Norbert Weidner, Heidelberg University Hospital, Heidelberg, Germany

NISCI-Study: Antibodies against Nogo-A to enhance regeneration and functional recovery after acute spinal cord injury - a multicenter European clinical proof of concept trial

Funded in: 2019, 2020, 2021, 2022, 2023


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Problem: Protein Nogo-A inhibits regeneration of damaged nerve fibres

Target: Antibodies against Nogo-A to enhance regeneration and functional recovery after acute spinal cord injury

Goal: Implementing a multicenter European clinical proof of concept trial

This clinical trial examines a new treatment method for acute traumatic spinal cord injury. The damage interrupts nerve fibres in the spinal cord and the transmission of electric nerve impulses, from the brain to certain body parts, is impaired. Depending on the localization, type and severity of the injury, there can be a loss of function such as movement, sensation, failure of bladder control etc. Subsequent to an injury of the nervous system, a certain protein, Nogo-A, is produced, which inhibits regeneration of damaged nerve-fibres. This protein blocks an important step to regain nerve function. In this clinical trial, an antibody (NG-101) is made available that inhibits the protein Nogo-A, stopping it from suppressing nerve growth.

 


This might be a step towards repairing a recent spine damage. The spine is located in a canal, protected by vertebrae and connective tissue (spinal canal). The spinal cord, a part of the central nervous system, is (similar to the brain) surrounded by cerebrospinal fluid. During the course of this clinical trial, an antibody (NG-101) will be applied directly into the cerebrospinal fluid. We expect from the clinical trial an improved recovery of damaged nerve fibres with subsequent improvement of motor and sensory function and improved activities of daily living. Furthermore, a reduction in caregiver support by regaining sensation and mobility is aimed for. In Germany and Switzerland 52 patients were enrolled in a previous trial. A good tolerance of the study medication was observed in this earlier trial. This trial examines proof of the working principle and safety data (adverse reactions). The dose and method of administration used in this trial has been shown to be well tolerated in 15 patients so far. Eligible for participation in this trial are patients with an acute spine injury (up to 28 days following damaging event) with complete (no function below the damaged spinal cord) or incomplete (some remaining function below the injury site) functional impairment.