Stem Cell Therapies

Clinical trials for Stem Cell Therapies

  • Protocol identification:  CSRC 004-13, approved 2/4/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:  Mary Labato, DVM, DACVIM (Small Animal Internal Medicine)
    Contact information: mary.labato@tufts.edu, (508) 839-5395, ext ext 4825
    Status of trial:  not currently enrolling

    Inclusion criteria: Dogs presenting with protein-losing nephropathy, hypoalbuminemia (<2.4 g/dl), azotemia ( creatinine > 2.5 mg/dl), thrombocytopenia ( platelets < 160,000) and hypercoagulable state; renal biopsy confirmation of diagnosis of immune complex glomerulonephritis.

    Exclusion criteria: Dogs not expected to live greater than 48 hours, those with cardiac disease, and those with neoplasia. Also excluded will be those dogs with an active bacterial urinary tract infection, and those suspected or confirmed to have leptospirosis.

    Arms/interventions:  This is a single arm open-label pilot study.  All dogs (n=6) in this study will receive a single injection of hES-MSCs intravenously once eligibility criteria are met.  Standard of care will continue throughout the trial (90 days).

    Potential direct or indirect benefits from the study (for owners and RDVM): The study will cover all of the costs that are typically accrued in the diagnostic evaluation of dogs with protein-losing nephropathy including complete blood count, chemistry profile, urinalysis, urine culture, urine protein:creatinine ratio (UPC), thromboelastograph (a clotting profile), antithrombin level (to see if your dog is a risk for forming blood clots), ANA (looking for lupus) , serology for tick borne diseases and leptospirosis. It will also cover an abdominal ultrasound examination and the cost of a kidney biopsy.  The study will also cover for follow up blood work and urinalyses during the 90 days of the study, including 2, 7, 14, 30, and 90 days after treatment.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 508 887 4589).
    • To reach the Principal Investigator, see contact information listed above.
    • For all other questions concerning clinical trials, please contact Dr. Andrew Hoffman (Director, Regenerative Medicine Laboratory) at andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 006-13, approved 3/25/13

    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:  Cynthia Leveille-Webster, DVM, DACVIM (SA Internal Medicine)
    Contact information:  cynthia.leveille-webster@tufts.edu, (508) 839-5395, ext 84542
    Status of trial:  not currently enrolling

    Inclusion criteria:  Labrador Retrievers with histological diagnosis of moderate to severe chronic hepatitis (based on ‘Cornell hepatic scoring system’ which grades interface hepatitis, portal inflammation and lobular apoptosis/necrosis) and a serum ALT that is at least 3 times the upper limit of normal will be enrolled.

    Exclusion criteria:  presence of infectious disease (positive cultures of the liver or bile or positive titers for Leptosporosis), exposure to known hepatotoxic medications or supplements within the last month, the presence of extrahepatic bile duct disease (revealed by diagnostic imaging), severe co-morbidity (cardiac, renal or respiratory disease, evidence of end stage hepatic failure signified by the presence of large volume ascites, serum albumin less than 1.5 g/dl or clinical scores greater than 12), a histopathologic diagnosis of cancer and the presence of thromboembolic disease (splenic or portal vein thrombosis on ultrasound).  Evidence of SIRS or shock of any origin would exclude the patients.   Patients receiving corticosteroids within the last 2 months would be excluded.

    Arms / interventions:  This is a single arm open-label pilot study.  All dogs (n=6) in this study will receive a single intravenous injection of hES-MSCs once eligibility criteria are met.  Standard of care will be maintained throughout the trial with exception that dogs will not be able to receive corticosteroids or immunosuppressive agents for the first 42 days after injection of MSCs.

    Potential direct or indirect benefits from the study (for owners and RDVM):  The study will cover some of the costs.  Owners will be reimbursed for the expenses associated with the liver biopsy (including charges for the laparoscopic surgery and the charges for the pathologist to examine the slide) IF the biopsy is supportive of the diagnosis.  All of the expenses associated with giving the injection of stem cells and in evaluating your pet after the injection will be covered.  This will include CBC and serum chemistries at 1, 3, and 6 weeks and 3 and 6 months after stem cell injections.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 508 887 4589).
    • To reach the Principal Investigator, see contact information listed above.
    • For all other questions concerning clinical trials, please contact Dr. Andrew Hoffman (Director, Regenerative Medicine Laboratory) at andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 030-13, approved 10/15/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:  Lluis Ferrer DVM, PhD, DECVD (Dermatology)
    Contact information:  lluis.ferrer@tufts.edu, (508) 839-5395, ext 84419
    Status of trial:  Enrollment start date:  Jan 27, 2014

    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 history of failure to respond completely to cyclosporine A therapy.

