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
Allogeneic MSC transplantation has shown significant efficacy and good safety in the treatment of refractory autoimmune diseases such as lupus nephritis (LN), and has a broad application prospect. One of its mechanisms is that MSCs up-regulates the production of IL-2 and promotes the production of Treg cells. The breakthrough in this technology has brought new hope for patients with autoimmune diseases. Some small sample studies at home and abroad have shown that low-dose IL-2 can be used to treat LN. Recently, the research team found that a single dose of IL-2 showed a longer effect than repeated low-dose MSCs. However, there is still a lack of prospective randomized studies to confirm that the efficacy of allogeneic MSC is better than that of low-dose IL-2. Therefore, carrying out this prospective randomized study will make a real breakthrough in the clinical application of MSC in SLE, and open up a new field for the treatment of SLE for the benefit of mankind.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Human umbilical cord mesenchymal stem cells (1 × 10 \^6 cells / kg body weight, suspended in 30ml saline), intravenous drip once.
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.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
RECRUITINGResponse rates in both groups （CR and RR）
Complete response (CR): serum creatinine ≤ 1.2 mg/dl or ≤125% of baseline, and ratio of protein in morning urine to creatinine \<0.5 or 24-hour urine protein quantification \< 0.5 g, and prednisone reduced to ≤10 mg/day (or equivalent). Partial response (PR): if serum creatinine and ratio of protein in morning urine to creatinine (or 24-hour urine protein quantification) were abnormal before treatment, both improved by \>30% after treatment, and there were no other indicators of deterioration; If only the ratio of protein in morning urine to creatinine (or 24-hour urine protein quantification) is abnormal before treatment, the improvement is \>50% after treatment.
Time frame: 24 Weeks
Time for both groups of subjects to achieve PR and CR
Complete response (CR): serum creatinine ≤ 1.2 mg/dl or ≤125% of baseline, and ratio of protein in morning urine to creatinine \<0.5 or 24-hour urine protein quantification \< 0.5 g, and prednisone reduced to ≤10 mg/day (or equivalent). Partial response (PR): if serum creatinine and ratio of protein in morning urine to creatinine (or 24-hour urine protein quantification) were abnormal before treatment, both improved by \>30% after treatment, and there were no other indicators of deterioration; If only the ratio of protein in morning urine to creatinine (or 24-hour urine protein quantification) is abnormal before treatment, the improvement is \>50% after treatment.
Time frame: 24 Weeks
SRI response status
SRI response status at Week 24 Clinical efficacy will be measured using the SLE Responder Index (SRI), a composite endpoint that incorporates SLEDAI-2K, BILAG 2004, and a visual analog scale (VAS) of physician-rated disease activity to determine patient improvement.
Time frame: 24 Weeks
SLEDAI-2K score and change from baseline
To describe the effect of treatment with MSCs or IL-2 using patient reported outcomes
Time frame: Baseline, Week 4, 8, 16, 20 and 24
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BILAG-2004 score and change from baseline
To describe the effect of treatment with MSCs or IL-2 using patient reported outcomes
Time frame: Baseline, Week 4, 8, 16, 20 and 24
Hormone dosage and change from baseline
To describe the effect of treatment with MSCs or IL-2 using dose of hormones in patients
Time frame: Baseline, Week 4, 8, 16, 20 and 24
Patient incidence of Treatment-Emergent Adverse Events
To characterize the safety of MSCs and IL-2
Time frame: 24 Weeks
Patient incidence of Serious adverse events
To characterize the safety of MSCs and IL-2
Time frame: 24 Weeks
Number of patients with significant changes in laboratory values
To characterize the safety of MSCs and IL-2
Time frame: 24 Weeks
Number of patients with significant changes in vital signs
To characterize the safety of MSCs and IL-2
Time frame: 24 Weeks