EPO is being trialled for neuro-protection. This small study shows promise.
Exploring recombinant human erythropoietin in chronic progressive multiple sclerosis 30 August 2007
The neurodegenerative aspects of chronic progressive multiple sclerosis (MS) have received increasing attention in recent years, since anti-inflammatory and immunosuppressive treatment strategies have largely failed. However, successful neuroprotection and/or neuroregeneration in MS have not been demonstrated yet. Encouraged by the multifaceted neuroprotective effects of recombinant human erythropoietin (rhEPO) in experimental models, we performed an investigator-driven, exploratory open label study (phase I/IIa) in patients with chronic progressive MS. Main study objectives were (i) evaluating safety of long-term high-dose intravenous rhEPO treatment in MS, and (ii) collecting first evidence of potential efficacy on clinical outcome parameters.
Eight MS patients, five randomly assigned to high-dose (48 000 IU), three to low-dose (8000 IU) rhEPO treatment, and, as disease controls, two drug-naïve Parkinson patients (receiving 48 000 IU) were followed over up to 48 weeks: A 6-week lead-in phase, a 12-week treatment phase with weekly EPO, another 12-week treatment phase with bi-weekly EPO, and a 24-week post-treatment phase. Clinical and electrophysiological improvement of motor function, reflected by a reduction in expanded disability status scale (EDSS), and of cognitive performance was found upon high-dose EPO treatment in MS patients, persisting for three to six months after cessation of EPO application. In contrast, low-dose EPO MS patients and drug-naïve Parkinson patients did not improve in any of the parameters tested. There were no adverse events, no safety concerns and a surprisingly low need of blood-lettings.
This first pilot study demonstrates the necessity and feasibility of controlled trials using high-dose rhEPO in chronic progressive MS.
Hannelore Ehrenreich1, Benjamin Fischer1, Christine Norra1, Felix Schellenberger1, Nike Stender1, Michael Stiefel2, Anna-Leena Sirén1, Walter Paulus3, Klaus-Armin Nave1,4, Ralf Gold4 and Claudia Bartels1
1Max Planck Institute of Experimental Medicine, Departments of 2Radiology and 3Clinical Neurophysiology, Georg-August-University and 4Hertie Institute of Multiple Sclerosis Research, Göttingen, Germany
Source: Brain Copyright © 2007 Guarantors of Brain (30/08/07)