Clinical Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- SLEDAI-2000 score
研究概览
简要总结
To investigate the safety and efficacy of umbilical cord mesenchymal stem cell transplantation in patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN).
详细描述
Systemic lupus erythematosus (SLE) is a multisystem autoimmune disease. Lupus nephritis (LN) is one of the most serious complications of SLE. The current clinical treatments of LN mainly include steroids and immunosuppressive drugs, but drug side effects are obvious.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the 1997 American College of Rheumatology (ACR) classification criteria of SLE.
- •age 18-60 years.
- •of either sex and of any ethnicity.
- •Lupus nephritis (LN) group: (1) Receiving more than 6 months of regular treatment, 24-hour urine protein ≥ 1.0 g, serum creatinine ≥1.5 mg/dL; (2) renal biopsy: class III, IV or V LN included, and class VI excluded.
- •After conventional treatment (glucocorticoid therapy and immunosuppressive drugs) prior to grouping, SLEDAI scores ≥
- •Receiving 12 months of treatment while using birth control.
- •Provision of informed consent.
排除标准
- •Poor blood pressure control by drug treatment (≥ 160/100 mmHg)
- •Abnormal hepatic function (a 3-fold increase in alanine aminotransferase level relative to normal liver).
- •Renal failure (glomerular filtration rate < 15 mL/min/1.73 m2).
- •Severe heart and lung failure, or injury to other important organs
- •Uncontrollable infection.
- •Having not taken biological agents for 6 months.
- •Pregnant or lactating women, or those women who are trying to get pregnant or those men who are trying to make their partners pregnant.
结局指标
主要结局
SLEDAI-2000 score
时间窗: changes of month 3, month 6, month 9 and month 12 after treatment
The SLEDAI 2000 is a novel index that measures ≥ 50% in each of the 24 descriptors of SLEDAI-2K and generates a total score reflecting disease activity overall.
次要结局
- BILAG-2004 score(changes of month 3, month 6, month 9 and month 12 after treatment)
- Health Assessment Questionnaire (HAQ) score(changes of month 3, month 6, month 9 and month 12 after treatment)
研究者
Liu Jing
Chief Physician
The First Affiliated Hospital of Dalian Medical University