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出境医 / 临床实验 / Clinical Study of NK Cells in the Treatment of Severe Endometriosis

Clinical Study of NK Cells in the Treatment of Severe Endometriosis

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
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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
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
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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

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
Tracking Information
First Submitted Date  ICMJE March 28, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date May 14, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2019)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2019)
  • 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.
  • 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.
  • The percent of pregnancy [ Time Frame: 36 months ]
    The pregnancy will be meaured by B ultrasound.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of NK Cells in the Treatment of Severe Endometriosis
Official Title  ICMJE Clinical Study on the Treatment of Endometriosis by Combining With the Pathogenesis of Endometriosis and the Application Characteristics of NK Cells
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • NK Cell Mediated Immunity
  • Endometriosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Conventional treatment group
    GnRHa combained with reverse addition therapy
    Intervention: Drug: GnRHa combained with reverse addition therapy
  • Experimental: Conventional treatment and Autologous NK cells therapy
    GnRHa combained with reverse addition therapy and NK cell combined treatment group
    Interventions:
    • Biological: Autologous NK cell therapy
    • Drug: GnRHa combained with reverse addition therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lili Ren, Ph.D +86-755-22942466 ren.lili@szhospital.com
Contact: Min Zhang, Ph.D +86-755-22942466 zzuzhangmin@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948828
Other Study ID Numbers  ICMJE ShenzhenPH BTR-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shenzhen People's Hospital
Study Sponsor  ICMJE Shenzhen People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hui Qi, M.D Shen Zhen People's Hospital
PRS Account Shenzhen People's Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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