Transverse Myelitis Association
Volume 6 Issue 1

Page 5

The use of erythropoietin in the treatment of acute transverse myelitis
Principal Investigator: Sanjay C. Keswani, MBBS/MRCP
Co-investigators: Douglas A. Kerr, MD PhD; Peter A. Calabresi, MD; Craig Jones, PhD; Chitra Krishnan, MHS; Susumu Mori, PhD

Transverse Myelitis (TM) is a focal inflammatory disorder of the spinal cord, with potentially devastating consequences. Two-thirds of patients are left permanently disabled after TM, being confined to the wheel chair or bed due to limb weakness. Although inflammatory demyelination is the predominant pathological finding in TM, secondary axonal injury and neuronal loss is likely to be more relevant to the development of permanent disability, similar to what has been reported for multiple sclerosis. This study aims to investigate the efficacy of a promising neuroprotective agent, erythropoietin, in the treatment of patients with TM.

Erythropoietin has been shown in numerous animal studies to protect neurons in the central nervous system from injury by a variety of insults, including hypoxia, free radicals and glutamate excitotoxicity, through activation of NF- κ B – mediated survival pathways. Of pertinence to this proposal, erythropoietin counteracts secondary injury and markedly enhances neurological recovery from experimental spinal cord trauma, and prevents motor neuron apoptosis and neurological disability in experimental spinal cord ischemic injury.

We propose a prospective, randomized, double-blinded, placebo-controlled six month follow-up pilot study in 30 subjects between the ages of 18 and 70 with newly-diagnosed TM. Patients who consent to enter the study will be randomized to be given either a subcutaneous dose of 40,000 U of PROCRIT (recombinant human erythropoietin) or placebo. They will receive this therapy within 2 weeks of neurological symptom onset. This will be followed by another dose of 40,000 U of PROCRIT or placebo two weeks later. All patients will receive a 5 day course of high dose steroids (1g IV solumedrol qd) which is presently the standard of care, followed by a steroid taper.

The primary aim of this study is to obtain preliminary data on the safety and tolerability of PROCRIT in patients with TM. Secondary outcome measures are changes in neurological function as measured by the Expanded Disability Status Scale (EDSS) and MSFC between months 1 and 6; and assessment of spinal cord axonal loss as measured by Magnetic Resonance Imaging (conventional, DTI and MTw). As recombinant human erythropoietin (rhEPO) has been used for decades to treat the anemia of patients with chronic renal disease and hematological malignancy, and is known to be safe with few side effects, it is expected that rhEPO will also be safe in our patient population. Data generated from this pilot study will be used to determine if a larger, phase III clinical trial is warranted.

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