Gallant

FELINE CHRONIC GINGIVOSTOMATITIS (FCGS) STUDY

Hope for cats with no alternative options

This is potentially the first drug targeting the disease process

We need your help! Do you have feline patients diagnosed with chronic gingivostomatitis (FCGS) based on Stomatitis Disease Activity Index (SDAI) lesion scoring and clinical signs including:

• Licking excessively

• Drooling

• Reduced grooming

• Vocalization

• Bleeding gums

• Ulcers in the mouth

If so, those patients may be eligible for a pivotal study to support FDA-approval of an allogeneic, ready-to-use stem cell therapy for control of their clinical disease associated with FCGS.

WHY SHOULD YOU AND YOUR CLIENT CONSIDER THIS STUDY?

  • Stem cells offer a treatment option for cats that have not responded to tooth extraction and medical management
  • Your client's cat will receive specialty veterinary care throughout the study, including physical exams, blood work, and urinalysis at NO OUT OF POCKET cost to the pet parent.
  • You and your client's cat may play an important role in advancing feline medicine.

This study may be used to support a new animal drug application intended to be submitted to the Food and Drug Administration.

Why Stem Cells?

Stem cells are naturally occurring cells that exist in adult tissues and have regenerative properties (help tissues repair and heal). These stem cells have the ability to immunomodulate (regulation of the immune system to be adaptive) through cellular signaling. This provides a natural and targeted mechanism for treatment of the underlying disease.

The mesenchymal stem cells (MSCs) used in this product are derived from a healthy donor cat’s uterus that is collected during a routine spay procedure. The cells are harvested, cultured, expanded, and frozen to provide a source of live cells once thawed at the time of treatment.

There have been multiple studies demonstrating the ability of adult mesenchymal stem cells to improve lesions scores and, more importantly, clinical status of feline patients suffering from refractory FCGS.

Interested in Participating in the Clinical Trial?