Efficacy of mesenchymal stem cell therapy for treatment of canine Granulomatous Meningoencephalomyelitis (GME)

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. Not Currently enrolling patients

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.