NCT07230574

Autologous Decidual-like Natural Killer Cells Therapy for Reproductive Failure

A Prospective, Multicenter, Randomized Controlled Clinical Study on Autologous Decidual-like NK Cells Therapy for Reproductive Failure Associated With Abnormal Uterine Natural Killer Cells

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: Female
• Age: 22 Years – 38 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to verify the efficacy of in vitro induction of autologous decidual-like NK cells therapy for reproductive failure associated with uterine NK cells abnormalities.

Detailed description

Participants with reproductive failure and reproductive intentions will be recruited and screened. After obtaining their informed consent, menstrual blood analysis will be performed. Participants with menstrual blood NK cell abnormalities will be randomly assigned to either the NK cell perfusion group or control group in a ratio of 2:1. After completing two rounds of NK cell therapy, the NK cell perfusion group will enter the follow-up period, while the control group will not receive interventions after randomization and enter the follow-up period directly. The following information will be recorded for all participants who undergo menstrual blood NK cell analysis, including menstrual blood analysis results, attempts to conceive, and pregnancy outcomes during the follow-up period.

Conditions

• Abortion, Missed
• Infertility Unexplained
• Reproductive Disorder

Interventions

Type	Name	Description
BIOLOGICAL	NK cell perfusion group	Completing two rounds of NK cell therapy

Timeline

• Start date: 2025-11-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-11-17
• Last updated: 2025-11-17