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

NCT ID: NCT02824393

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-03
• Study Completion Date: 2018-07-15

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.

Conditions

Urticaria; Autoimmune Diseases; Immune System Diseases; Skin Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Autologous mesenchymal stem cell

Intervention Type: 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.

Control patients

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Autologous adipose tissue derived mesenchymal stem cell

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Acıbadem Labcell

OTHER

Sponsor Role: collaborator

Celal Bayar University

OTHER

Sponsor Role: lead

Responsible Party

Cengiz Kırmaz

Professor Doctor (MD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alper Tunga Özdemir, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Ercüment Ovalı, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Acıbadem Labcell, Istanbul/TURKEY

Locations

Celal Bayar University, Medical School

Manisa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TUBITAK-1001-215S612

Identifier Type: -

Identifier Source: org_study_id