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

Autoimmune Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824393
• Other study ID #: TUBITAK-1001-215S612
• Status: Completed
• Phase: Early Phase 1
• Start date: March 3, 2017
• Est. completion date: July 15, 2018

Study information

• Verified date: July 2018
• Source: Celal Bayar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Immune System Diseases
• Skin Diseases
• Urticaria

Intervention

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.

Locations

Country	Name	City	State
Turkey	Celal Bayar University, Medical School	Manisa

Sponsors (3)

Lead Sponsor	Collaborator
Celal Bayar University	Acibadem Labcell, The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The changes in the ratios of peripheral blood cluster of differentiation 4 (CD4) T cell subsets.		6 months
Secondary	The changes in ratios of peripheral blood inflammatory and anti-inflammatory cytokines.		6 months
Secondary	The changes in the levels of peripheral blood anti-FceRI autoantibody		6 months