Read the detailed description
In this study, a single-center, controlled, open-label design was used for a dose escalation study.To observe the clinical safety of intrauterine injection of human embryonic stem cell derived mesenchymal cells in the treatment of moderate and severe intrauterine adhesion, and to preliminarily explore its clinical effectiveness in promoting endometrial regeneration and repair.
- Conditions
- Intrauterine Adhesion
- Being tested
- Inject a solution of stem cell preparation, Inject stem cells
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inject a solution of stem cell preparationBiological
The control group was injected with a solution of stem cell preparation
Inject stem cellsBiological
Three dose groups were designed: low dose group, medium dose group and high dose group.
| Study group | Role | What they receive |
|---|---|---|
| Stem cell preparation solution injection group | Experimental | The solution of stem cells preparation will be injected. Receives: Biological: Inject a solution of stem cell preparation |
| Injected stem cell group | Experimental | The stem cells will injected. Receives: Biological: Inject stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of different Adverse Events of transplantation of mesenchymal cells from human embryonic stem cells
Adverse events (AE), severe adverse events (SAE), and treatment-related adverse events (TEAE) occurred within 48 weeks after surgery.
Measured: Within 48 weeks after surgery
Secondary outcomes (8)
Normal recovery rate of endometrial thickness
Normal recovery rate of endometrial thickness at 1 and 2 months after surgery will be measured (effective rate = endometrium > 6mm after surgery/all participants ×100%).
Measured: 12 months
recurrence rate of intrauterine adhesions
Recurrence rate of intrauterine adhesions (defined as patients with recurrence of intrauterine adhesions reviewed by hysteroscopy at 1 month/total patients ×100%) will be measured.
Measured: 12 months
Intrauterine adhesions score
Intrauterine adhesions score will be measured according to the American Fertility Society in 1988 diagnostic criteria for intrauterine adhesions.The scores range from 1 to 12. Higher scores mean a worse outcome.
Measured: 12 months
The endometrial biopsies for CD31
Immunohistochemical results of CD31 during the two endometrial biopsies will be measured.
Measured: 12 months
Menstrual volume change
Menstrual volume change will be assessed according to menstrual blood loss chart.
Measured: 12 months
Clinical pregnancy rate
Clinical pregnancy rate, abortion rate, live birth rate, and sustained pregnancy rate (defined as live pregnancy over 12 weeks) will be assessed.
Measured: 12 months
The endometrial biopsies for estrogen
Estrogen receptor levels during the two endometrial biopsies will be measured.
Measured: 12 months
The endometrial biopsies for Ki67
Ki67 expression levels during the two endometrial biopsies will be measured.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine AdhesionStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qi Zhou
- Sponsor type
- Other government
- Collaborators
- Tongji Hospital
- Responsible party
- Sponsor-investigator, Qi Zhou, Chinese Academy of Sciences
- Investigators
- Qi Zhou, Doctor, Principal investigator, Institute of Zoology, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232592
- Sponsor's protocol ID
- Chinese ASZQ-005
- Status last verified
- Dec 2019
- First submitted
- 27 Dec 2019
- Last updated
- 18 Jan 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 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Cells in the Treatment of Moderate and Severe Intrauterine Adhesions
- ClinicalTrials.gov ID
- NCT04232592
- Acronym / sponsor ID
- Chinese ASZQ-005
- Conditions
- Intrauterine Adhesion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Qi ZhouOther government
- Collaborators
- Tongji Hospital
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 18 Jan 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.
To observe the clinical safety of intrauterine injection of human embryonic stem cell derived mesenchymal cells in the treatment of moderate and severe intrauterine adhesion, and to preliminarily explore its clinical effectiveness in promoting endometrial regeneration and repair.
Detailed description
In this study, a single-center, controlled, open-label design was used for a dose escalation study.To observe the clinical safety of intrauterine injection of human embryonic stem cell derived mesenchymal cells in the treatment of moderate and severe intrauterine adhesion, and to preliminarily explore its clinical effectiveness in promoting endometrial regeneration and repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stem cell preparation solution injection group | Experimental | Biological: Inject a solution of stem cell preparationThe solution of stem cells preparation will be injected. |
| Injected stem cell group | Experimental | Biological: Inject stem cellsThe stem cells will injected. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 ≤ age ≤38, female;
- According to the 1988 American Fertility Society (AFS) diagnostic criteria, patients with uterine adhesions diagnosed with full civil capacity and with a score of ≥5 were enrolled in the study;
- The patient had one or more of the following clinical symptoms: reduced menstruation or amenorrhea, periodic abdominal pain, secondary infertility, recurrent abortion, premature delivery and other adverse pregnancy outcomes;
- The uterus was smaller than 8 weeks gestation and the uterine cavity depth was less than 12 cm;
- The second to fifth day of menstruation FSH <10mIU/mL, AMH >1.2ng/mL, AFC>6;
Key exclusion criteria (19 listed)
- Patients with acute pelvic inflammation or endometriosis;
- Having or having a history of malignancy;
- Thrombus, lupus erythematosus and other hormone use contraindications; Allergic to albumin products;
- Patients with uterine malformation, adenomyosis, submucosal uterine fibroids,and uterine fibroids of any site >5cm;
- Patients who were using anticoagulants or who had not recovered normal platelet function 10 days after discontinuation of antiplatelet drugs;
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 |
|---|---|---|
| Inject a solution of stem cell preparationThe control group was injected with a solution of stem cell preparation | Biological | Stem cell preparation solution injection group |
| Inject stem cellsThree dose groups were designed: low dose group, medium dose group and high dose group. | Biological | Injected stem cell group |
Primary outcome
Incidence of different Adverse Events of transplantation of mesenchymal cells from human embryonic stem cells
Time frame: Within 48 weeks after surgery
Adverse events (AE), severe adverse events (SAE), and treatment-related adverse events (TEAE) occurred within 48 weeks after surgery.
8 secondary outcomes
Normal recovery rate of endometrial thickness
Time frame: 12 months
recurrence rate of intrauterine adhesions
Time frame: 12 months
Intrauterine adhesions score
Time frame: 12 months
The endometrial biopsies for CD31
Time frame: 12 months
Menstrual volume change
Time frame: 12 months
Clinical pregnancy rate
Time frame: 12 months
The endometrial biopsies for estrogen
Time frame: 12 months
The endometrial biopsies for Ki67
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 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.
Qi Zhou, Doctor principal investigator
Institute of Zoology, Chinese Academy of Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inject a solution of stem cell preparation and Inject stem cells in people with Intrauterine Adhesion, run by Qi Zhou.
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 19 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 18 Jan 2020. 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.
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 Liu Wang, Doctor (+86-01064807858, wangliu@ioz.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of different Adverse Events of transplantation of mesenchymal cells from human embryonic stem cells (time frame: Within 48 weeks after surgery). 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 18 Jan 2020.