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

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.

Study Overview

• Status: Completed
• Conditions: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Urticaria
• Intervention / Treatment: Biological: Autologous mesenchymal stem cell

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Turkey
  • Manisa, Turkey
    • Celal Bayar University, Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: 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.; Other Names: Autologous adipose tissue derived mesenchymal stem cell
No Intervention: Control patients; The patients who treated with the conventional therapy for urticaria, but not treat with mesenchymal stem cell.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Celal Bayar University
• Collaborators: The Scientific and Technological Research Council of Turkey; Acıbadem Labcell
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2017
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): July 15, 2018

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Mesenchymal stem cell; Chronic autoimmune urticaria
• Additional Relevant MeSH Terms: Hypersensitivity, Immediate; Skin Diseases, Vascular; Hypersensitivity; Skin Diseases; Autoimmune Diseases; Immune System Diseases; Urticaria; Chronic Urticaria
• Other Study ID Numbers: TUBITAK-1001-215S612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No