Clinical Study of NK Cells in the Treatment of Severe Endometriosis
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ClinicalTrials.gov Identifier: NCT03948828 |
Recruitment Status :
Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
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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 |
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 |

Arm | Intervention/treatment |
---|---|
Conventional treatment group
GnRHa combained with reverse addition therapy
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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 |
- 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.
- 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.

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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 |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948828
Contact: Lili Ren, Ph.D | +86-755-22942466 | ren.lili@szhospital.com | |
Contact: Min Zhang, Ph.D | +86-755-22942466 | zzuzhangmin@163.com |
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 |
Study Director: | Hui Qi, M.D | Shen Zhen People's Hospital |
Responsible Party: | Shenzhen People's Hospital |
ClinicalTrials.gov Identifier: | NCT03948828 |
Other Study ID Numbers: |
ShenzhenPH BTR-003 |
First Posted: | May 14, 2019 Key Record Dates |
Last Update Posted: | May 14, 2019 |
Last Verified: | May 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Endometriosis NK cell therapy |
Endometriosis |