Clinical Study of NK Cells in the Treatment of Severe Endometriosis

Phase 1

• Conditions: NK Cell Mediated Immunity; Endometriosis
• Interventions: Drug: GnRHa combained with reverse addition therapy; Biological: Autologous NK cell therapy

• Registration Number: NCT03948828
• Lead Sponsor: Shenzhen People's Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-03-28
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-12
• Last Update Submitted: 2019-05-12
• Study First Posted: 2019-05-14
• Last Update Posted: 2019-05-14
• Study Start: 2019-06-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Diagonsed as endometriosis stage III~IV
2. Age ≥18 years ≤ 45 years at the time of informed consent
3. With indications for conservative endometriosis surgery
4. With complete clinical data

Exclusion Criteria

1. Severe allergy to drugs
2. Patients with abnormal immune status (Autoimmune disease or long-term use of immunosuppressive agents)
3. With serious cardiac, cerebrovascular diseases and liver, kidney disorders
4. With a history of severe mental illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional treatment group	GnRHa combained with reverse addition therapy	GnRHa combained with reverse addition therapy
Conventional treatment and Autologous NK cells therapy	Autologous NK cell therapy	GnRHa combained with reverse addition therapy and NK cell combined treatment group
Conventional treatment and Autologous NK cells therapy	GnRHa combained with reverse addition therapy	GnRHa combained with reverse addition therapy and NK cell combined treatment group

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Endocrine hormone levels	every three months, up to 36 months	The levels of endocrine hormone, including serum estradiol, testosterone, progesterone, luteinizing hormone and follicle stimulating hormone will be measured.
Pain score	every three months, up to 36 months	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.
The percent of pregnancy	36 months	The pregnancy will be meaured by B ultrasound.

Trial Locations

Locations (1)

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China