CHONDROITINASE (CH’ASE) CLINICAL TRIAL FOR DOGS: FIRST RESULTS

Researcher’s view – By Dr Thanos Didangelos – Kings College, London. – Dec 2016

One of the key pathological features of spinal cord injury is the accumulation of large quantities of scar tissue (glial scar) within the injury epicentre. The scar blocks neurons from crossing through the injury site and prevents them from transmitting movement and sensory information to the limbs. One promising therapeutic strategy is to remove the molecules that make up the scar using an enzyme called chondroitinase, naturally produced by bacteria. Chondroitinase was shown to be extremely effective in rats 15 years ago but unfortunately it has not been clinically tested in larger animals or humans yet. The current study by the Iowa State University, which awaits to be published in the scientific literature, is the first to try clinical-grade chondroitinase therapy in a large number (60) of dogs which get spinal injuries similar to humans. Chondroitinase treatment was safe and did not cause any side-effects. 10% of treated injured dogs showed improved walking after one month of treatment and their bladder function also improved. Although the number of dogs with improvement is small (10%), the study is promising and suggests that better results might be achieved in the future by altering the dosage and the delivery of the drug into the spinal cord. Chondroitinase therapy got its first clinical trial in real-life spinal cord injured dogs.

Patient’s view – By Corinne Jeanmaire – endParalysis foundation

We, humans, are not the only creatures afflicted with devastating spinal cord injuries.  As a matter of fact dogs can also become the sad victims of paralysis as the consequence of an accident or a physiological defect/disease.  The Chondroitinase Therapy has already proven effective on rats.  One of the following stages in the experiment, before this therapy can be tested on humans, is the performance after tests carried out on canines.  The dog trial was part of the Chase-It project initiated by our partner Spinal Research in the UK and was designed to assess the safety and efficacy of a direct injection of the Chondroitinase enzyme on a chronically injured spinal cord.  The article below confirms that the therapy is safe.  The results however, even though positive, are not decisive enough.  This might mean that an indirect administration of the enzyme is necessary, e.g. through a viral vector which is also currently being tested within the Chase-It program, or that some of the parameters of the therapy have to be adjusted to achieve better results.

Scientific data: By the Iowa State University of Vet Medicine

Hello Clinical Trial Friends and Families!
We have now officially completed the clinical trial and the key points are: (1) chondroitinase ABC has no detectable side effects in our 60 patients, meaning that it is a relatively safe drug based on our observations; (2) while a group effect is not detectable, there is evidence suggestive of some potential treatment effect in a subset of patients (e.g. 10% of the Treatment group patients regained ambulation after one month and the bladder test result also improved in Treatment group after one month); (3) future research should probably focus on adjusting the drug dosage, means of delivery and patient selection (e.g. choosing patients that are more likely to benefit from the treatment, such as those that already have some function in their back legs).

The study will be written up and submitted to a medical/scientific journal by early next year. The reviewing process may take a while but we will keep you posted!

Thank you so much for your participation and support!
Clinical Trial Team

STUDY ABSTRACT:
Traumatic spinal cord injury is a devastating neurologic condition in both veterinary and human medicine and despite research yielding numerous potential interventions with remarkable efficacy demonstrated in rodent models, none has advanced to successful clinical translation. Pet dogs’ predilection for sustaining spinal cord injury, typically due to intervertebral disc herniation or vertebral column fracture, makes them a suitable clinical model in which putative interventions for spinal cord injury can be tested […]

[Picture credits: Dog clinical trial team.