Neurology

Clinical trials for Neurology specialty

  • Sponsor: Private Foundation

    CSRC Protocol #: 117.15

    Enrollment: Currently enrolling

    Description:

    Dogs presenting with acute, concussive disk herniations share many similarities with human spinal cord injury patients. The prognosis for return to normal function is very guarded in dogs with acute onset of paraplegia and loss of pain perception in hind legs. The likelihood to regain ambulatory status is within the range of 43-69%. Fecal incontinence was observed in 41% and urinary incontinence in 32% of dogs regaining pain perception and ambulatory function. In dogs which fail to regain pain perception and ambulatory function after surgery, fecal and urinary incontinence will persist and frequent urinary tract infections are common. In addition, in some dogs this dysfunction can progress to the level of ascending urinary tract infection and sepsis.    New therapies are needed to improve these outcome.

    We propose to transplant allogeneic Wharton’s Jelly (umbilical cord matrix) mesenchymal stem cells (WJ-MSC) into the spinal cord of dogs admitted to the Foster Hospital at Cummings Veterinary Medical Center at Tufts University because of severe spinal cord injury secondary to intervertebral disc herniation/compression in order to study their potential as neuroprotective and regenerative agents.

    Our hypothesis is that chondrodystrophic dogs with an acute onset of paraplegia and loss of pain perception caudal to a thoracolumbar disk extrusion treated with decompressive surgery and subdural allogeneic WJ-MSC will have a significantly higher likelihood of a functional recovery than dogs treated with decompressive surgery alone.

    In this prospective study, paraplegic dogs with absent pain perception will be randomly assigned to WJ-MSC (in Cryostor) plus surgery or vehicle (Cryostor) plus surgery. Parameters of interest include time to return of pain perception, motor function, ambulation and urinary/fecal continence. A successful outcome will be defined as return to ambulatory function, normal pain perception caudal to the lesion and full urinary and fecal continence within 3 months post-surgery.

    A positive functional outcome as a result of stem cell transplantation would be a tremendous benefit and step forward for dogs being affected with concussive disk herniations. Determining such efficacy, along with an assessment of any related complications, would provide an ideal naturally occurring disease model in dogs could also be utilized in human therapeutics of spinal cord injury.

    Inclusion Criteria:

    Dogs of any age, sex weighing less than 25 kg with the following:

    ° Complete medical history

    ° Owner consent for inclusion into study

    ° Paraplegia with absent pain perception in hind legs and tail at admission

    ° Extradural compression between T3 – L3 diagnosed with CT or MRI

    ° Acute disk extrusion confirmed at surgery

    ° Follow up performed at Cummings School of Veterinary Medicine at Tufts University by neurology service

    Exclusion criteria:

    ° Unable to confirm disk extrusion intraoperatively

    ° Concurrent disease that could interfere with neurologic recovery

    ° Inability to obtain in-hospital follow-up performed at Tufts University by the neurology service

    ° No owner consent

    Client benefits:

    The study will cover all of the costs of stem cells treatment and follow-up appointments up to 3 months after the surgery, as well as contribute $1100 towards the cost of surgery. Your pet’s participation will also allow us to gain information which will help in the diagnosis/management/treatment of other dogs with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • Status:   Currently enrolling

    Description:

    Canine degenerative myelopathy (DM) is an inherited, progressive spinal cord disease, generally noticed after the age of 8 years.  Clinical signs are initially very mild and refer to a thoracolumbar spinal cord disease. Over time the clinical signs progress to lower motor neuron signs in the pelvic limbs, paraplegia, and later loss of motor function including in front legs with brainstem signs in the end stage.  Breed and also owner decision are important factors for survival since many dogs are euthanized when they can no longer walk.   The suspected diagnosis of degenerative myelopathy is established by exclusion of disorders causing similar signs such as chronic disk disease, spinal tumors , degenerative lumbosacral stenosis, hip dysplasia, chronic cruciate ligament disease or neuromuscular disorders.   Effective treatment options are not available.

    Many cases of canine degenerative myelopathy are caused by mutations in the gene encoding superoxide dismutase (SOD1). The purpose of the study is to determine whether a suppression of the activity of the mutant SOD1 gene can stop the progression of the clinical signs. In this study, the gene suppressing compound, is delivered to the spinal cord and brain using a small vector (known as adeno-associated vector or AAVrh10).

    Inclusion Criteria:

    1. Species: canine
    2. Sex: male, castrated male, female , spayed female
    3. Age Range: > 8 years
    4. Weight Range: > 20 kg
    5. Other:
    • Breeds: German shepherd, boxer, welsh corgi
    • History of chronic progressive hind end weakness
    • Ambulatory condition, neurological signs referring to a T3 - L3 localization
    • Only dogs without structural spinal cord lesions such as compressive intervertebral disk disease, spinal tumors, infectious or non-infectious meningomyelitis, malformations and degenerative lumbosacral stenosis will be included. The parameters should be within normal limits for CBC, chemistry profile, chest radiographs and MRI T3 - S1.
    • Only dogs without structural spinal cord disease and a homozygous SOD1 mutation will be enrolled into this study.
    • Signed consent form by owner including that dogs after adeno-associated vector treatment will undergo an autopsy with cremation of the body.

    Exclusion Criteria:

    1.  Dogs with structural spinal cord disease such as such as compressive intervertebral disk disease, spinal tumors, infectious or non-infectious meningomyelitis, malformations and degenerative lumbosacral stenosis will be excluded
    2. Dogs with active hepatitis will be excluded
    3. Dogs who are not homozygous for the SOD1 mutation will be excluded
    4.  We will exclude dogs for whom the owner does not sign a consent form.

    Client Benefits:

    The study will cover all the expenses related to the study and follow-up . This includes additional anesthesia procedures, additional MRI exam to inject the gene suppression compound, CSF analysis, vector treatment, recheck exams, force plate analysis, whole body EMG, motor test conduction of nerves, bloodwork, autopsy and cremation. The initial expenses such as initial neurological examination and intial MRI and anesthesia will not be covered by the study funds. Your pet's participation will also allow us to gain information which will help in the diagnosis and management and treatment of other dogs diagnosed with degenerative myelopathy, a disorder which is currently not treatable. You understand that your animal's participation in this study may not alleviate or cure his/her ailment.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu