Pilot Study for Cell Based Therapies in Patients With Asthma
NCT ID: NCT01087515
Last Updated: 2011-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2010-03-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Blood donation
Blood donation
In experimental part 1 to generate preclinical data 250 ml of blood will be donated at day 1 by 10 subjects to induce allergen presenting cells (APCs).
In experimental part 2 to transfer the isolation of pDC or TREGs to a GMP (good manufacturing Practice) compliant clinical grade isolation system, leukapheresis will be performed with the blood from 5 subjects.
In experimental part 3 for potency testing of the clinical grade isolation system of pDC or TREGs, 250 ml of blood will be collected at day 1 from 3 subjects.
Interventions
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Blood donation
In experimental part 1 to generate preclinical data 250 ml of blood will be donated at day 1 by 10 subjects to induce allergen presenting cells (APCs).
In experimental part 2 to transfer the isolation of pDC or TREGs to a GMP (good manufacturing Practice) compliant clinical grade isolation system, leukapheresis will be performed with the blood from 5 subjects.
In experimental part 3 for potency testing of the clinical grade isolation system of pDC or TREGs, 250 ml of blood will be collected at day 1 from 3 subjects.
Eligibility Criteria
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Inclusion Criteria
* age 18-60 years,
* Nonsmokers or smokers with a history of less than 1 pack years who have not smoked within the last 12 months.
* Positive skin prick test for timothy grass pollen (phleum pratense) and/or house dust mile within 12 months
* Able and willing to give written informed consent
* Hemoglobin ≥135 g/l
* Hematocrit ≥ 0,40
* Body weight ≥ 50 kg and Body Mass Index (BMI) within the range 19-32 kg/m²
Exclusion Criteria
* Febrile illness within four week before the trial examination
* Administration of oral, injectable, or dermal corticosteroids within the last 8 weeks or intranasal and/or inhaled corticosteroids within the last 4 weeks.
* Intake of methylxanthines, antihistamines, antileukotrienes, oral cromolyn sodium, or oral nedocromil sodium
* Past or present disease, which as judged by the investigator, may affect the outcome of this trial. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease, or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
* Specific immunotherapy (SIT) within the last two years prior to screening
* Participation in another clinical trial 30 days prior to enrollment
* Donation of more than 500 ml of blood in the preceding 9 weeks before the trial-examination
* Hemoglobin below the normal lower limit
* History of drug and/or alcohol abuse or dependence within 12 months of the trial
* Risk of non-compliance with trial procedures
* Suspected inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial
* Patient is tested human immunodeficiency virus (HIV)-1/2Ab, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab) positive
18 Years
60 Years
MALE
No
Sponsors
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Hannover Medical School
OTHER
Fraunhofer-Institute of Toxicology and Experimental Medicine
OTHER
Responsible Party
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Fraunhofer-Institute of Toxicology and Experimental Medicine
Principal Investigators
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Norbert Krug, MD
Role: PRINCIPAL_INVESTIGATOR
Fraunhofer Institute for Toxicology and Experimental Medicine
Other Identifiers
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09/11 PILOCELL
Identifier Type: -
Identifier Source: org_study_id