NCT01087515

Pilot Study for Cell Based Therapies in Patients With Asthma

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Asthma
• Allergic Rhinitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-03-16
• Last updated: 2011-11-09