Pilot Study for Cell Based Therapies in Patients With Asthma

NCT01087515 | Completed

• 1 other identifier: 09/11 PILOCELL
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthma; Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Purity of MACS® and CliniMacs® BDCA-4 positive isolated plasmcytoid dendritic cells: Percentage of CD123/BDCA-2 expressing cells

Study Arms (1)

Blood donation

OTHER

Other: Blood donation

Interventions

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.

Blood donation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead
• Hannover Medical School: collaborator

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic

Interventions

Blood Donation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Tissue and Organ Procurement; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Norbert Krug, MD

  Fraunhofer Institute for Toxicology and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 16, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 9, 2011

Record last verified: 2011-11