NCT02824393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

March 3, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

June 29, 2016

Last Update Submit

July 17, 2018

Conditions

UrticariaAutoimmune DiseasesImmune System DiseasesSkin Diseases

Keywords

Mesenchymal stem cellChronic autoimmune urticaria

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

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

    6 months

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

    6 months

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

    6 months

Study Arms (2)

Mesenchymal stem cell

EXPERIMENTAL

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

Control patients

NO INTERVENTION

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

Interventions

Autologous mesenchymal stem cellBIOLOGICAL

Intravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg.

Also known as: Autologous adipose tissue derived mesenchymal stem cell
Mesenchymal stem cell

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celal Bayar University, Medical School

Manisa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

UrticariaAutoimmune DiseasesImmune System DiseasesSkin DiseasesChronic Urticaria

Condition Hierarchy (Ancestors)

Skin Diseases, VascularSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor (MD)

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 6, 2016

Study Start

March 3, 2017

Primary Completion

May 15, 2018

Study Completion

July 15, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

Locations

TU(1)