The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210006, China
Location status: Recruiting
Location contact
Yali Hu
CONTACT
NCT Number: NCT06821685
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.
Interested in participating?
Request Info22 year–40 year
Female
Interventional
Phase 1
Nanjing, Jiangsu, 210006, China
Location status: Recruiting
Yali Hu
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intrauterine infusion
Time frame: 6 months after the first intrauterine infusion therapy
Improvement rate of NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells
Time frame: 6 months after the first intrauterine infusion therapy
Duration of improvement in NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells
Time frame: 1 year after completion of NK cells therapy
Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity
Time frame: 1 year after completion of NK cells therapy
At least 12 weeks of pregnancy, ultrasound indicates that the fetus has cardiac activity and the size of the fetus matches the gestational age
Time frame: 1 year after completion of NK cells therapy
Delivery of any number of neonates born at 26 or more weeks' gestation with signs of life
Time frame: 1 year after completion of NK cells therapy
The occurrence of preeclampsia during successful ongoing pregnancy after cell therapy
Time frame: 1 year after completion of NK cells therapy
The occurrence of fetal growth restriction during successful ongoing pregnancy after cell therapy
Contact information is provided by the study sponsor or research team.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
Clinical Study of Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History Caused by Abnormal Uterine Natural Killer Cells
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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