Clinical Study of NK Cells in the Treatment of Severe Endometriosis

• ClinicalTrials.gov Identifier: NCT03948828
• Recruitment Status: Not yet recruiting
• First Posted: May 14, 2019
• Last Update Posted: May 14, 2019
• Sponsor: Shenzhen People's Hospital
• Information provided by (Responsible Party): Shenzhen People's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
NK Cell Mediated Immunity; Endometriosis	Biological: Autologous NK cell therapy; Drug: GnRHa combained with reverse addition therapy	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Study on the Treatment of Endometriosis by Combining With the Pathogenesis of Endometriosis and the Application Characteristics of NK Cells
• Estimated Study Start Date: June 1, 2019
• Estimated Primary Completion Date: May 31, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Conventional treatment group; GnRHa combained with reverse addition therapy	Drug: GnRHa combained with reverse addition therapy; Postoperative patients were treated with GnRHa combined with reverse addition treatment.; Other Name: Conventional treatment
Experimental: Conventional treatment and Autologous NK cells therapy; GnRHa combained with reverse addition therapy and NK cell combined treatment group	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.; Other Name: Conventional treatment

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Endocrine hormone levels [ Time Frame: 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.
2. Pain score [ Time Frame: 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.
3. The percent of pregnancy [ Time Frame: 36 months ]
   The pregnancy will be meaured by B ultrasound.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Lili Ren, Ph.D; +86-755-22942466; ren.lili@szhospital.com

Contact: Min Zhang, Ph.D; +86-755-22942466; zzuzhangmin@163.com

Locations

China, Guangdong

Shenzhen People's Hospital

Shenzhen, Guangdong, China, 518020

Contact: Lili Ren, Ph.D +86-755-22942466 ren.lili@szhospital.com

Contact: Min Zhang, Ph.D +86-755-22942466 zzuzhangmin@163.com

Sponsors and Collaborators

Shenzhen People's Hospital

Investigators

• Study Director: Hui Qi, M.D; Shen Zhen People's Hospital

More Information

• Responsible Party: Shenzhen People's Hospital
• ClinicalTrials.gov Identifier: NCT03948828
• Other Study ID Numbers: ShenzhenPH BTR-003
• First Posted: May 14, 2019
• Last Update Posted: May 14, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shenzhen People's Hospital:

Endometriosis; NK cell therapy

Additional relevant MeSH terms:

Endometriosis