A Proof of Concept Study to Determine the Local Delivery and Efficacy of Nanocort
Status:
Unknown status
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
A promising strategy to reduce CVD is to directly target inflammation at the level of the
vessel wall. A potential drawback of anti-inflammatory strategies pertains to the thin line
between inhibiting 'inappropriate' inflammation versus inducing immuno-suppression. One of
the strategies to limit systemic immunosuppression is to strive for local delivery and
prolonged efficacy and low systemic burden of the drug by encapsulating the compound in
liposomes.
Liposome-encapsulated drugs efficiently target lesions and accumulate at a much higher extent
at desired areas of interest. Thus, local delivery and prolonged efficacy can be very
important tools to overcome the potential drawback anti-inflammatory drugs; namely an
inappropriate immune suppression. In the present project, the investigators therefore aim to
evaluate the delivery and superior efficacy of Nanocort above Prednison or placebo in
patients with peripheral artery disease due to atherosclerosis. Because these patients will
undergo an endarteriectomy the investigators will be able to collect atherosclerotic material
after drug administration and thus evaluate the local delivery and compare the effects of
Nanocort to Prednison or Placebo.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)