Mesenchymal Stem Cell Transfusion for the Treatment of Refractory Lupus Nephritis
NCT Number: NCT06485648
Acronym: LN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Lupus Nephritis
Interventions: BIOLOGICAL: Umbilical cord mesenchymal stem cells|DRUG: Normal saline
Sponsor: Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-10-01

Summary:
Lupus nephritis (LN) is the most common and serious complication of systemic lupus erythematosus (SLE), which can lead to permanent kidney injury and uremia. At present, the combination of glucocorticoids and immunosuppressants is still the first line of clinical treatments. Only about 20%-30% of patients with LN can achieve a complete response. In addition, attainment of clinical remission does not necessarily reflect improvement in the kidney tissues, A substantial proportion of patients who show a clinical response to treatment still have histological findings in their kidney biopsy samples that are consistent with active kidney disease after clinical complete remission. Because of the complexity of refractory lupus nephritis, there is no uniform and effective treatment for them. Mesenchymal stem cells (MSCs) are a class of pluripotent stem cells, that can secrete hundreds of cytokines to participate in immune regulation, anti-inflammatory and anti-fibrosis processes, etc., so they have been actively explored for the treatment of autoimmune diseases which Including systemic lupus erythematosus and lupus nephritis recently. Therefore, MSCs have been considered as a potential therapeutic regimen for the treatment of refractory LN. Several clinical trials have been performed, but the results have been inconsistent and the outcome indicators of treatment were not verified by pathological findings. Therefore, this trial wishes to investigate whether MSCs can improve renal recovery in patients with refractory lupus nephritis and to evaluate the effectiveness of treatment by renal biopsy.

Primary Outcome Measures: Complete response rate, * Number of participants with reduction in content of Protein creatinine ratio \<0.5 g/g (50 mg/mmol) measured as the from of 24h-urine collection
* Stabilization or improvement in kidney function (±10%-15% of baseline)
* Within 6-12 month of starting therapy, but could take more than 12 month, Within 6-12 mo of starting therapy, but could take more than 12 mo|Partial response rate, * Number of participants with reduction in content of Protein creatinine ratio by at least 50% and to \<3 g/g (300 mg/mmol) measured from a 24-h urine collection
* Stabilization or improvement in kidney function (±10%-15% of baseline)
* Within 6-12 mo of starting therapy, Within 6-12 mo of starting therapy|No kidney response rate, • Number of participants with failure to achieve a partial or complete response within 6-12 mo of starting therapy, within 6-12 mo of starting therapy
Secondary Outcome Measures: Number of participants with varying degrees of LN activity according to SLEDAI 2000 and BILAG 2004., SLEDAI 2000: Systemic Lupus Erythematosus Disease Activity Index 2000 Totle score range from 0 to 105 Score 0-4 (Barely activity) Score 5-9 (Mild activity) Score 10-14 (Moderate activity) Score ≥15 (Severe activity)

BILAG 2004: British Isles Lupus Assessment Group 2004 Index The system consists of 86 clinical indicators, and each system is distinguished by A, B, C, D, and E respectively.

A, B, C, D, E is scored as follows: A=9, B=4, C=1, D=0, E=0. BILAG≥11 indicates active disease and BILAG\<11 indicates stable for the disease., within 6-12 mo of starting therapy|Number of participants with the recurrence within 48 weeks after complete and partial remission., within 6-12 mo of starting therapy|Number of participants with abnormal laboratory tests results for blood routine; blood biochemistry; urine routine; Immune indexes (ANA, Anti-dsDNA, C1q, C3, C4, etc.) and umor markers., within 6-12 mo of starting therapy|Overall survival rate and survival rate without renal involvement., within 6-12 mo of starting therapy