Back to results

Clinical Study of NK Cells in the Treatment of Severe Endometriosis

Primary Purpose

NK Cell Mediated Immunity, Endometriosis

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Autologous NK cell therapy

GnRHa combained with reverse addition therapy

About this trial

This is an interventional treatment trial for NK Cell Mediated Immunity focused on measuring Endometriosis, NK cell therapy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Shenzhen People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Conventional treatment group

Conventional treatment and Autologous NK cells therapy

Arm Description

GnRHa combained with reverse addition therapy

GnRHa combained with reverse addition therapy and NK cell combined treatment group

Outcomes

Primary Outcome Measures

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

Purity and Function of NK cells

The purity and function of NK cells will be measured by flow cytometry.

Secondary Outcome Measures

Endocrine hormone levels

The levels of endocrine hormone, including serum estradiol, testosterone, progesterone, luteinizing hormone and follicle stimulating hormone will be measured.

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.

The percent of pregnancy

The pregnancy will be meaured by B ultrasound.

Full Information

NCT ID

NCT03948828

First Posted

March 28, 2019

Last Updated

May 12, 2019

Sponsor

Shenzhen People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03948828

Brief Title

Clinical Study of NK Cells in the Treatment of Severe Endometriosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2019 (Anticipated)

Primary Completion Date

May 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NK Cell Mediated Immunity, Endometriosis

Keywords

Endometriosis, NK cell therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conventional treatment group

Arm Type

Other

Arm Description

GnRHa combained with reverse addition therapy

Arm Title

Conventional treatment and Autologous NK cells therapy

Arm Type

Experimental

Arm Description

GnRHa combained with reverse addition therapy and NK cell combined treatment group

Intervention Type

Biological

Intervention Name(s)

Autologous NK cell therapy

Intervention Description

After conventional treatment, the patients were treated with autologous NK cells.

Intervention Type

Drug

Intervention Name(s)

GnRHa combained with reverse addition therapy

Other Intervention Name(s)

Conventional treatment

Intervention Description

Postoperative patients were treated with GnRHa combined with reverse addition treatment.

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events [Safety]

Description

Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0

Time Frame

3 months after treatment

Title

Purity and Function of NK cells

Description

The purity and function of NK cells will be measured by flow cytometry.

Time Frame

once per three months

Secondary Outcome Measure Information:

Title

Endocrine hormone levels

Description

The levels of endocrine hormone, including serum estradiol, testosterone, progesterone, luteinizing hormone and follicle stimulating hormone will be measured.

Time Frame

every three months, up to 36 months

Title

Pain score

Description

Time Frame

every three months, up to 36 months

Title

The percent of pregnancy

Description

The pregnancy will be meaured by B ultrasound.

Time Frame

36 months

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lili Ren, Ph.D

Phone

+86-755-22942466

ren.lili@szhospital.com

First Name & Middle Initial & Last Name or Official Title & Degree

Min Zhang, Ph.D

Phone

+86-755-22942466

zzuzhangmin@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hui Qi, M.D

Organizational Affiliation

Shen Zhen People's Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Shenzhen People's Hospital

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518020

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lili Ren, Ph.D

Phone

+86-755-22942466

ren.lili@szhospital.com

First Name & Middle Initial & Last Name & Degree

Min Zhang, Ph.D

Phone

+86-755-22942466

zzuzhangmin@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Study of NK Cells in the Treatment of Severe Endometriosis

We'll reach out to this number within 24 hrs