Pilot Study for Cell Based Therapies in Patients With Asthma
|ClinicalTrials.gov Identifier: NCT01087515|
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : November 9, 2011
|Condition or disease||Intervention/treatment|
|Asthma Allergic Rhinitis||Other: Blood donation|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||March 2010|
|Primary Completion Date :||November 2011|
|Study Completion Date :||November 2011|
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.
- Purity of MACS® and CliniMacs® BDCA-4 positive isolated plasmcytoid dendritic cells: Percentage of CD123/BDCA-2 expressing cells
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087515
|Principal Investigator:||Norbert Krug, MD||Fraunhofer Institute for Toxicology and Experimental Medicine|