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Clinical Study of NK Cells in the Treatment of Severe Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948828
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Shenzhen People's Hospital

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948828


Contacts
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Contact: Lili Ren, Ph.D +86-755-22942466 ren.lili@szhospital.com
Contact: Min Zhang, Ph.D +86-755-22942466 zzuzhangmin@163.com

Locations
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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
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Study Director: Hui Qi, M.D Shen Zhen People's Hospital
More Information
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Responsible Party: Shenzhen People's Hospital
ClinicalTrials.gov Identifier: NCT03948828    
Other Study ID Numbers: ShenzhenPH BTR-003
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Endometriosis
Genital Diseases, Female