A Pre-Cellular Therapy Observational Study in Early Huntington's Disease
PRE-CELL
PRE-CELL
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · CIRM
observational
29
1 country
1
Study Start
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2016
Actual (reported)Study Completion
July 2016
Actual (reported)This observational study will establish a clinical baseline and measure changes over time in movement, thinking, behavior, brain imaging, blood and spinal fluid markers in subjects with early stage Huntington's disease. Participants enrolled in this study may be eligible to participate in a future planned study of stem cell therapy for Huntington's Disease (HD). In-person study visits occur at screening, baseline, and every 6 months thereafter for a minimum of 12 months, with interim phone call assessments.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
August 26, 2013
Actual (reported)September 10, 2013
Actual (reported)July 2016
Actual (reported)July 2016
Actual (reported)Rate of change from baseline in white matter volume on magnetic resonance imaging (MRI) brain scan.
Baseline and 12 or 18 months
Rate of change from baseline on the UHDRS total motor score
Baseline and 12 or 18 months
Rate of change from baseline on the Total Functional Capacity score
Baseline and 12 or 18 months
Subjects will be primarily recruited from the Huntington's disease clinic in the University of California, Davis (UC Davis) department of neurology. We also plan to recruit participants from among northern California regional support groups, from letters to neurologists and psychiatrists who are treating patients with HD, from listing our study on clinical trials.gov, and at regional and national HD meeting presentations, and via print and video recordings on our website.
UC Davis Medical Center, Clinical Research Center
Sacramento, California, 95817, United States
Tempkin T, DeCarli C, Scher L, Farias S, Duffy A., Fink K, Annett G, Brunberg J, Yarborough M, Hersch S, Stout J, Alyward E, Martin A, Kjer L, Swadell D, Nolta J, Wheelock V. PRE-CELL: A Pre-Cellular Observational Study in Early Huntington's Disease. Eight Annual Huntington's disease Clinical Research Symposium, Minneapolis MN, November 2014; Neurotherapeutics 2015;12(1): 263-284
Wheelock V, Tempkin T, Duffy A, Martin A, Mooney L, Scher L, Farias S, Swadell D, DeCarli C, Brunberg J, Li C-S, Yarborough M, Dayananthan A, Stout J, Hersch S, Aylward E, Fink KD, Annett G and Nolta J. "PRE-CELL: Preparing for a future planned Phase 1 trial of genetically-modified stem cells over-expressing BDNF in patients with Huntington's disease." Ninth Annual Huntington's Disease Clinical Research Symposium (October 2015), Tampa FL
Moscovitch-Lopatin M, DiFiglia M, Kegel-Gleason K, Ritch JJ, Rosenthal SJ, Sapp E, Wheelock V, Duffy A, Chopra V, Rosas HD, Hersch SM. "A Novel Translational Bioassay for Conformers of Mutant Huntingtin." Ninth Annual Huntington's Disease Clinical Research Symposium (October 2015), Tampa FL
Safety labs: Complete blood count, comprehensive metabolic panel, international normalized ration, partial thromboplastic time, thyroid stimulating hormone, urinalysis, HIV screen. Biomarkers: Brain-derived neurotrophic factor (BDNF) in cerebrospinal fluid (CSF) and Plasma, BDNF related and Huntington's Disease (HD) specific gene transcription markers in CSF and blood, Small molecule markers of HD in CSF and plasma
Vicki Wheelock, MD
University of California, Davis
29 participants (actual enrollment reported by the registry).
First Submitted
August 26, 2013
First Posted
September 10, 2013
Study Start
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Tetrabenazine on Stroop Interference in HD
Contact the study team to confirm eligibility.
Primary Completion
July 2016
Actual (reported)Study Completion
July 2016
Actual (reported)Last Updated
November 1, 2016
Record last verified: 2016-10
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Source: ClinicalTrials.gov.
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