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| Name | Class |
|---|---|
| The University of Science and Technology of China | OTHER |
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The aim of this study is preliminary exploration of the effectiveness and duration of autologous decidual-like NK cells therapy in improving uterine NK cells dysfunction.
Menstrual blood analysis will be performed on patients with infertility or a history of adverse pregnancy outcomes who have fertility needs. Those with abnormal uterine NK cells function will be screened and given informed consent forms pre-treatment. Collecting peripheral blood from the patients, isolating and inducing in vitro culture to obtain autologous decidual like NK cells which will be perfused into their uterine. Perform continuous menstrual blood analysis within 6 months after the first treatment to assess the improvement of uterine NK cell function. If the function of uterine NK cells improves, enter the stage of attempting pregnancy and follow up pregnancy outcomes; If the function of uterine NK cells does not improve, then autologous decidual like NK cells uterine cavity perfusion therapy will be performed again. NK cells intrauterine infusion will be treated up to 2 times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous decidual-like NK cells | Experimental | Autologous decidual like NK cells will be isolated and induced in vitro culture from the patients' peripheral blood and perfused into their uterine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous decidual-like NK cells | Biological | intrauterine infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of NK cells | Improvement rate of NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells | 6 months after the first intrauterine infusion therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of improvement in NK cells | Duration of improvement in NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells | 6 months after the first intrauterine infusion therapy |
| Clinical pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yali Hu | Contact | 86-025-83106666 | 11201 | glyyhuyali@163.com |
| Hui Zhu | Contact | 86-025-83106666 | 54330 | zhuhui1231@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yali Hu | The Affiliated Drum Tower Hospital of Nanjing University | Principal Investigator |
| Hui Zhu | The Affiliated Drum Tower Hospital of Nanjing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Drum Tower Hospital of Nanjing University | Recruiting | Nanjing | Jiangsu | 210006 | China |
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Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity
| 1 year after completion of NK cells therapy |
| Ongoing pregnancy | At least 12 weeks of pregnancy, ultrasound indicates that the fetus has cardiac activity and the size of the fetus matches the gestational age | 1 year after completion of NK cells therapy |
| Live birth | Delivery of any number of neonates born at 26 or more weeks' gestation with signs of life | 1 year after completion of NK cells therapy |
| preeclampsia | The occurrence of preeclampsia during successful ongoing pregnancy after cell therapy | 1 year after completion of NK cells therapy |
| fetal growth restriction | The occurrence of fetal growth restriction during successful ongoing pregnancy after cell therapy | 1 year after completion of NK cells therapy |
| ID | Term |
|---|---|
| D000026 | Abortion, Habitual |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
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