Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History

Clinical Study of Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History Caused by Abnormal Uterine Natural Killer Cells

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.

Study Overview

• Status: Recruiting
• Conditions: Pre-Eclampsia; Abortion, Habitual; Embryo Implantation; Infertility Unexplained
• Intervention / Treatment: Biological: autologous decidual-like NK cells

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yali Hu; Phone Number: 11201 86-025-83106666; Email: glyyhuyali@163.com
• Study Contact Backup: Name: Hui Zhu; Phone Number: 54330 86-025-83106666; Email: zhuhui1231@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • The Affiliated Drum Tower Hospital of Nanjing University
      • Contact: Yali Hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• abnormal uterine NK cell function;
• have one of the following medical history: unexplained recurrent spontaneous abortions (≥2 spontaneous abortions, including biochemical pregnancy), repeated implantation failure (failure of implantation of good-quality embryos in at least two IVF cycles), unexplained infertility, early-onset severe gestational hypertension or early-onset fetal growth restriction;
• have clear fertility desires;
• normal ovarian function or with frozen embryos;
• edometrium thickness measured by vaginal ultrasound before ovulation or at mid-luteal phase >= 7mm;
• 18kg/m^2 < Body mass index < 30kg/m^2;

Exclusion Criteria:

• using progesterone receptor modulator;
• chromosomal karyotype abnormalities in one spouse;
• severe endometriosis, uterine fibroids affecting the shape of the uterine cavity or the size of the whole uterus more than 2 and a half months of pregnancy, uterine malformation, uterine adhesion or thin endometrium;
• uncontrolled autoimmune diseases;
• abnormal blood coagulation function, abnormal liver and kidney function, or other uncontrolled basic diseases (hypertension, diabetes, thyroid disease, etc.) that the researcher access which may affect the progress of the study;
• history of pelvic malignant tumors;
• currently participating in other clinical studies;
• allergic to blood products.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: autologous decidual-like NK cells; Autologous decidual like NK cells will be isolated and induced in vitro culture from the patients' peripheral blood and perfused into their uterine.	Biological: autologous decidual-like NK cells; intrauterine infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Collaborators: The University of Science and Technology of China
• Investigators: Principal Investigator: Yali Hu, The Affiliated Drum Tower Hospital of Nanjing University; Principal Investigator: Hui Zhu, The Affiliated Drum Tower Hospital of Nanjing University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: recurrent pregnancy loss; repeated implantation failure; unexplained infertility; decidual natural killer cells
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Abortion, Spontaneous; Pre-Eclampsia; Abortion, Habitual
• Other Study ID Numbers: 2024-LCYJ-PY-50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No