Clinical Study of NK Cells in the Treatment of Severe Endometriosis

Southern University of Science and Technology

Status and phase: Unknown; Phase 1

Conditions: NK Cell Mediated Immunity; Endometriosis

Treatments: Drug: GnRHa combained with reverse addition therapy; Biological: Autologous NK cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03948828

ShenzhenPH BTR-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Conventional treatment group

Other group

Description:

GnRHa combained with reverse addition therapy

Treatment:

Drug: GnRHa combained with reverse addition therapy

Conventional treatment and Autologous NK cells therapy

Experimental group

Description:

GnRHa combained with reverse addition therapy and NK cell combined treatment group

Treatment:

Drug: GnRHa combained with reverse addition therapy

Biological: Autologous NK cell therapy