Primary Ovarian InsufficiencyPhase 1MSCLCTWPOINCT03877471
Mesenchymal Stem Cells (MSCs) - Like Cell Transplantation in Women With Primary Ovarian Insufficiency
A Phase 1 study testing Cell therapy in people with Primary Ovarian Insufficiency, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Primary Ovarian Insufficiency
- What is being tested?
- Cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2019to 31 Dec 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 Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Under 40 years of age;
- Have established regular menstrual cycle, oligomenorrhea / amenorrhea ≥ 4 months;
- FSH (Follicle-Stimulating Hormone) > 25 IU/mL;
- Bilateral ovaries are visible by ultrasound;
- Have fertility requirement, husband has sperms;
- Willing to sign the Informed Consent Form.
Who cannot join
- Primary amenorrhea;
- History of serious drug allergy or allergic constitution;
- Thrombophlebitis and thromboembolia, past and present;
- Acute or chronic infection, hematologic disease, angiocardiopathy, pulmonary disease, liver disease, nephropathy, pancreas disease
- Autoimmune disease, history of severe familial genetic disease, etc.
- Anatomical abnormality of reproductive system;
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- Contraindications for pregnancy;
- Spouse azoospermia;
- HIV+, hepatitis B, C;
- Thyroid dysfunction;
- History of previous malignant or ovarian tumors, history of ovarian therapy;
- Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
- During pregnancy or lactation;
- Alcohol or other substance abuse;
- Mental disease, communicate obstruction;
- Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period;
- Attending doctor consider inappropriate to take part in.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Stem Cell (MSC)-Like Cells Transplantation in Women With Primary Ovarian Insufficiency (POI)
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of MSC-like cell therapy in women suffering from POI.
Read the detailed description
The purpose of this work is to explore the safety and preliminary efficacy of human embryonic stem cell derived MSC-like cell transplantation in women with POI. MSC-like cells were injected directly into bilateral ovaries under transvaginal ultrasound. Patients are subjected into 3 groups, with low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells injection for each ovary. The outcomes of patients were followed after the injection every 2 weeks. The investigator mainly follow the safety indexes, and the level of sex hormone and signs of follicle growth will also be monitored. The growing follicles will be stimulated by exogenous hormone, followed by oocyte retrieval and in vitro fertilization (IVF).
- Conditions
- Primary Ovarian Insufficiency
- Being tested
- Cell therapy
- Keywords
- Mesenchymal stem cell, Transplantation, Human embryonic stem cell, Premature ovarian failure
- 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.
Cell therapyGenetic
Ovary injection with MSC-like cells through transvaginal ultrasound,3 injection points for each ovary.
| Study group | Role | What they receive |
|---|---|---|
| Low dosage | Experimental | The low dosage will inject 2 million MSC-like cells (in 100ul suspension) for each ovary. Receives: Genetic: Cell therapy |
| Medium dosage | Experimental | The medium dosage will inject 5 million MSC-like cells (in 100ul suspension) for each ovary. Receives: Genetic: Cell therapy |
| High dosage | Experimental | The high dosage will inject 10 million MSC-like cells (in 100ul suspension) for each ovary. Receives: Genetic: Cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Body temperature of the participants will be measured fortnightly after injection.
Measured: 0-24 weeks
Pulse
Pulse of the participants will be measured fortnightly after injection.
Measured: 0-24 weeks
Breaths per minute
Breathing rate of the participants will be measured fortnightly after injection.
Measured: 0-24 weeks
Blood pressure
Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.
Measured: 0-24 weeks
Secondary outcomes (5)
Number of antral follicle
The number of antral follicles developing will be recorded by transvaginal ultrasound fortnightly after injection.
Measured: 0-24 weeks
Follicle-stimulating hormone (FSH) serum level
Serum FSH level will be tested fortnightly after injection.
Measured: 0-24 weeks
Estradiol (E2) serum level
Serum E2 level will be tested fortnightly after injection.
Measured: 0-24 weeks
Anti-Mullerian hormone (AMH) serum level
Serum AMH level will be tested fortnightly after injection.
Measured: 0-24 weeks
Ovarian volume
The ovarian volume will be recorded fortnightly by transvaginal ultrasound after injection.
