19 Harley St, London, W1G 9QJ, UK

A phase I/IIa clinical trial of a recombinant Rho protein antagonist in acute spinal cord injury

Multiple lines of evidence have validated the Rho pathway as important in controlling the neuronal response to growth inhibitory proteins after central nervous system (CNS) injury. A drug called BA-210 (trademarked as Cethrin((R))) blocks activation of Rho and has shown promise in pre-clinical animal studies in being used to treat spinal cord injury (SCI). This is a report of a Phase I/IIa clinical study designed to test the safety and tolerability of the drug, and the neurological status of patients following the administration of a single dose of BA-210 applied during surgery following acute SCI. Patients with thoracic (T2-T12) or cervical (C4-T1) SCI were sequentially recruited for this dose-ranging (0.3 mg to 9 mg Cethrin), multi-center study of 48 patients with complete American Spinal Injury Association assessment (ASIA) A. Vital signs; clinical laboratory tests; computed tomography (CT) scans of the spine, head, and abdomen; magnetic resonance imaging (MRI) of the spine, and ASIA assessment were performed in the pre-study period and in follow-up periods out to 1 year after treatment. The treatment-emergent adverse events that were reported were typical for a population of acute SCI patients, and no serious adverse events were attributed to the drug. The pharmacokinetic analysis showed low levels of systemic exposure to the drug, and there was high inter-patient variability. Changes in ASIA motor scores from baseline were low across all dose groups in thoracic patients (1.8+/-5.1) and larger in cervical patients (18.6+/-19.3). The largest change in motor score was observed in the cervical patients treated with 3 mg of Cethrin in whom a 27.3+/-13.3 point improvement in ASIA motor score at 12 months was observed. Approximately 6% of thoracic patients converted from ASIA A to ASIA C or D compared to 31% of cervical patients and 66% for the 3-mg cervical cohort. Although the patient numbers are small, the observed motor recovery in this open-label trial suggests that BA-210 may increase neurological recovery after complete SCI. Further clinical trials with Cethrin in SCI patients are planned, to establish evidence of efficacy

Keywords : Abdomen,ADP Ribose Transferases,Adult,analysis,antagonists & inhibitors,Botulinum Toxins,Canada,Central Nervous System,drug therapy,Enzyme Inhibitors,Female,Growth,Head,Humans,injuries,Laboratories,Magnetic Resonance Imaging,Male,Nervous System,Neuroprotective Agents,Neurosurgery,Ontario,Patients,pharmacokinetics,Recombinant Proteins,Recovery of Function,rho-Associated Kinases,Safety,Spinal Cord,Spinal Cord Injuries,Spinal Injuries,Spine,surgery,therapeutic use,Universities,, Phase,I/Iia,Clinical,Trial, fibro elbow pain

Date of Publication : 2011 May

Authors : Fehlings MG;Theodore N;Harrop J;Maurais G;Kuntz C;Shaffrey CI;Kwon BK;Chapman J;Yee A;Tighe A;McKerracher L;

Organisation : Department of Neurosurgery, University of Toronto, Toronto, Ontario, Canada. michael.fehlings@uhn.on.ca

Journal of Publication : J Neurotrauma

Pubmed Link : https://www.ncbi.nlm.nih.gov/pubmed/21381984

The London Spine Unit : Harley Street UK. Specialists in Cutting Edge Technologies for Spinal Surgery

Make an Appointment 

Trustpilot Reviews
Doctify Reviews
Top Doctor Reviews

A phase I/IIa clinical trial of a recombinant Rho protein antagonist in acute spinal cord injury | Pdflumbar spine fusion/disc replacement - nottingham university

What our patients say ...

Consultant Spine Surgeon
Consultant Spine Surgeon
Consultant Spine Surgeon

This surgical technique consists of a percutaneous approach for the treatment of small to medium size hernias of the intervertebral disc by laser energy. The main objective is to reduce the intradiscal pressure in the nucleus pulposus

Laser Disc Surgery can be performed under local anaesthetic as a day case at our centre on the prestigious Harley Street.
What is London spine unit and How it Works

The London Spine Unit was established in 2005 and has successfully treated over 5000 patients. All conditions are treated.

treatment of all spinal disorders

The London Spine Unit specialises in Minimally Invasive Treatments allowing rapid recovery and return to normal function

Trusted by patients worldwide

The London Spine Unit provides the highest quality care to all patients and has VIP services for those seeking exceptional services

If you have any emergency Doctor’s need, simply call our 24 hour emergency

Your personal case manager will ensure that you receive the best possible care.

Call Now 

+44 844 589 2020
+44 203 973 8810