Clinical Study of NK Cells in the Treatment of Severe Endometriosis

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03948828
• Other study ID #: ShenzhenPH BTR-003
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2019
• Source: Shenzhen People's Hospital
• Contact: Lili Ren, Ph.D
• Phone: +86-755-22942466
• Email: ren.lili[@]szhospital.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• NK Cell Mediated Immunity

Intervention

Biological:
• Autologous NK cell therapy
After conventional treatment, the patients were treated with autologous NK cells.

Drug:
• GnRHa combained with reverse addition therapy
Postoperative patients were treated with GnRHa combined with reverse addition treatment.

Locations

Country	Name	City	State
China	Shenzhen People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Purity and Function of NK cells	The purity and function of NK cells will be measured by flow cytometry.	once per three months
Secondary	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
Secondary	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
Secondary	The percent of pregnancy	The pregnancy will be meaured by B ultrasound.	36 months