Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Scientific and Technological Research Council of Turkey | OTHER |
| Acıbadem Labcell | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cell | Experimental | Intravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg. |
|
| Control patients | No Intervention | The patients who treated with the conventional therapy for urticaria, but not treat with mesenchymal stem cell. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous mesenchymal stem cell | Biological | Intravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg. |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alper Tunga Özdemir, PhD | Ege University, Institute of Health Sciences, Department of Stem Cell, Izmir/TURKEY | Principal Investigator |
| Ercüment Ovalı, Prof. Dr. | Acıbadem Labcell, Istanbul/TURKEY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celal Bayar University, Medical School | Manisa | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012871 | Skin Diseases |
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D017445 | Skin Diseases, Vascular |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |