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Chondroitinase Clinical Trial

Chondroitinase Clinical Trial
for dogs with severe spinal cord injury

 

 

 

Links:

   

 

 

Trial Summary

 

Start: Now

Participation: 6 Months 

Duration: 3 Years 

Species: Canine 

Condition: Spinal cord injuries 

Treatment: Chondroitinase

Contacts:
Dr. Nick Jeffery 
(515) 294–4900 
njeffery@iastate.edu

 
Dr. Hilary Hu 
(515) 460–2937
hilaryhu@iastate.edu

 

Location:
Iowa State University 

Lloyd Veterinary Medical Center
 

Cost: $100 

Benefits:
Rehab Therapy Hospitalization

 
 
 

"Spinal cord injuries can lead to serious consequences including the impairment of movement, sensation and urination; this is because spinal cord tissue does not regenerate effectively"

Background

 

Spinal cord injuries are one of the most commonly presented neurological conditions in veterinary medicine. They can have devastating impacts on the animals and their families as they can lead to loss of movement, sensation and urination. This is largely because the spinal cord tissue does not regenerate effectively.

Following spinal cord injury, nerve cells on the two sides of the injured area are not able to properly communicate with each other. This means that the brain is not able to tell the legs what to do and the legs are not able to tell the brain where they are and what they are doing. The same problem happens with the bladder and bowels too. This means that affected dogs may be unable to walk and they may also become incontinent.

The purpose of our clinical trial is to help these severely affected dogs by testing if a new treatment, called chondroitinase, may improve the outcome after spinal cord injury in dogs.

 
 
Running on the treadmill  
 
 

"Chondroitinase improves the outcome after spinal cord injuries in lab animals; therefore it could also benefit dogs and people suffering from the same conditions."

Why Chondroitinase?

During the past decade, numerous experiments in laboratory rodents have shown the benefits of injecting chondroitinase into regions of damaged spinal cord. The drug works by dissolving away some of the scarring tissue that forms after spinal cord injury, allowing new nerve fibers to grow across the damaged region and restore communication. Successful intervention using chondroitinase in laboratory animals has been especially notable when it has been combined with physical therapy.

During our trial, we will inject chondroitinase into the spinal cord and then perform various tests over the following 6 months to assess changes in gait and control of the bladder. The results will then be compared with those from dogs that have not had the condroitinase injection, so that we can determine if the treatment is effective. Fortunately, there have been no reports of damaging effects of this treatment; and the safety trial that we previously conducted here in dogs with spinal cord injury also suggested this treatment is very safe.

 

 
 

Is my dog eligible?

Any dogs with severe injury to the spinal cord in the middle of the back are eligible, so long as they also:

 

  • Weigh less than 20kg (approx. 45lb)
  • Have not recovered the ability to walk unaided by at least 6 weeks after injury
  • Do not have another medical condition that would interfere with treatment and assessment
  • Will not become distressed by being in a hospital
  • Have owner consent to undergo treatment
 
 

What happens during the trial?

Dogs that are entered into the trial will have some 'baseline' assessments made of their limb coordination and bladder control. They will then be randomized to receive either the test therapy (chondroitinase) followed by physical therapy, or to receive physical therapy alone. This means that each dog in the trial will have a 50% chance of getting the test medication at the start of the trial—but ALL dogs will receive free physical therapy as part of the trial.

Dogs in both groups will be anesthetized and have special x-rays taken to check the site of the injury; dogs in the treatment group will have the injection during this period of anesthesia. Dogs will then be invited to stay at our hospital facility for one week so that they can receive physical therapy to encourage their ability to walk. They will then go home with instructions about how best to encourage their mobility and toilet training.

All dogs will return to our hospital at 1 month, 3 months and 6 months after the initial visit for repeat clinical assessment and a free week-long course of physical therapy. For owners that are able to return more frequently, we will offer weeklong physical therapy sessions once each month for six months.

At the end of the trial period we will let you know what group your dog was in and offer the option of chondroitinase injection to those who didn't receive it previously.

Placing Markers for Gait Analysis

 

Physical Therapy with the Underwater Treadmill

 
 
 

 

What will it cost?

The study has a charity sponsor (see below) and so charges made to the owners are minimal. A single fee of $100 to enter the trial is made to cover hospital administrative costs. All trial treatments, including up to 6 weeks of physical rehabilitation therapy, will be free of charge to owners.

 
 

Our sponsor

This trial is being sponsored by the International Spinal Research Trust (IRST), a charity that searches for treatments for humans that have suffered spinal cord injury. This study is of interest to the ISRT because if dogs were shown to benefit from this treatment then it would provide strong evidence that it would be a good idea to test in human patients. Human trials are very costly and spinal cord injury is much more common in dogs than in people, meaning that it is sensible for us to test this intervention in dogs first. It also means that, if the treatment is successful, dog patients will be the first to benefit from this new approach to spinal cord injury!

 

 

 

 

 

 

 

 

 

 

 

 

Dr. Jeffery performing sensory tests on clinical trial patient

 

Contact us

 

Dr. Nick Jeffery | 515-294-4900 | njeffery@iastate.edu

 

Dr. Hilary Hu | 515–460–2937 | hilaryhu@iastate.edu

 

Iowa State University Veterinary Medical Center | vetmed.iastate.edu/vmc