    Exclusion criteria:   Dogs younger than 1 year or older than 10 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.

    Arms/interventions:  This is a single arm open-label pilot study (n=6).  Dogs will receive hES-MSCs injected intra-lesionally (distributed evenly between fistulas) and covered by an FDA approved fibrin sealant (Evicel).  Dogs will be maintained on cyclosporine A at the same dose for the first 60 days after injection of the hES-MSCs, and then withdrawn for as long as they remain in clinical remission.

    Potential direct or indirect benefits from the study:  The study will cover all of the costs of this study including initial examination, stem cell treatment, ~$300 towards Cyclosporine treatment, and recheck examinations at 1, 2, 3, and 6 mos after injection of MSCs.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 508 887 4589).
    • To reach the Principal Investigator, see contact information listed above.
    • For all other questions concerning clinical trials, please contact Dr. Andrew Hoffman (Director, Regenerative Medicine Laboratory) at andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 035-13, approved 10/25/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:   Phil March, DVM, PhD, DACVN (Neurology).
    Contact information:  philip.march@tufts.edu, (508) 839-5395, ext 84953
    Status of trial:  Enrollment start date:  Jan 27, 2014.

    Inclusion criteria:  A clinical diagnosis of GME based on intracranial neurologic signs that are consistent with the typical neuro-anatomical distribution of GME; corroboration of clinical findings with MRI findings of multifocal lesions in regions of white matter; CSF findings typical of GME (total white blood cell count >50 cells per µl with a predominance of lymphocytes and monocytes/ macrophages); client consent to treat with MSCs as adjunctive therapy for GME.

    Exclusion criteria:   Dogs with necrotic or grey matter predominant forms of encephalitis (e.g. necrotizing meningoencephalitis).  Evidence of infectious disease on serology, PCR, or culture; significant pre-existing concurrent systemic illness (liver, renal, cardiac, etc.) based on routine clinical and laboratory testing (complete blood count, chemistry profile, and urinalysis); positive results of patient serum on the complement lysis assay (screen for patient auto-antibodies to human cells)

    Arms / Interventions:  This is a double arm, randomized controlled open-label study of adjunct effects of hES-MSCs added to standard of care.  Dogs (n=3/group) will be randomized to receive either (1) high dose corticosteroids (tapered over 8 wks) and intravenous hES-MSCs or (2) high dose corticosteroids (tapered over 8 wks) and procarbazine for 8 weeks followed by a single intravenous injection of hES-MSCs.

    Potential direct or indirect benefits from the study: The study will cover all costs associated with administering the hES-MSC treatment, all follow up hospital visits and exams (2, 4, 6, 8, 12, 16, 20, and 24 weeks post-treatment with hES-MSCs), all costs associated with biomarker analysis, and all costs associated with the follow up MRI at 8 weeks post-hES-MSC treatment.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 508 887 4589).
    • To reach the Principal Investigator, see contact information listed above.
    • For all other questions concerning clinical trials, please contact Dr. Andrew Hoffman (Director, Regenerative Medicine Laboratory) at andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 038-13, approved 10/9/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:   Mike Kowaleski, DVM, DACVS / EVCS (Surgery)
    Contact information:  mike.kowaleski@tufts.edu, (508) 839-5395 ext 84659
    Status of trial:  Enrollment start date, Jan 27, 2014.

    Inclusion criteria:  Signalment:  15-10 kg; 10 months – 12 years of age; any gender.  Chronic, bilateral elbow osteoarthritis resulting in symptomatic forelimb lameness secondary to elbow osteoarthritis evident on clinical examination, confirmed radiographically with no clinical, hematological, or biochemical evidence of systemic disease.

