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eukapheresis of healthy volunteer donors for T cell study and TolDC production process validations

Conditions
Hematological and immunological diseases
10018849
10027665
Registration Number
NL-OMON52474
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

-Age > 17 years
-Able to comprehend and give signed informed consent

Exclusion Criteria

-Any concurrent systemic comorbidity
-Symptoms of infectious disease in the 3 weeks prior to donation
-Vaccination of any kind in the 3 weeks prior to donation
-Requirement for additional infectious disease screening
-Insufficient vascular access for the purpose of the apheresis procedure
-Pregnancy
-Any condition that in the opinion of the IHB medical team might interfere with
the safe completion of an apheresis procedure

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Successful collection of sufficient numbers of MNC for T cell or monocyte<br /><br>isolation for the purpose of testruns and validation procedures for T cell or<br /><br>tolerogenic dendritic cell studies.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>None</p><br>
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