Clinical Study of NK Cells in the Treatment of Severe Endometriosis

May 12, 2019 updated by: Shenzhen People's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Conventional treatment
Experimental: Conventional treatment and Autologous NK cells therapy
GnRHa combained with reverse addition therapy and NK cell combined treatment group
Drug: GnRHa combained with reverse addition therapy
Postoperative patients were treated with GnRHa combined with reverse addition treatment.
Other Names:
  • Conventional treatment
Biological: Autologous NK cell therapy
After conventional treatment, the patients were treated with autologous NK cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after treatment
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.
once per three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every three months, up to 36 months
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.
every three months, up to 36 months
The percent of pregnancy
Time Frame: 36 months
The pregnancy will be meaured by B ultrasound.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen People's Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

May 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 28, 2019

First Submitted That Met QC Criteria

May 12, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 12, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShenzhenPH BTR-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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