Regenerative Medicine / Stem Cell Trials

Clinical trials for the specialty

  • Sponsor: Private Foundation

    IACUC protocol#: G2015-58                                                                                                                                 Status:  Currently enrolling

    Description:

    The goal of this study is to compare plasma biomarkers in the form of extracellular RNA in dogs with mitral valve disease presenting with versus without congestive heart failure.

    This study will be an important step towards making exosome analysis a useful and readily available tool for evaluating the progression, the molecular basis for remodeling, and development of specific therapies for mitral valve disease.

    Inclusion/exclusion criteria:

    All dogs should be over eight years of age in order to control for age related differences.

    Healthy: for controls the dogs will be defined as a healthy animal with a normal physical exam, normal CBC/chemistry panel/UA and no evidence of a heart murmur as documented by a veterinarian

    There will be four populations that will be included in this study:

    • Group 1: Healthy dogs with no cardiac disease
    • Group 2: Dogs with mitral valve disease not in congestive heart failure.
    • Group 3: Dogs with mitral valve disease in congestive heart failure.

    Contact Information:

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

     

  • Status:  Currently enrolling

    Description:

    The success of cardiopulmonary resuscitation (CPR) is very low, in veterinary (as well as human) patients. Even after successful return to spontaneous circulation, sequela to CPR include repeated cardiac arrest, brain disease, and multi-organ system failure. Low oxygen levels to the brain is the major factor contributing to these poor outcomes. There is a critical gap in our understanding of the physiology and prognosis after CPR, which has led to failure to substantially improve our success in dealing with this problem.

    An important goal of this study is to understand how chemicals called nucleic acids (RNA) are altered in post-CPR canine patients. The study will focus on very small RNA (miRNA). The specific objective of this study is to understand which miRNA are released into the circulation of canine patients after cardiopulmonary resuscitation (CPR) versus non-CPR patients hospitalized in the ICU for other reasons.

    There is tremendous potential value in identifying circulating miRNA after CPR. First, miRNA may assist in predicting outcome (prognosticating) in individual patients in the future. Second, miRNAreleased into the circulation are indicators of major epigenetic disturbances as a consequence of hypoxia-ischemia.    Knowledge of these miRNA may lead to the design of novel therapies to counteract these effects, for example employing stem cells that release mitigating miRNA.

    Inclusion Criteria:

    Group 1:  Six dogs that have undergone CPR according to standard protocols in the TCSVM emergency room and have returned to spontaneous circulation for a minimum of 1 hr.

    Group 2:  Six dogs hospitalized in the ICU that have not experienced CPR or significant hypoxemia or ischemia (e.g. GDV, hemorrhage, stroke) will be selected for sampling at the same time (AM vs. PM). Dogs will be similar age and gender as post-CPR patient.

    Any breed is acceptable.

    Exclusion Criteria:

    • Dogs < 10 kg
    • Dogs with prior hypoxemia insult (prior arrest or CPR, GDV, stroke, hemorrhagic shock, congestive heart failure, etc).
    • Dogs with a diagnosis of cancer
    • Dogs with hemolytic disease
    • Dogs for which blood sampling is contraindicated (recent fluid/colloid resuscitation)

     

    Client Benefits:

    The study will cover the cost of a blood panel (NOVA) at the same time the sample is being collected; this is testing that is normally performed every few hours during recovery from CPR, it is also testing that is normally performed in sick dogs. Your pet’s participation will also allow us to gain information which will help in the 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

    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:

    The goal of this study is to measure the presence of a blood marker, miRNA, in dogs with naturally occurring bone cancer (osteosarcoma) and compare these results to healthy unaffected dogs. We hypothesize that the presence of this biomarker will positively correlate with the presence of tumor and high expression levels may be associated with outcomes of disease-free interval and survival time in dogs with osteosarcoma.  Approximately 10 mls (2 teaspoons) of blood will be collected from your dog’s vein via routine blood sampling. Blood collection ideally will occur both prior to and following removal of your dog’s tumor. This is a safe amount of blood that can be sampled in any dog greater than 5 kilograms.

    Inclusion Criteria:

    Dogs with osteosarcoma weighing 5 kilograms (11 pounds) or greater

    Client Benefits:

    Your pet’s participation will 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

     

     

  • CSRC protocol # 115.16

    Status: Currently enrolling

    Description:

    The goal of this study is determine if a human stem cell-based therapy can be used to treat perianal fistulas, a condition that occurs in dogs but also occurs in some humans suffering from Crohn’s Disease. The current treatments (steroids and cyclosporine) are ineffective in a high percentage of patients and the disease relapses frequently. Also, cyclosporine is very expensive and has many side effects. We want to investigate if human stem cells (hESC-MSCs) injected in the fistulas can induce remission of the diseaseSpecifically, we would like to determine if a second injection of hESC-MSCs can close any fistulas that may re-appear after the initial closure of fistulas (ie, if the effects of the first injection wear off). The hESC-MSC can have some advantage compared with autologous stem cells, for instance, namely: (1) ease of use (no need to extract bone marrow, high numbers easily generated in the lab); (2) well defined and constant property (no variability) (3) higher anti-inflammatory properties. The trial is therefore of high interest not only for this specific disease but also for other diseases that may benefit from treatment with hESC-MSCs in humans.

    This trial is also being conducted at Massachusetts Veterinary Referral Hospital in Woburn, MA

    Inclusion Criteria:

    Adult dogs (either gender, any breed) with a clinical diagnosis of anal fistulas (presence of chronic peri-anal fistula(s) with clinical signs of tenesmus, dyschezia) and present with partial or complete relapse from cyclosporine A therapy.

    Exclusion Criteria:

    Dogs younger than 1 year or older than 12 years will be excluded; dogs with other severe diseases (severe osteoarthritis, cardiac disease, neoplasia, skin diseases) apart from anal furunculosis will be excluded. Dogs that had surgery (cryosurgery, anal sac resection, tail amputation) to treat the anal fistulas will not be included.

    Client Benefits:

    Once enrolled, all costs associated with this study (e.g., cyclosporine, sedation medication, stem cell treatment, check-ups, blood draws) will be covered for the duration of the follow-up period (i.e., for 6 months after the last MSC injection). Treatment related complications (such as localized infection, allergic reaction) will be covered up to $1000 by the sponsor. Costs incurred due to unrelated complications will not be covered. Your pet's participation will also allow us to gain information which will help in the diagnosis 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