Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from baseline in weekly urticaria activity scores.
研究概览
简要总结
The aim of this study is to determine whether autologous adipose tissue derived Mesenchymal Stem Cells of treatment for chronic autoimmune urticaria is safe and effective.
详细描述
Chronic urticaria is a distressful disease, which negatively affects the quality of life. Pathogenesis isn't exactly clear, treatment is relatively palliative and results are usually suboptimal. 30-40% of the patients have autoimmune origin. Patients are forced to use immunosuppressive treatments which have systemic effects. Some of the treatments have effects as severe as the disease itself.
Mesenchymal stem cells (MSCs) are the most common used cells in clinical trials. These cells can provide efficient immunosuppression in severe conditions like immunosuppressive resistant Graft versus Host Disease. With this study at the first time and quite a different approach from conventional treatment, it will be tried an experimental treatment that used in the MSCs for the chronic autoimmune urticaria patients without of definitive treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with chronic autoimmune urticaria (at least six months before)
- •Patients who have >20 and over of urticaria activity score [according to European Academy of Allergy and Clinical Immunology (EAACI) / Global Allergy and Asthma European Network (GALEN) guidelines].
- •Patients who capable of own daily findings record.
- •Patients who could not be controlled despite the use of a treatment agent in the fourth step for 3 months (according to EAACI / GALEN guidelines).
排除标准
- •Patients who have heart, liver or renal failure.
- •Patients who have epilepsy, cerebrovascular or ischemic attack.
- •Patients who have atopic dermatitis or another underlying itchy skin disease.
- •Patients who have parasitic infection.
- •Patients who have antibiotic allergy.
- •History of malignancy.
研究组 & 干预措施
Mesenchymal stem cell
Intravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg.
干预措施: Autologous mesenchymal stem cell (Biological)
Control patients
The patients who treated with the conventional therapy for urticaria, but not treat with mesenchymal stem cell.
结局指标
主要结局
Change from baseline in weekly urticaria activity scores.
时间窗: 6 months
The weekly urticaria activity scores will be assessed according to European Academy of Allergy and Clinical Immunology (EAACI) / Global Allergy and Asthma European Network (GALEN) guidelines.
次要结局
- The changes in ratios of peripheral blood inflammatory and anti-inflammatory cytokines.(6 months)
- Follow-up of the mesenchymal stem cell treatment-related side effects according to World Health Organisation (WHO) Toxicity Grading Scale for Determining The Severity of Adverse Events.(12 months)
- The changes in the ratios of peripheral blood cluster of differentiation 4 (CD4) T cell subsets.(6 months)
- The changes in the levels of peripheral blood anti-FcεRI autoantibody(6 months)
研究者
Cengiz Kırmaz
Professor Doctor (MD)
Celal Bayar University