Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria

Conditions
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Urticaria, Autoimmune Diseases, Immune System Diseases, Skin Diseases

Intervention / Treatment
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* Biological: Autologous mesenchymal stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cell<br>Intravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg. | Biological: Autologous mesenchymal stem cell<br>* Intravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg.<br>* Other names: Autologous adipose tissue derived mesenchymal stem cell;|
| No Intervention: Control patients<br>The patients who treated with the conventional therapy for urticaria, but not treat with mesenchymal stem cell. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in weekly urticaria activity scores. | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ratios of peripheral blood inflammatory and anti-inflammatory cytokines. |  | 6 months | 
| The changes in the levels of peripheral blood anti-FcεRI autoantibody |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesenchymal stem cell, Chronic autoimmune urticaria