Measured: 0-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start3 Apr 2019
- Primary completion1 Jul 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian InsufficiencyStudies 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
- Sequential
- Model description
- Patients will be subjected into 3 groups, with a low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells transplantation for each ovary. The investigator will first carry out the low dosage group, and then the medium dosage group, based on the safety evaluation of the previous group, the high dosage group will be executed in the same way.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, National Natural Science Foundation of China
- Responsible party
- Principal investigator, Hongmei Wang, Chinese Academy of Sciences
- Investigators
- Hongmei Wang, Doctor, Principal investigator, Institute of Zoology, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877471
- Sponsor's protocol ID
- IOZ ChineseAS POI-2
- Acronym
- MSCLCTWPOI
- Status last verified
- Aug 2021
- First submitted
- 11 Mar 2019
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigator have not recruited enough participant yet, till now, most of them would like to keep the individual participant data classified.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Stem Cell (MSC)-Like Cells Transplantation in Women With Primary Ovarian Insufficiency (POI)
- ClinicalTrials.gov ID
- NCT03877471
- Acronym / sponsor ID
- MSCLCTWPOI / IOZ ChineseAS POI-2
- Conditions
- Primary Ovarian Insufficiency
- Keywords
- Mesenchymal stem cell, Transplantation, Human embryonic stem cell, Premature ovarian failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, National Natural Science Foundation of China
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 15 Mar 2019 (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.
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of MSC-like cell therapy in women suffering from POI.
Detailed description
The purpose of this work is to explore the safety and preliminary efficacy of human embryonic stem cell derived MSC-like cell transplantation in women with POI. MSC-like cells were injected directly into bilateral ovaries under transvaginal ultrasound. Patients are subjected into 3 groups, with low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells injection for each ovary. The outcomes of patients were followed after the injection every 2 weeks. The investigator mainly follow the safety indexes, and the level of sex hormone and signs of follicle growth will also be monitored. The growing follicles will be stimulated by exogenous hormone, followed by oocyte retrieval and in vitro fertilization (IVF).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be subjected into 3 groups, with a low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells transplantation for each ovary. The investigator will first carry out the low dosage group, and then the medium dosage group, based on the safety evaluation of the previous group, the high dosage group will be executed in the same way.
| Arm | Type | Receives |
|---|---|---|
| Low dosage | Experimental | Genetic: Cell therapyThe low dosage will inject 2 million MSC-like cells (in 100ul suspension) for each ovary. |
| Medium dosage | Experimental | Genetic: Cell therapyThe medium dosage will inject 5 million MSC-like cells (in 100ul suspension) for each ovary. |
| High dosage | Experimental | Genetic: Cell therapyThe high dosage will inject 10 million MSC-like cells (in 100ul suspension) for each ovary. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Under 40 years of age;
- Have established regular menstrual cycle, oligomenorrhea / amenorrhea ≥ 4 months;
- FSH (Follicle-Stimulating Hormone) > 25 IU/mL;
- Bilateral ovaries are visible by ultrasound;
- Have fertility requirement, husband has sperms;
Key exclusion criteria (17 listed)
- Primary amenorrhea;
- History of serious drug allergy or allergic constitution;
- Thrombophlebitis and thromboembolia, past and present;
- Acute or chronic infection, hematologic disease, angiocardiopathy, pulmonary disease, liver disease, nephropathy, pancreas disease
- Autoimmune disease, history of severe familial genetic disease, etc.
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 |
|---|---|---|
| Cell therapyOvary injection with MSC-like cells through transvaginal ultrasound,3 injection points for each ovary. | Genetic | High dosage, Low dosage, Medium dosage |
Primary outcome
Temperature
Time frame: 0-24 weeks
Body temperature of the participants will be measured fortnightly after injection.
Pulse
Time frame: 0-24 weeks
Pulse of the participants will be measured fortnightly after injection.
Breaths per minute
Time frame: 0-24 weeks
Breathing rate of the participants will be measured fortnightly after injection.
Blood pressure
Time frame: 0-24 weeks
Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.
5 secondary outcomes
Number of antral follicle
Time frame: 0-24 weeks
Follicle-stimulating hormone (FSH) serum level
Time frame: 0-24 weeks
Estradiol (E2) serum level
Time frame: 0-24 weeks
Anti-Mullerian hormone (AMH) serum level
Time frame: 0-24 weeks
Ovarian volume
Time frame: 0-24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: No. The investigator have not recruited enough participant yet, till now, most of them would like to keep the individual participant data classified.
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Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
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Not yet recruitingPhase 1
Oral GDC-0077 in Premature Ovarian Insufficiency
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Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
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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.
Hongmei Wang, Doctor principal investigator
Institute of Zoology, Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cell therapy in people with Primary Ovarian Insufficiency, run by Chinese Academy of Sciences at 1 site in China.
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 17 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 5 Aug 2021. 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 China. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature (time frame: 0-24 weeks). The study lists 4 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 5 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.