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Completed

NCT Number: NCT02824393

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Celal Bayar University, Medical School

Manisa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous mesenchymal stem cell

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.

Other names: Autologous adipose tissue derived mesenchymal stem cell

Primary outcomes

  1. Change from baseline in weekly urticaria activity scores.

    Time frame: 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 outcomes

  1. 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

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

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Manisa Celal Bayar University

Other

Collaborators

  • Acıbadem Labcell
  • The Scientific and Technological Research Council of Turkey

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2016
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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