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U.S. Department of Health and Human Services

About FDA

Stress and Mitochondrial Toxicity

Description: Exploring mechanisms of free radical damage and toxicity to mitochondria as they relate to neurotoxicity/neurodegeneration. This study is supported by an interagency agreement between NIEHS/NTP and FDA to support studies of mutual benefit to FDA and NIEHS/ NIH.

Definition: Oxidative stress is caused by an imbalance in cells between reactive oxygen and their ability to detoxify reactive oxygen. This ability is related to aging and to several diseases. Mitochondrial toxicity occurs when the mitochondria of the body's cells become damaged or decline significantly in number. These conditions are studied here in relationship to neurotoxicity and neurodegeneration, both of which can cause loss of cognitive function.

These studies will provide insight into potential strategies for preventing or ameliorating the progression of neurodegenerative diseases.

Public Health Outcome: These studies will provide insight into potential strategies for preventing or alleviating the progression of neurodegenerative diseases which cause the progressive loss of structure or function of neurons.

1. Cell Phone Radiation Neurotoxicity

Briefing Status: DELAYED

Prior Briefing Status: DELAYED

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

a. Submit protocol to assess neurotoxicity associated with cell phone radiation

10/31/2009

Completed 12/31/2009

b. Start recruiting ORISE postdoc for cell phone radiation study

1/31/2010

Completed 1/20/2010

c. Onboard ORISE postdoc and begin work on cell phone radiation study

4/30/2010

Completed 3/15/2010

d. Present results at TSSRC

5/31/2010

Completed 5/18/2010

e. Generate data from cell phone radiation protocol in preparation for Toxicology Study Selection Review Meeting

9/30/2010

(12/31/2010)

Completed 11/17/2010

f. Complete assessment of research findings

5/30/2011

Completed 5/30/2011

g. Develop draft technical report/manuscript/publication on the effects on neurotoxicity association with cell phone radiation

6/30/2011

Completed 6/30/2011

h. Complete the peer review (NCTR and other FDA researchers) of draft technical report, manuscript, and/or publication

8/31/2011

(TBD)

Completed 12/31/2012

i. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system

9/30/2011

(3/15/2012)

(FY13 Q1)

(FY14 Q2)

(FY14 Q4)

Delayed

j. Submit final technical report, manuscript, and/or publication on neurotoxicity association with cell phone radiation to a scientific journal/NTP

11/1/2011

(4/15/2012)

(FY13 Q1)

(FY14 Q2)

(FY14 Q4)

Delayed

Footnotes

  • The dates in italics are modified milestone due dates that have been updated due to real-time delays. The milestone status reflects the current reporting quarter’s status. If a milestone is missed, the milestone will remain delayed until the milestone is completed.

2. Oxidative Stress Projects

Accomplishment: Major findings from this research identified possible neuroprotective roles for carnitine compounds for 3-NPA-induced hypothermia and neuronal degeneration and resveratrol for 3-NPA evoked peripheral neuropathy.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

a. Submit concept paper on oxidative stress, neurodegeneration and imaging biomarkers

11/30/2009

Completed 3/3/2010

b. Submit concept paper on oxidative stress, nanoparticles and MRI

2/28/2010

Completed 3/15/2010

c. Submit manuscript on oxidative stress, nanoparticles, and MRI

6/30/2010

Completed 6/15/2010

d. Submit additional manuscript on oxidative stress, nanoparticles, and blood brain barrier to a scientific journal

7/31/2010

Completed 8/25/2010

3. Silver Nanoparticles Study

Accomplishment: Silver nanoparticles were shown to decrease body weight and locomotor activity. In order to gain a better understanding of the nanoparticles, various detection methods were utilized. This study is one of the first known experiments to determine toxicity of silver nanoparticles in mammals.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

a. Receive and install microscope for cell culture lab

12/31/2009

Completed 12/14/2009

b. Begin use of the confocal microscope in support of silver nanoparticles study

3/31/2010

Completed 3/8/2010

c. Review results obtained using the confocal microscope in support of silver nanoparticles study

6/30/2010

(8/30/2010)

(12/1/2010)

(2/28/2011)

Completed 2/28/2011

d. Complete assessment research findings

12/31/2010

(2/28/2011)

Completed 2/28/2011

e. Submit abstract on findings to Scientific meeting

12/31/2010

(2/28/2011)

Completed 3/23/2011

f. Develop draft technical report/manuscript/publication on the silver nanoparticles study results

2/1/2011

Completed 3/1/2011

g. Complete the peer review (NCTR and other FDA researchers) of draft technical report, manuscript, and/or publication

4/1/2011

Completed 4/1/2011

h. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system

5/1/2011

Completed 5/1/2011

i. Submit final technical report, manuscript, and/or publication on the silver nanoparticles study results to a scientific journal/NTP

7/1/2011

Completed 8/15/2011

j. Submit additional manuscript on the research results of this Silver Nanoparticles Study to a scientific journal.

3/1/2012

(FY13 Q2)

Completed 7/31/2013

Footnotes

  • The dates in italics under the milestone due dates are modified milestone due dates which had to be updated due to real-time delays. The milestone status reflects the revised dates.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

mitochondria

cellular energy sources

NIEHS

National Institute of Environmental Health Sciences

NTP

National Toxicology Program

NIH

National Institutes for Health

ORISE

Oak Ridge Institute for Science and Education

TSSRC

Toxicology Study Selection Review Committee

carnitine compounds

present in muscle and liver and involved in the transport of fatty acids across mitochondrial membranes

neuronal degeneration

progressive loss of structure or function of neurons

resveratrol

a natural compound found in grapes, mulberries, peanuts, and other plants or food products, especially red wine, that may protect against cancer and cardiovascular disease by acting as an antioxidant, antimutagen, and anti-inflammatory

neuropathy

nerve damage

concept paper

description of a planned research activity that is submitted to the NCTR Director in advance of submission of a protocol

biomarkers

measurable characteristics that indicate the transition between biological states such as healthy or diseased

MRI

Magnetic Resonance Imaging

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.