Clinical Study of NK Cells in the Treatment of Severe Endometriosis

NCT ID: NCT03948828

Last Updated: 2019-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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NK Cell Mediated Immunity Endometriosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional treatment group

GnRHa combained with reverse addition therapy

Group Type OTHER

GnRHa combained with reverse addition therapy

Intervention Type DRUG

Postoperative patients were treated with GnRHa combined with reverse addition treatment.

Conventional treatment and Autologous NK cells therapy

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

Group Type EXPERIMENTAL

Autologous NK cell therapy

Intervention Type BIOLOGICAL

After conventional treatment, the patients were treated with autologous NK cells.

GnRHa combained with reverse addition therapy

Intervention Type DRUG

Postoperative patients were treated with GnRHa combined with reverse addition treatment.

Interventions

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Autologous NK cell therapy

After conventional treatment, the patients were treated with autologous NK cells.

Intervention Type BIOLOGICAL

GnRHa combained with reverse addition therapy

Postoperative patients were treated with GnRHa combined with reverse addition treatment.

Intervention Type DRUG

Other Intervention Names

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Conventional treatment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hui Qi, M.D

Role: STUDY_DIRECTOR

Shen Zhen People's Hospital

Locations

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Shenzhen People's Hospital

Shenzhen, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Lili Ren, Ph.D

Role: CONTACT

+86-755-22942466

Min Zhang, Ph.D

Role: CONTACT

+86-755-22942466

Facility Contacts

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Lili Ren, Ph.D

Role: primary

+86-755-22942466

Min Zhang, Ph.D

Role: backup

+86-755-22942466

Other Identifiers

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ShenzhenPH BTR-003

Identifier Type: -

Identifier Source: org_study_id

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