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

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ClinicalTrials.gov Identifier: NCT02824393
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
The Scientific and Technological Research Council of Turkey
Acıbadem Labcell
Information provided by (Responsible Party):
Cengiz Kırmaz, Celal Bayar University

Tracking Information
First Submitted Date  ICMJE June 29, 2016
First Posted Date  ICMJE July 6, 2016
Last Update Posted Date July 18, 2018
Actual Study Start Date  ICMJE March 3, 2017
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02824393 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
  • 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 ]
  • The changes in the ratios of peripheral blood cluster of differentiation 4 (CD4) T cell subsets. [ Time Frame: 6 months ]
  • The changes in ratios of peripheral blood inflammatory and anti-inflammatory cytokines. [ Time Frame: 6 months ]
  • The changes in the levels of peripheral blood anti-FcεRI autoantibody [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria
Official Title  ICMJE Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Urticaria
  • Autoimmune Diseases
  • Immune System Diseases
  • Skin Diseases
Intervention  ICMJE 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 Name: Autologous adipose tissue derived mesenchymal stem cell
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Autologous mesenchymal stem cell
  • No Intervention: Control patients
    The patients who treated with the conventional therapy for urticaria, but not treat with mesenchymal stem cell.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2018)
10
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2016)
20
Actual Study Completion Date  ICMJE July 15, 2018
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02824393
Other Study ID Numbers  ICMJE TUBITAK-1001-215S612
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Cengiz Kırmaz, Celal Bayar University
Study Sponsor  ICMJE Celal Bayar University
Collaborators  ICMJE
  • The Scientific and Technological Research Council of Turkey
  • Acıbadem Labcell
Investigators  ICMJE
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
PRS Account Celal Bayar University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP