Evidence map›Paper›PMID 30271140›Full record

ArticleInternational journal of nanomedicine2018

Pilot study on biocompatibility of fluorescent nanodiamond-(NV)-Z~800 particles in rats: safety, pharmacokinetics, and bio-distribution (part III).

Frank C Barone, Cezary Marcinkiewicz, Jie Li, Mark Sternberg, Peter I Lelkes, Dmitriy A Dikin, Peter J Bergold, Jonathan A Gerstenhaber, Giora Feuerstein

Abstract read
In one paragraph

Article in International journal of nanomedicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. A Perspective on Fluorescent Nanodiamond Bioimaging.Small (Weinheim an der Bergstrasse, Germany) · 2019
    Review
  9. Review Article: Synthesis, properties, and applications of fluorescent diamond particles.Journal of vacuum science and technology. B, Nanotechnology & microelectronics : materials, processing, measurement, & phenomena : JVST B · 2019
    Review
  10. Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Frank C BaroneDepartment of Neurology, SUNY Downstate Medical Center, Brooklyn, NY, USA.
Cezary MarcinkiewiczDepartment of Bioengineering, Temple University, College of Engineering, Philadelphia, PA, USA, cmarcink@temple.edu.
Jie LiDepartment of Neurology, SUNY Downstate Medical Center, Brooklyn, NY, USA.
Mark SternbergDebina Diagnostics Inc, Newtown Square, PA, USA, cmarcink@temple.edu.
Peter I LelkesDepartment of Bioengineering, Temple University, College of Engineering, Philadelphia, PA, USA, cmarcink@temple.edu.
Dmitriy A DikinDepartment of Mechanical Engineering, Temple University, Philadelphia, PA, USA.
Peter J BergoldDepartment of Neurology, SUNY Downstate Medical Center, Brooklyn, NY, USA.
Jonathan A GerstenhaberDepartment of Bioengineering, Temple University, College of Engineering, Philadelphia, PA, USA, cmarcink@temple.edu.
Giora FeuersteinDebina Diagnostics Inc, Newtown Square, PA, USA, cmarcink@temple.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe hereby report on studies aimed to characterize safety, pharmacokinetics, and bio-distribution of fluorescent nanodiamond particles (NV)-Z~800 (FNDP-(NV)) administered to rats by intravenous infusion in a single high dose.

methodsBroad scale biological variables were monitored following acute (90 minutes) and subacute (5 or 14 days) exposure to FNDP-(NV). Primary endpoints included morbidity and mortality, while secondary endpoints focused on hematology and clinical biochemistry biomarkers. Particle distribution (liver, spleen, lung, heart, and kidney) was assessed by whole organ near infrared imaging using an in vivo imaging system. This was validated by the quantification of particles extracted from the same organs and visualized by fluorescent and scanning electron microscopy. FNDP-(NV)-treated rats showed no change in morbidity or mortality and preserved normal motor and sensory function, as assessed by six different tests.

resultsBlood cell counts and plasma biochemistry remained normal. The particles were principally distributed in the liver and spleen. The liver particle load accounted for 51%, 24%, and 18% at 90 minutes, 5 days, and 14 days, respectively. A pilot study of particle clearance from blood indicated 50% clearance 33 minutes following the end of particle infusion.

conclusionWe concluded that systemic exposure of rats to a single high dose of FDNP-(NV)-Z~800 (60 mg/kg) appeared to be safe and well tolerated over at least 2 weeks. These data suggest that FNDP-(NV) should proceed to preclinical development in the near future.

Indexed as

Particle SizeAnimalsBiocompatible MaterialsBiomarkersBlood Cell CountBody WeightFluorescenceInfusions, IntravenousMaleNanodiamondsOrgan SizeOrgan SpecificityPilot ProjectsRats, Sprague-DawleySolubilityTissue DistributionBiocompatible MaterialsBiomarkersNanodiamondsbiocompatibilityfluorescent nanodiamond particlesnear infrared imagingneurobehavioral functionpharmacokineticsratscanning electron microscopy

Identifiers

PMID30271140
PMCPMC6149985

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.