Study details

A clinical field study evaluating the effectiveness and safety of allogeneic uterine-derived mesenchymal stem cells for refractory feline chronic gingivostomatitis (FCGS)

Inclusion criteria

Cats must be:

  • At least 1 year old and weigh at least 1 kg (2.2 lbs)
  • Any sex; intact or spayed/neutered, and not pregnant or lactating
  • Client-owned (i.e., not a feral or shelter animal) and can belong to single or multi-cat household; more than one cat per household can be enrolled if eligible
  • Manageable and cooperative with study procedures
  • Diagnosed with FCGS
  • At least 60 days post-surgery for FME or PME. PME cats must have no evidence that remaining teeth are contributing to the FCGS based on clinical examination and imaging (within 30 days of screening) in the opinion of the Investigator (see exclusion criteria for examples of unacceptable findings).
  • Receiving medical management for the FCGS
  • Receiving adequate pain and nutritional management for at least 14 days prior to enrollment
  • Radiographed post-op to confirm there are no retained root tips following tooth extraction(s)

Exclusion criteria

Cats must not:

  • Have been diagnosed with cancer
  • Exhibit any of the abnormalities outlined in the protocol
  • Be participating in a different study with an investigational product
  • Have any procedure involving general anesthesia during the 12-month study
  • Have a concurrent disease which is likely to prevent it from completing the 12-month study or which may interfere with the evaluation of the cat during the study (such as uncontrolled chronic kidney disease, cardiac disease, or diabetes). These cases will be considered on a case-by-case basis in consultation with the sponsor.
  • Have received any of the following treatments at any time before screening (previous stem cell therapy or treatment with platelet-rich plasma or recent treatments expected to interfere with study objectives)

Covered costs

  • All study-related costs including exams, diagnostics, and procedures are covered by the study sponsor
  • $100 owner gift card

Duration of study

  • 11 visits over 12 months

Locations and contacts