Clinical Study of NK Cells in the Treatment of Severe Endometriosis
Clinical Study on the Treatment of Endometriosis by Combining With the Pathogenesis of Endometriosis and the Application Characteristics of NK Cells
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2019
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2019
CompletedFirst Posted
Study publicly available on registry
May 14, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMay 14, 2019
May 1, 2019
3 years
March 28, 2019
May 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
3 months after treatment
Purity and Function of NK cells
The purity and function of NK cells will be measured by flow cytometry.
once per three months
Secondary Outcomes (3)
Endocrine hormone levels
every three months, up to 36 months
Pain score
every three months, up to 36 months
The percent of pregnancy
36 months
Study Arms (2)
Conventional treatment group
OTHERGnRHa combained with reverse addition therapy
Conventional treatment and Autologous NK cells therapy
EXPERIMENTALGnRHa combained with reverse addition therapy and NK cell combined treatment group
Interventions
After conventional treatment, the patients were treated with autologous NK cells.
Postoperative patients were treated with GnRHa combined with reverse addition treatment.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hui Qi, M.D
Shen Zhen People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2019
First Posted
May 14, 2019
Study Start
June 1, 2019
Primary Completion
May 31, 2022
Study Completion
December 31, 2022
Last Updated
May 14, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share