The document discusses a study on plasmonic nanophotothermic therapy for treating atherosclerosis, highlighting its potential to significantly reduce plaque burden compared to traditional therapies. The study involved 180 patients and demonstrated notable improvements in atheroma volume and cardiovascular outcomes with the new treatment method. The findings suggest plasmonic resonance therapy may effectively lead to regression of coronary atherosclerosis.

1. PLASMONIC NANOPHOTOTHERMIC THERAPY OF
ATHEROSCLEROSIS (NANOM FIM,
NCT01270139)
Presented by:
Emmanuel E. Egom, MSc, MD, PhD, MRCP (UK)
At the Academy of Applied Pharmaceutical Sciences (AAPS) in Toronto
12/19/2014

2. OVERVIEW
 Background
 Hypothesize
 Study Design
 Results
 Conclusion

3. BACKGROUND
 Cardiovascular disease is one of the main cause of disability and
death worldwide.
 The underlying cause generally is atherosclerosis.
 Some modern angioplasty techniques generally just manipulate the
form of the plaque and have some clinical and technical restrictions,
relatively high complication rate and restenosis risk.

4.  Prevention of atherosclerosis and treatment of its complications
remain a clinical challenge (risk factor modification or systemic drug
therapy e.g. statin).
 The reversal of atherogenesis becomes a new more attractive target
for the progress of cardiovascular therapy, and coronary device
development

5.  Numerous devices utilizing heat and high-energy light such as laser
technology, radio frequency sparking have been recently described
as the applications to treat atheroma.
 Plasmonic photothermal therapy (PPTT) is the novel invasive
approach in cardiology
 Treatment with PPTT may induce plaque burden reduction up to 79.4
mm3 (up to 6.38 mm3 with Statins)

6. HYPOTHESIZE
 Nanoburning may demolish and reverse the plaque especially
in combination with stem cell technologies with promising
functional restoration of the vessel wall.
 First-in-man nanotechnology trial assessing potent clinical
opportunities, efficacy and safety of such novel technique for
angioplasty as plasmonic atherodestruction.

7. STUDY DESIGN
 Allocation: Randomized in a 1:1:1 ratio
 Endpoint Classification: Safety/Efficacy Study
 Intervention Model: Parallel Assignment
 Masking: Double Blind (Subject, Investigator)
 Primary Purpose: Treatment

8. RECRUITMENT INFORMATION
 Recruitment Status: Completed
 Enrollment: 180
 Completion Date: June 2012
 Eligibility Criteria:
Inclusion Criteria: age 45-65 years old, male and female with single-
or multi-vessel CAD with flow-limiting lesions
Exclusion Criteria: non-compliance, history of myocardial infarction,
unstable anginaor other disrhythmias, stroke.
 Location Countries: Russian Federation

9. INTERVENTION
 (1) nano-intervention with delivery of silica-gold NP in mini-
surgery implanted bioengineered on-artery patch (n=60)
 (2) nano-intervention with delivery of silica-gold iron-bearing
NP with targeted micro-bubbles or stem cells in hands of
magnetic navigation system (n=60)
 (3) stent implantation (n=60)

10. STUDY ARM (S)
 Experimental: Nano group 60 patients undergoing
transplantation of nanoparticles
 Active Comparator: Ferro group 60 patients in undergoing
intracoronary infusion of allogenious stem cells or CD68
targeted micro-bubbles pre-cultivated in the medium with iron-
bearing nanoparticles

11. RESULTS
 The mean TAV reduction at 12 months in Nano group was 60.3 mm3
(p<0.05).
 The reduction of the PAV (per cent atheroma volume) post-
procedure/ at 12-month follow-up was 12.6/44.8%, 13.1/ 43.2%,
20.2/ 22.7% (p<0.05) in groups respectively.

12.  The increase of minimal lumen diameter from baseline to post-
procedure/ at 12-month follow-up was 5.9/ 63.6%, 21.2/ 63.8%, 56.2/
62.4% (p<0.05) in groups respectively.
 The analysis of the event free survival of the ongoing clinical follow-
up shows the significantly lower risk of cardiovascular death in Nano
group if compare with others (91.7% vs 81.7% and 80% respectively;
p<0.05).

13. CONCLUSION
 Atherodestruction in hands of plasmonic resonance of the
silica-gold NP resulted in significant regression of coronary
atherosclerosis.

14. Thank you
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