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| Name | Class |
|---|---|
| Hannover Medical School | OTHER |
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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.
pDCs as well as TREGs will be co-incubated with generated allergen presenting cells, lymphocytes, and allergen. For in vitro experimentation immune cells will be collected from blood of grass mix or house dust mite sensitized atopic/asthmatic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood donation | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood donation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Purity of MACS® and CliniMacs® BDCA-4 positive isolated plasmcytoid dendritic cells: Percentage of CD123/BDCA-2 expressing cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Krug, MD | Fraunhofer Institute for Toxicology and Experimental Medicine | Principal Investigator |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000094345 | Blood Donation |
| ID | Term |
|---|---|
| D009927 | Tissue and Organ Procurement |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |