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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 : Recruiting
First Posted : July 6, 2016
Last Update Posted : June 7, 2017
Sponsor:
Collaborators:
The Scientific and Technological Research Council of Turkey
Acıbadem Labcell
Information provided by (Responsible Party):
Cengiz Kırmaz, Celal Bayar University

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.

Condition or disease Intervention/treatment Phase
Urticaria Autoimmune Diseases Immune System Diseases Skin Diseases Biological: Autologous mesenchymal stem cell Early Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria
Actual Study Start Date : March 3, 2017
Estimated Primary Completion Date : July 15, 2018
Estimated Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
U.S. FDA Resources

Arm Intervention/treatment
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.
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
No Intervention: Control patients
The patients who treated with the conventional therapy for urticaria, but not treat with mesenchymal stem cell.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824393


Contacts
Contact: Cengiz Kırmaz, Prof.Dr. +90 532 415 0831 ckirmaz@yahoo.com
Contact: Rabia Bilge Özgül Özdemir, MD +90 505 391 1471 rabiabilgeozgul@yahoo.com

Locations
Turkey
Celal Bayar University, Medical School Recruiting
Manisa, Turkey
Contact: Cengiz Kırmaz, Prof. Dr.    +90 532 415 0831    ckirmaz@yahoo.com   
Contact: Rabia Bilge Özgül Özdemir, MD    +90 505 391 14 71 ext Özgül Özdemir    rabiabilgeozgul@yahoo.com   
Principal Investigator: Alper Tunga Özdemir, PhD         
Principal Investigator: Ercüment Ovalı, Prof. Dr.         
Sub-Investigator: Ercüment Ölmez, Prof. Dr.         
Sub-Investigator: Hakan Kerem, Associate Prof.         
Sponsors and Collaborators
Celal Bayar University
The Scientific and Technological Research Council of Turkey
Acıbadem Labcell
Investigators
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

Responsible Party: Cengiz Kırmaz, Professor Doctor (MD), Celal Bayar University
ClinicalTrials.gov Identifier: NCT02824393     History of Changes
Other Study ID Numbers: TUBITAK-1001-215S612
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cengiz Kırmaz, Celal Bayar University:
Mesenchymal stem cell
Chronic autoimmune urticaria

Additional relevant MeSH terms:
Urticaria
Autoimmune Diseases
Skin Diseases
Immune System Diseases
Skin Diseases, Vascular
Hypersensitivity, Immediate
Hypersensitivity