Trials / Recruiting
RecruitingNCT06821685
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
- Sex
- Female
- Age
- 22 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | autologous decidual-like NK cells | intrauterine infusion |
Timeline
- Start date
- 2025-02-13
- Primary completion
- 2027-07-01
- Completion
- 2027-12-01
- First posted
- 2025-02-12
- Last updated
- 2025-11-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06821685. Inclusion in this directory is not an endorsement.