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

Primary Purpose

Urticaria, Autoimmune Diseases, Immune System Diseases

Status

Completed

Phase

Early Phase 1

Locations

Turkey

Study Type

Interventional

Intervention

Autologous mesenchymal stem cell

About this trial

This is an interventional treatment trial for Urticaria focused on measuring Mesenchymal stem cell, Chronic autoimmune urticaria

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients diagnosed with chronic autoimmune urticaria (at least six months before)
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].
Patients who capable of own daily findings record.
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:

Patients who have heart, liver or renal failure.
Patients who have epilepsy, cerebrovascular or ischemic attack.
Patients who have atopic dermatitis or another underlying itchy skin disease.
Patients who have parasitic infection.
Patients who have antibiotic allergy.
History of malignancy.

Sites / Locations

Celal Bayar University, Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mesenchymal stem cell

Control patients

Arm Description

Intravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg.

The patients who treated with the conventional therapy for urticaria, but not treat with mesenchymal stem cell.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

The changes in the ratios of peripheral blood cluster of differentiation 4 (CD4) T cell subsets.

The changes in ratios of peripheral blood inflammatory and anti-inflammatory cytokines.

The changes in the levels of peripheral blood anti-FcεRI autoantibody

Full Information

NCT ID

NCT02824393

First Posted

June 29, 2016

Last Updated

July 17, 2018

Sponsor

Celal Bayar University

Collaborators

The Scientific and Technological Research Council of Turkey, Acıbadem Labcell

1. Study Identification

Unique Protocol Identification Number

NCT02824393

Brief Title

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

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

March 3, 2017 (Actual)

Primary Completion Date

May 15, 2018 (Actual)

Study Completion Date

July 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Celal Bayar University

Collaborators

The Scientific and Technological Research Council of Turkey, Acıbadem Labcell

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urticaria, Autoimmune Diseases, Immune System Diseases, Skin Diseases

Keywords

Mesenchymal stem cell, Chronic autoimmune urticaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mesenchymal stem cell

Arm Type

Experimental

Arm Description

Intravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg.

Arm Title

Control patients

Arm Type

No Intervention

Arm Description

The patients who treated with the conventional therapy for urticaria, but not treat with mesenchymal stem cell.

Intervention Type

Biological

Intervention Name(s)

Autologous mesenchymal stem cell

Other Intervention Name(s)

Autologous adipose tissue derived mesenchymal stem cell

Intervention Description

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 Measure Information:

Title

Change from baseline in weekly urticaria activity scores.

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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.

Time Frame

12 months

Title

The changes in the ratios of peripheral blood cluster of differentiation 4 (CD4) T cell subsets.

Time Frame

6 months

Title

The changes in ratios of peripheral blood inflammatory and anti-inflammatory cytokines.

Time Frame

6 months

Title

The changes in the levels of peripheral blood anti-FcεRI autoantibody

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients diagnosed with chronic autoimmune urticaria (at least six months before) 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]. Patients who capable of own daily findings record. 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: Patients who have heart, liver or renal failure. Patients who have epilepsy, cerebrovascular or ischemic attack. Patients who have atopic dermatitis or another underlying itchy skin disease. Patients who have parasitic infection. Patients who have antibiotic allergy. History of malignancy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alper Tunga Özdemir, PhD

Organizational Affiliation

Ege University, Institute of Health Sciences, Department of Stem Cell, Izmir/TURKEY

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ercüment Ovalı, Prof. Dr.

Organizational Affiliation

Acıbadem Labcell, Istanbul/TURKEY

Official's Role

Principal Investigator

Facility Information:

Facility Name

Celal Bayar University, Medical School

City

Manisa

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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