title: A pilot study of recombinant insulin-like growth factor-1 in seven multiple sderosis patients.
abstract: The purpose of this open-label, crossover study was to determine the safety and efficacy of recombinant insulin-like growth factor-1 (rhIGF-1) using magnetic resonance imaging (MRI) and clinical measures of disease activity in seven multiple sderosis (MS) patients. Monthly clinical and MPI examinations were performed during a 24-week baseline and a 24-week treatment period with rhIGF-1. The primary outcome measure was contrast enhancing lesion (CEL) frequency on treatment compared to baseline. Secondary outcome measures included dinical and MRI measures of disease activity including: white matter lesion load (WMLL), magnetization transfer ratio (MTR), T1-Hypointensity volume, cervical spine cross-sectional area and proton magnetic resonance spectroscopic (MRS) imaging for determining regional metabolite ratios. rhIGF-1 (Cephalon) was administered at a dose of 50 mg subcutaneously twice a day for 6 months. rhIGF-1 was safe and well tolerated with no severe adverse reactions. There was no significant difference between baseline and treatment periods for any MRI or clinical measures of disease activity. Although rhIGF-1 did not alter the course of disease in this small cohort of MS patients, the drug was well tolerated. Further studies using rhIGF-1 alone or in combination with other therapies may be of value because of the proposed mechanism of action of this growth factor on the oligodendrocyte and remyelination.
authors.affiliation: Laboratory of Diagnostic Radiology Research, National Institutes of Health, Bethesda, Maryland 20892-1074, USA. jafrank@helix.nih.gov
authors.forename: J A
authors.initials: JA
authors.lastname: Frank
authors.forename: N
authors.initials: N
authors.lastname: Richert
authors.forename: B
authors.initials: B
authors.lastname: Lewis
authors.forename: C
authors.initials: C
authors.lastname: Bash
authors.forename: T
authors.initials: T
authors.lastname: Howard
authors.forename: R
authors.initials: R
authors.lastname: Civil
authors.forename: R
authors.initials: R
authors.lastname: Stone
authors.forename: J
authors.initials: J
authors.lastname: Eaton
authors.forename: H
authors.initials: H
authors.lastname: McFarland
authors.forename: T
authors.initials: T
authors.lastname: Leist
mesh_terms: D000368:Aged; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D010865:Pilot Projects; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D007334:Insulin-Like Growth Factor I