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Pilot Study for Cell Based Therapies in Patients With Asthma

This study has been completed.
Sponsor:
Collaborator:
Hannover Medical School
Information provided by:
Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT01087515
First received: March 12, 2010
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Asthma
Allergic Rhinitis
Other: Blood donation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Development and Validation of Magnetic Cell Separations Techniques Using a Good Manufacturing Practice (GMP) Grade Manufacturing Process for Clinical Applications and Generation of Pre-clinical Data

Further study details as provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:

Primary Outcome Measures:
  • Purity of MACS® and CliniMacs® BDCA-4 positive isolated plasmcytoid dendritic cells: Percentage of CD123/BDCA-2 expressing cells [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Blood donation Other: 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.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087515

Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine
Hannover Medical School
Investigators
Principal Investigator: Norbert Krug, MD Fraunhofer Institute for Toxicology and Experimental Medicine
  More Information

No publications provided

Responsible Party: Prof. Dr. Norbert Krug, Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier: NCT01087515     History of Changes
Other Study ID Numbers: 09/11 PILOCELL
Study First Received: March 12, 2010
Last Updated: November 8, 2011
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014