NCT03798028Unknown不适用
The Effects and Safety of Mesenchymal Stem Cells in the Treatment of Moderate/Severe Rheumatoid Arthritis， a Multicenter Randomized Controlled Clinical Study
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年12月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
研究概览
简要总结
This study evaluates the safety and therapeutic effects of single-dose human umbilical cord blood mesenchymal stem cells (UC-MSCs) on the adult patients with moderate/severe Rheumatoid Arthritis accompany with anemia or/and Interstitial pulmonary disease. Half of participants will receive UC-MSCs and keep the present medication,while the other half will receive a placebo and keep the present medication.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill 2010 ACR/ the European League Against Rheumatism (EULAR) classification criteria or the 1987 ACR classification criteria.
- •Age limits:18 to 70 years old.
- •Freely given informed consent.
- •Disease Activity Score (DAS) 28≥3.2 或 Simple Disease Activity Index (SDAI)>11.0 或 Clinical Disease Activity Index (CDAI) >10.
- •Hemoglobin < 90 g/L and/or interstitial lung disease shown in high resolution CT.
- •Poor response to current treatment. The current treatment refers to receive the medicines (including Leflunomide, Methotrexate, Sulphasalazine, Hydroxychloroquine, Cyclosporine A,and Tacrolimus, alone or in combination ) for 3 months, and maintain the stable-dose of drugs for at least 1 month.
- •More than 3 months and a stable dose for at least 1 month are required if glucocorticoid is used. The dose of glucocorticoid is less than or equal to10mg/ day of prednisone.
排除标准
- •Participants who received glucocorticoid therapy by intra-articular injection within 1 week.
- •Glucocorticoid that participants received is more than 10 mg/day of prednisone within 1 months.
- •Complication with other connective tissue disease (except for Sjogren syndrome) .
- •Participants with chronic and acute infection (bacteria, virus and parasite,etc.).
- •Participants with acute and chronic tuberculosis infection.
- •Malignant tumors or participants with a family history of malignant tumors.
- •Participants have a family history of allergic conditions.
- •Participants infected by Hepatitis B Virus(HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus （HIV）.
- •Participants suffer from central nervous system demyelinating disease or multiple sclerosis (MS) currently or in the past.
- •Participants received live vaccines with 3 months.
- •Drug abuse and alcoholism.
- •Participants with severe mental or neurological disorders that affect informed consent and/or the presentation or observer of adverse events.
- •Participants with pregnant or in breast-feeding, and patients who has a pregnancy plan within 1 year.
- •Participants received stem cell therapy in the past.
- •Participants received any biological agents within 3 months.
- •Anemia (such as anemia with dysplasia) and interstitial lung disease for other reasons.
- •Participants with cardiovascular and cerebrovascular damage, such as thrombosis.
- •Participants taking drugs that affect the test for blood and lung.
- •Participants taking any traditional Chinese medicine.
- •Participants taking immune modulators such as Transfer Factor, Thymosin and Intravenous Immunoglobulin (IVIG), and so on.
- •Other cases that participants are considered by investigator that they did not meet the requirements for enrollment.
研究组 & 干预措施
no UC-MSCs treatment
No Intervention
the participants will receive the placebo in combined with the present treatment.
UC-MSCs treatment
Experimental
the participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment.
干预措施: UC-MSCs (Biological)
结局指标
主要结局
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
时间窗: 24 weeks
The HGB increases by 10g compared to the baseline is considered improvement.
Improvement rate of forced vital capacity (FVC) and/or carbon monoxide diffusing capacity (DLCO) compared to baseline.
时间窗: 24 weeks
FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement.
次要结局
- Improvement rate of forced vital capacity (FVC) and/or carbon monoxide(12 weeks)
- Improvement rate of blood routine hemoglobin (HGB) compared to baseline.(12 weeks)
- Improvement of 6-minute walking distance compared to baseline.(12 weeks and 24 weeks)
- White blood cell count and platelet count improved compared to the baseline.(12 weeks and 24 weeks)
- The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70.(12 weeks and 24 weeks)
- Image improvement of lung on high resolution CT.(24 weeks)
研究者
研究点 (1)
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