Clinical Study of NK Cells in the Treatment of Severe Endometriosis

Study Overview
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Brief Summary
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Dysfunction of natural koller cells (NK cells) is an important factor in the development of endometriosis. NK cell therapy was applied to treat severe endometriosis, which is an exploration of the pathogenesis of this refractory disease.

Detailed Description
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Endometriosis (EMs) is one of the common and frequently occurring diseases in women of childbearing age, which seriously affects the health and quality of life of the vast majority of women. The pathogenesis of endometriosis is unknown until now, and the recurrence rate of existing treatment methods is high. It is more and more necessary to introduce new therapeutic methods and strategies in view of the mechanism associated with the reduction of natural killer cell (NK) cytotoxicity. In this study, routine therapy combined with NK cell therapy was used in the treatment of severe endometriosis. The clinical data were collected to confirm the efficacy and safety of NK cell therapy. It is expected to provide a new way of thinking and method for the clinical treatment of EMs.

Official Title
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Clinical Study on the Treatment of Endometriosis by Combining With the Pathogenesis of Endometriosis and the Application Characteristics of NK Cells

Conditions
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NK Cell Mediated Immunity, Endometriosis

Intervention / Treatment
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* Biological: Autologous NK cell therapy
* Drug: GnRHa combained with reverse addition therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagonsed as endometriosis stage III IV Age ≥18 years ≤ 45 years at the time of informed consent With indications for conservative endometriosis surgery With complete clinical data Exclusion Criteria: Severe allergy to drugs Patients with abnormal immune status (Autoimmune disease or long-term use of immunosuppressive agents) With serious cardiac, cerebrovascular diseases and liver, kidney disorders With a history of severe mental illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conventional treatment group<br>GnRHa combained with reverse addition therapy | Drug: GnRHa combained with reverse addition therapy<br>* Postoperative patients were treated with GnRHa combined with reverse addition treatment.<br>* Other names: Conventional treatment;|
| Experimental: Conventional treatment and Autologous NK cells therapy<br>GnRHa combained with reverse addition therapy and NK cell combined treatment group | Biological: Autologous NK cell therapy<br>* After conventional treatment, the patients were treated with autologous NK cells.<br>Drug: GnRHa combained with reverse addition therapy<br>* Postoperative patients were treated with GnRHa combined with reverse addition treatment.<br>* Other names: Conventional treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety] | Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 | 3 months after treatment | 
| Purity and Function of NK cells | The purity and function of NK cells will be measured by flow cytometry. | once per three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endocrine hormone levels | The levels of endocrine hormone, including serum estradiol, testosterone, progesterone, luteinizing hormone and follicle stimulating hormone will be measured. | every three months, up to 36 months | 
| Pain score | A score of 0 means that you have never had this problem, and a score of 100 means that you are always troubled by this problem and feel unbearable. You can choose any number between 0 and 100 to represent your feelings. The higher the score, the worse your feelings will be. | every three months, up to 36 months | 
| The percent of pregnancy | The pregnancy will be meaured by B ultrasound. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, NK cell therapy