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11. Title: A Phase I/IIa Dose-Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BA-210 and the Neurological Status of Patients Following Administration of a Single Extradural Application of Cethrin® During Surgery for Acute Thoracic and Cervical Spinal Cord Injury.

Purpose: The primary goal of this study is to determine the safety and tolerability of BA-210 when administered in conjunction with fibrin sealant to the dura mater of the spinal cord during surgery. A second goal is to determine if BA-210 improves neurological function.

Principal Investigator: James S. Harrop, MD
Co-Investigator(s): Ashwini D. Sharan, MD, Alexander R. Vaccaro, MD, Ralph J. Marino, MD

Background: Spinal cord injury occurs in an instant and can transform an individual into a person who must live with a permanent disability, without autonomy, and with severe co-morbidities. Following spinal cord injury, there is an abnormal activation of the intracellular signaling protein Rho, which causes cell death.

We are currently conducting a clinical trial to investigate the potential of a new therapy, BA-210 (Cethrin®), in acute spinal cord injury. BA-210 is a recombinant protein drug, which acts as a Rho antagonist to promote neuroregeneration and neuroprotection in the Central Nervous System (CNS). We have shown in animal studies that BA-210 reduces the damage from spinal cord injury and stimulates axon regeneration when applied to the spinal cord. Further, BA-210 applied to the dura mater can penetrate into CNS tissue. In this clinical trial, BA-210 will be applied to the surface of the dura mater of the spinal cord together with Tisseel®, a fibrin sealant normally used to repair small dural tears.

This is a first in man study which involves a single application of BA-210, during surgery within 7 days following spinal cord injury. Male or female patients aged between 16 and 70 years with acute thoracic or cervical spinal cord injury (with no motor or sensory function in the sacral segment) can be enrolled.

Status: Enrolling

Criteria for enrollment: Male or female, aged 16-70 years. The first group of subjects enrolled must have a complete thoracic (T2-T12) spinal cord injury and be scheduled to undergo spinal surgery within 7 days of injury. The second group of subjects must have acute cervical complete (C4-T1) spinal cord injury and be scheduled to undergo spinal surgery within 7 days of injury.