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Safety and tolerabi...
Safety and tolerability of intracerebroventricular PDGF-BB in Parkinson's disease patients
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- Paul-Visse, Gesine (författare)
- Lund University,Lunds universitet,Neurologi, Lund,Sektion IV,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Neurology, Lund,Section IV,Department of Clinical Sciences, Lund,Faculty of Medicine
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Zachrisson, Olaf (författare)
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- Varrone, Andrea (författare)
- Karolinska Institutet
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- Almqvist, Per (författare)
- Karolinska Institutet
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Jerling, Markus (författare)
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- Lind, Goran (författare)
- Karolinska Institutet
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Rehncrona, Stig (författare)
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- Linderoth, Bengt (författare)
- Karolinska Institutet
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- Bjartmarz, Hjalmar (författare)
- Lund University,Lunds universitet,Neurokirurgi,Sektion IV,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Neurosurgery,Section IV,Department of Clinical Sciences, Lund,Faculty of Medicine
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Shafer, Lisa L. (författare)
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Coffey, Robert (författare)
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- Svensson, Mikael (författare)
- Karolinska Institutet
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Mercer, Katarina Jansson (författare)
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- Forsberg, Anton (författare)
- Karolinska Institutet
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- Halldin, Christer (författare)
- Karolinska Institutet
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- Svenningsson, Per (författare)
- Karolinska Institutet
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Widner, Hakan (författare)
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- Frisen, Jonas (författare)
- Karolinska Institutet
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- Palhagen, Sven (författare)
- Karolinska Institutet
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Haegerstrand, Anders (författare)
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(creator_code:org_t)
- 2015
- 2015
- Engelska.
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Ingår i: Journal of Clinical Investigation. - 0021-9738 .- 1558-8238. ; 125:3, s. 1339-1346
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http://dx.doi.org/10...
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Abstract
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- BACKGROUND. Recombinant human PDGF-BB (rhPDGF-BB) reduces Parkinsonian symptoms and increases dopamine transporter (DAT) binding in several animal models of Parkinson's disease (PD). Effects of rhPDGF-BB are the result of proliferation of ventricular wall progenitor cells and reversed by blocking mitosis. Based on these restorative effects, we assessed the safety and tolerability of intracerebroventricular (i.c.v.) rhPDGF-BB administration in individuals with PD. METHODS. We conducted a double-blind, randomized, placebo-controlled phase I/IIa study at two clinical centers in Sweden. Twelve patients with moderate PD received rhPDGF-BB via an implanted drug infusion pump and an investigational i.c.v. catheter. Patients were assigned to a dose cohort (0.2, 1.5, or 5 mu g rhPDGF-BB per day) and then randomized to active treatment or placebo (3:1) for a 12-day treatment period. The primary objective was to assess safety and tolerability of i.c.v.-delivered rhPDGF-BB. Secondary outcome assessments included several clinical rating scales and changes in DAT binding. The follow-up period was 85 days. RESULTS. All patients completed the study. There were no unresolved adverse events. Serious adverse events occurred in three patients; however, these were unrelated to rhPDGF-BB administration. Secondary outcome parameters did not show dose-dependent changes in clinical rating scales, but there was a positive effect on DAT binding in the right putamen. CONCLUSION. At all doses tested, i.c.v. administration of rhPDGF-BB was well tolerated. Results support further clinical development of rhPDGF-BB for patients with PD.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
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Paul-Visse, Gesi ...
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Zachrisson, Olaf
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Varrone, Andrea
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Almqvist, Per
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Jerling, Markus
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Lind, Goran
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visa fler...
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Rehncrona, Stig
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Linderoth, Bengt
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Bjartmarz, Hjalm ...
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Shafer, Lisa L.
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Coffey, Robert
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Svensson, Mikael
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Mercer, Katarina ...
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Forsberg, Anton
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Halldin, Christe ...
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Svenningsson, Pe ...
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Widner, Hakan
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Frisen, Jonas
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Palhagen, Sven
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Haegerstrand, An ...
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Lunds universitet
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Karolinska Institutet