    Exclusion criteria:   Systemic disease, other sources of musculoskeletal lameness (e.g. polyarthritis), reliance on daily oral NSAID or steroid therapy, aggression or behavioral disorders, exercise intolerance, recent (< 3 months) joint injections of non-cell or platelet derived products, or recent (< 6 months) elbow joint surgery.

    Arms / Interventions:   This is a single arm open-label pilot study of 6 patients.  The elbow joint of the lamer limb will be injected with hESC-MSCs.  The joint injections will be performed with standard sterile technique, under heavy sedation.

    Potential direct or indirect benefits from the study:   The study will cover all costs associated with screening candidates including radiographs and associated sedation.   The study will also cover the costs of administering the hES-MSC treatment and all follow up hospital visits and exams, including initial and 2, 4, 8, and 12 weeks.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 508 887 4589).
    • To reach the Principal Investigator, see contact information listed above.
    • For all other questions concerning clinical trials, please contact Dr. Andrew Hoffman (Director, Regenerative Medicine Laboratory) at andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 045-13, approved 11/19/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigators:  Elizabeth Rozanski, DVM, DACVIM / DACVECC ext 84542, and Claire Sharp DVM, MS, DACVECC, ext 87934
    Contact information:  Elizabeth.rozanski@tufts.edu, (508) 839-5395, Ext 84745
    Status of trial:  Enrollment start date Jan 27, 2014.

    Inclusion Criteria:   Six dogs of either sex with a clinical diagnosis of abdominal sepsis due to GI perforation, whose owner has elected surgery, will be enrolled with owner consent. Diagnosis of abdominal sepsis is established by cytological evaluation of abdominocentesis fluid, confirming the presence of intracellular bacteria (e.g. bacteria visualized within neutrophils).   Abdominocentesis is clinically prompted by abdominal pain, fever, and effusion visualized on radiographs or by ultrasound.

    Exclusion criteria:  Dogs will be excluded from the study if they have GI perforation associated with neoplasia since this etiology is more likely associated with systemic disease, and potentially a worse outcome. GI neoplasia will be identified via abdominal ultrasonography confirming either a solitary GI mass, or enlarged abdominal lymph nodes and diffusely thickened intestinal loops consistent with GI lymphoma. Additionally, dogs will be excluded if they present in a moribund state and are not expected to survive initial stabilization and surgical exploration. Given the daily blood collection associated with this study we will exclude dogs weighing less than 5kg.

    Arms and interventions:   This is a single arm open-label pilot study.   Dogs in this study will receive intravenous hES-MSCs following gastrointestinal surgery and recovery from anesthesia.

    Potential direct or indirect benefits of participation:   The study will cover some of the costs of your dog’s care, including $500 towards the cost of surgery to repair the intestinal leakage, laboratory testing to monitor your pet’s progress.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 508 887 4589).
    • To reach the Principal Investigator, see contact information listed above.
    • For all other questions concerning clinical trials, please contact Dr. Andrew Hoffman (Director, Regenerative Medicine Laboratory) at andrew.hoffman@tufts.edu.
  • Protocol identification: CSRC 043-13, approval pending clarifications.
    Sponsor: Advanced Cell Technology, Marlborough, MA
    Principal Investigator: Dominik Faissler, DVM, Diplomate ECVN (Neurology)
    PI contact information: dominik.faissler@tufts.edu, (508) 839-5395 ext 88758
    Status of trial: Anticipated enrollment start date: Jan 27, 2014.

    Inclusion criteria: Chondrodystrophic dogs, any sex, any age range, weight (5-20 kg bwt), paraplegia with absent pain perception in hind legs and tail at admission; extradural compression between T3-L3 diagnosed with myelogram, CT or MRI. Acute disk extrusion confirmed at surgery.

    Exclusion criteria: Unable to confirm intraoperative disk extrusion, concurrent disease that could interfere with neurologic recovery, inability to obtain in-hospital follow-up performed at Tufts University by the neurology service, or lack of owner consent.

    Arms / interventions: This is an single arm open-label pilot study. Dogs which quality will receive a single subdural injection of hES-MSCs at the time of hemi-laminectomy.

    Potential direct and indirect benefits from participation: The study will cover the costs of the stem cell therapy, and recheck examinations at 1, 3, 7, 14, and 42 days and 12 wks, and bloodwork at 7, 14, and 42 days and 12 weeks after hES-MSC treatment.