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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01790269
Other study ID # NKcells Gilenya®-treated MS
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 2013
Est. completion date August 2018

Study information

Verified date July 2021
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Data on fingolimod effects on NK cells are so far conflicting. A longitudinal study on fingolimod treated kidney transplant patients showed that NK cells were not influenced in any of the treatment groups. However, more recent reports indicate an increased frequency of NK cells in peripheral blood and CSF of MS patients treated with fingolimod and a relative reduction of immature CD56bright NK cells in fingolimod-treated MS patients. It has been demonstrated that the expression of NK cell relevant sphingosine 1-phosphate (S1P) receptors seems to increase during NK cell maturation. Thus, different NK cell sub-types may response differently to S1P-receptor agonist such as fingolimod. Therefore, the investigators aim to investigate longitudinally (baseline vs. treatment) the effects of fingolimod on NK cell maturation/differentiation.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Charité Universitätsmedizin Berlin Berlin

Sponsors (2)

Lead Sponsor Collaborator
Charite University, Berlin, Germany Dr. Carmen Infante-Duarte

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Status of NK cell maturation Status of NK cell maturation, defined as the ratio immature NK cells / total NK cells (percentage), before fingolimod treatment vs. after 12 months of treatment (V4). The maturation status is determined by the expression of certain cell surface markers which can be evaluated by flow cytometry. Baseline to (12 months) treatment
Secondary NK cell frequency NK cell frequency at all time points (determined by flow cytometry) Baseline, +1 mo, +3 mo, +6 mo, +12 mo
Secondary Percentage immature NK cells/total NK cells Percentage immature NK cells/total NK cells at all time points Baseline, +1 mo, +3 mo, +6 mo, +12 mo
Secondary NK cell activation NK cell activation (expression of certain cell surface markers determined by flow cytometry) at all time points Baseline, +1 mo, +3 mo, +6 mo, +12 mo
Secondary NK cell maturation and activation NK cell maturation and activation in relation to clinically detectable therapeutic effect (determined a) by annual relapse rate over study period vs. annualized relapse rate in the preceding two years; and b) by the development of disability (determined by Expanded Disability Status Scale (EDSS) during treatment with fingolimod) Baseline, +1 mo, +3 mo, +6 mo, +12 mo
Secondary NK cell cytotoxicity and the cytokine production NK cell cytotoxicity and the cytokine production (IL-15, IL-13, IL-5, GM-CSF, IFN-gamma) Baseline, +1 mo, +3 mo, +6 mo, +12 mo
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