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: email@example.com, (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.
- Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees: Ms. Dawn Meola (firstname.lastname@example.org, 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 email@example.com.