Autoimmune Diseases, Immune System Diseases, Skin Diseases, Urticaria
Conditions
Keywords
Mesenchymal stem cell, Chronic autoimmune urticaria
Brief summary
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
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.
Interventions
BIOLOGICALAutologous 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.
Sponsors
The Scientific and Technological Research Council of Turkey
Acıbadem Labcell
Celal Bayar University
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with chronic autoimmune urticaria (at least six months before) 2. Patients who have \>20 and over of urticaria activity score \[according to European Academy of Allergy and Clinical Immunology (EAACI) / Global Allergy and Asthma European Network (GALEN) guidelines\]. 3. Patients who capable of own daily findings record. 4. 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
1. Patients who have heart, liver or renal failure. 2. Patients who have epilepsy, cerebrovascular or ischemic attack. 3. Patients who have atopic dermatitis or another underlying itchy skin disease. 4. Patients who have parasitic infection. 5. Patients who have antibiotic allergy. 6. History of malignancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in weekly urticaria activity scores. | 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. |
Secondary
| Measure | 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed