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

Early Phase 1

Completed

• Conditions: Urticaria; Autoimmune Diseases; Immune System Diseases; Skin Diseases
• Interventions: Biological: Autologous mesenchymal stem cell

• Registration Number: NCT02824393
• Lead Sponsor: Celal Bayar University

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.

Study Timeline

• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-06
• Study Start: 2017-03-03
• Primary Completion: 2018-05-15
• Status Verified: 2018-07
• Study Completion: 2018-07-15
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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).

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Mesenchymal stem cell	Autologous 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Celal Bayar University, Medical School; 🇹🇷 Manisa, Turkey