UrticariaEarly Phase 1NCT02824393
Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria
A Early Phase 1 study testing Autologous mesenchymal stem cell in people with Urticaria and Autoimmune Diseases, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Urticaria, Autoimmune Diseases, Immune System Diseases
- What is being tested?
- Autologous mesenchymal stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2017to 15 Jul 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Urticaria, Autoimmune Diseases, Immune System Diseases, Skin Diseases
- Being tested
- Autologous mesenchymal stem cell
- Keywords
- Mesenchymal stem cell, Chronic autoimmune urticaria
- Medical subject headings
- Urticaria, Autoimmune Diseases, Immune System Diseases, Skin Diseases, Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous mesenchymal stem cellBiological
Also called Autologous adipose tissue derived 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
The changes in the ratios of peripheral blood cluster of differentiation 4 (CD4) T cell subsets.
Measured: 6 months
The changes in ratios of peripheral blood inflammatory and anti-inflammatory cytokines.
Measured: 6 months
The changes in the levels of peripheral blood anti-FcεRI autoantibody
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start3 Mar 2017
- Primary completion15 May 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Acıbadem Labcell
- Responsible party
- Principal investigator, Cengiz Kırmaz, Manisa Celal Bayar University
- Investigators
- Alper Tunga Özdemir, PhD, Principal investigator, Ege University, Institute of Health Sciences, Department of Stem Cell, Izmir/TURKEYErcüment Ovalı, Prof. Dr., Principal investigator, Acıbadem Labcell, Istanbul/TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824393
- Sponsor's protocol ID
- TUBITAK-1001-215S612
- Status last verified
- Jul 2018
- First submitted
- 29 Jun 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria
- ClinicalTrials.gov ID
- NCT02824393
- Acronym / sponsor ID
- TUBITAK-1001-215S612
- Conditions
- Urticaria, Autoimmune Diseases, Immune System Diseases, Skin Diseases
- Keywords
- Mesenchymal stem cell, Chronic autoimmune urticaria
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Acıbadem Labcell
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell | Experimental | Biological: Autologous mesenchymal stem cellIntravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg. |
| Control patients | No intervention | –The patients who treated with the conventional therapy for urticaria, but not treat with mesenchymal stem cell. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous mesenchymal stem cellAlso: Autologous adipose tissue derived mesenchymal stem cellIntravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg. | Biological | Mesenchymal stem cell |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alper Tunga Özdemir, PhD principal investigator
Ege University, Institute of Health Sciences, Department of Stem Cell, Izmir/TURKEY
Ercüment Ovalı, Prof. Dr. principal investigator
Acıbadem Labcell, Istanbul/TURKEY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Autologous mesenchymal stem cell in people with Urticaria and Autoimmune Diseases, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in weekly urticaria activity scores. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.