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

     

  • Sponsor: Private Foundation

    Status:  Currently Enrolling

    Description:

    Acute spinal cord injury affects thousands of people and numerous veterinary patients each year.  Intervertebral disc disease (IVDD) can cause movement of the disc that lives between the bones of the spine. This movement can press on the spinal cord and cause compression, resulting in a common cause of acute spinal cord injury in veterinary patients and leads to lack of function in the legs. This disease requires surgery to remove the disc that is compressing the spinal cord to try to reverse the loss of function in the legs. It can also cause bruising of the spinal cord or lack of blood flow, which cannot be reversed by surgery. Numerous studies have shown that the amount of function lost, most severely with the loss of sensation in the toes, is the best way to predict how a patient will recover after surgery with a 50% chance of recovery. However, why half of these patients recovery and the others don't recover or worsen is not clear at this time . Additionally, in disease processes where compression is not the main cause of injury and the bruising or lack of blood flow (ischemia) is the main cause of clinical signs, few studies have been conducted to determine prognosis. There are other diseases beside IVDD that can also lead to ischemia of the spinal cord and there is no treatment available to reverse these signs.

    An important goal of this study is to understand how chemicals called nucleic acids (RNA) are altered in canine patients after acute spinal cord injury. The study will focus on microRNA (miRNA), as these chemicals tell the body how to adapt after an injury or illness and can be targeted to help change the way our bodies respond through medications or therapies. They can also help aid our understanding of how humans and animals will recover from diseases. The specific objective of this study is to understand the quantity of specific miRNA, which are released into the cerebrospinal fluid (CSF, the fluid that lives around the brain and spinal cord) of canine patients after acute spinal cord injury (ASCI) versus non-ASCI patients undergoing sampling of the CSF for diagnosis of their disease.  Additionally, we aim to determine if plasma and CSF miRNA content differs within and between patient groups. .

    Client Benefits:

    The study will cover all the costs associated with the CSF tap, including the procedure and the fluid analysis.  The CSF will benefit the diagnosis and treatment of your dog by supplementing our workup and can help us determine the chances of recovery for your dog.  Your pet's participation will also allow us to gain information which may help in the diagnosis, management and treatment of other dogs with this condition in the future.  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