The Study of Comparing the Efficacy and Safety of Human Umbilical Cord MSCs and Low-dose IL-2 in the Treatment of LN
NCT05631717 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2022-11-30
Summary
The purpose of this study is to compare the efficacy and safety of human umbilical cord mesenchymal stem cells and low-dose IL-2 in the treatment of LN
Conditions
Interventions
- BIOLOGICAL
-
Human umbilical cord mesenchymal stem cells
Human umbilical cord mesenchymal stem cells (1 × 10 \^6 cells / kg body weight, suspended in 30ml saline), intravenous drip once.
- DRUG
-
Interleukin-2
IL-2 (1×10\^6IU) will be injected subcutaneously every other day for 2 weeks (7 times), with an interval of 2 weeks. 4 weeks is a cycle, and three cycles were continuously treated for 12 weeks.
Sponsors & Collaborators
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
lead OTHER
Principal Investigators
-
Jun Liang, Doctor · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
-
Huayong Zhang, Doctor · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
-
Cheng Zhao, Doctor · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
-
Linyu Geng, Doctor · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
-
Xue Xu, Doctor · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
-
Xiaolei Ma, Doctor · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
-
Lihui Wen, Doctor · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
-
Saisai Huang, Doctor · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
-
Yunxia Yan, Master · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-01
- Primary Completion
- 2025-06-30
- Completion
- 2025-12-31
Countries
- China
Study Locations
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