Clinical trial NCT02824393: Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria
Official title: Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Urticaria
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Keywords: Mesenchymal stem cell
Chronic autoimmune urticaria
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
name: Acıbadem Labcell
First posted: 2016-07-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in weekly urticaria activity scores.
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
measure: The changes in the ratios of peripheral blood cluster of differentiation 4 (CD4) T cell subsets.
timeFrame: 6 months
measure: The changes in ratios of peripheral blood inflammatory and anti-inflammatory cytokines.
timeFrame: 6 months
measure: The changes in the levels of peripheral blood anti-FcεRI autoantibody
timeFrame: 6 months
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Celal Bayar University, Medical School
Study officials:
affiliation: Ege University, Institute of Health Sciences, Department of Stem Cell, Izmir/TURKEY
name: Alper Tunga Özdemir, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Acıbadem Labcell, Istanbul/TURKEY
name: Ercüment Ovalı, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: