Pilot Study for Cell Based Therapies in Patients With Asthma (NCT01087515) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study for Cell Based Therapies in Patients With Asthma
20 participantsStarted 2010-03
Plain-language summary
The aim of this study is to investigate the immunomodulatory potential of Isolated Plasmacytoide Dendritic Cells (pDCs) and Regulatory T-cells (TREGs) isolated with clinical grade magnetic bead isolations techniques (MACS®) on the antigen presenting cell-induced proliferation of lymphocytes after allergen uptake in an in vitro cell culture system.
Who can participate
Age range18 Years – 60 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male subjects suffering from allergic rhinitis and/or allergic asthma against timothy grass pollen (phleum pratense) and/or house dust mite.
* 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:
* History of lower respiratory tract infection and /or exacerbation of asthma within four weeks prior to the informed consent visit
* 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 immunothera…
What they're measuring
1
Purity of MACS® and CliniMacs® BDCA-4 positive isolated plasmcytoid dendritic cells: Percentage of CD123/BDCA-2 expressing cells
Trial details
NCT IDNCT01087515
SponsorFraunhofer-Institute of Toxicology and Experimental Medicine