Endometriosis, NK Cell Mediated Immunity
Conditions
Keywords
Endometriosis, NK cell therapy
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.
Interventions
BIOLOGICALAutologous NK cell therapy
After conventional treatment, the patients were treated with autologous NK cells.
DRUGGnRHa combained with reverse addition therapy
Postoperative patients were treated with GnRHa combined with reverse addition treatment.
Sponsors
Shenzhen People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety] | 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 | once per three months | The purity and function of NK cells will be measured by flow cytometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endocrine hormone levels | 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 | 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 | 36 months | The pregnancy will be meaured by B ultrasound. |
Countries
China
Contacts
Primary ContactLili Ren, Ph.D
Backup ContactMin Zhang, Ph.D
Outcome results
None listed