Conducted in collaboration with researchers from the UC Davis School of Veterinary Medicine, this is the first country-wide clinical trial to evaluate the safety, efficacy and potency of VetCell Therapeutics’ feline allogeneic MSC therapy for treating FCGS.
VetCell Therapeutics USA™, a clinical-stage, pet-focused cell therapy division of PrimeGen US Inc., announced last week that it has received authorization from the U.S. Food and Drug Administration (FDA) to begin a multi-centered, country-wide clinical trial to evaluate the safety, effectiveness and potency of DentaHeal™, its investigational cell therapy product, for the control of clinical signs related to feline chronic gingivostomatitis (FCGS). The 200-cat trial will focus solely on treating patients with FCGS that have not responded to full- or partial-mouth extractions and medical therapy.
This authorization represents a major milestone for VetCell Therapeutics USA, as it can now treat feline patients suffering from FCGS with DentaHeal. DentaHeal is an allogeneic, adipose-derived, mesenchymal stem cell treatment. This minimally invasive, intravenously administered cell therapy may help to correct immune abnormalities associated with FCGS in cats.
This novel therapy was developed at the UC Davis School of Veterinary Medicine, where Dr. Boaz Arzi, DVM, DAVDC, DEVDC, FF-AVDC-OMFS led a successful clinical trial of an investigational MSC product. That pilot study provided the foundation for a patent, which VetCell Therapeutics USA acquired in order to pursue FDA approval for its DentaHeal cell therapy.
Approximately 30 percent of FCGS patients do not respond to standard treatments and require life-long pain medication, antibiotics and immunosuppressive drugs. Sadly, the cats that do not improve, even with implementation of improved dental hygiene, medicines, and oral surgery, are often euthanized.
“FCGS is a terribly debilitating, immune-mediated disease and sadly, the outlook for cats that do not respond to available treatments is bleak,” said Dr. Chad B. Maki DVM, Chief Veterinary Medical Officer, VetCell Therapeutics USA. “Our vision is that DentaHeal will dramatically improve the quality of life for cats with FCGS by completely resolving or substantially improving their condition and provide them with long-term remission and relief.”
Currently, there is no FDA-approved cell therapy product for treating FCGS. The intent of this investigational trial is to evaluate DentaHeal as an innovative, drug-free treatment for FCGS. Led by principal investigator Dr. Boaz Arzi, up to 200 cats will be enrolled based on the protocol eligibility criteria as assessed by experienced board-certified veterinarians. This trial will be conducted in collaboration with UC Davis’ Veterinary Institute for Regenerative Cures (VIRC).
“This is a massive milestone for VetCell Therapeutics USA. Our dedicated and passionate team has worked tirelessly to advance to the clinical stage, and I believe the work being put into R&D and clinical trials will position VetCell as the catalyst for cell therapy becoming a mainstay of veterinary medicine,” said Tom C.K. Yuen, founder and chairman of PrimeGen Global, the parent company of VetCell Therapeutics USA.
VetCell Therapeutics USA plans to start recruitment for this clinical trial this month. The FDA has authorized VetCell Therapeutics USA to recover the direct costs from a pet owner for the manufacturing (e.g.: raw materials, labor and non-reusable supplies and equipment) and shipping and handling of two-dose treatments of DentaHeal.
To learn more about the FCGS stem cell trial, visit www.vetcelltherapeuticsusa.com/FCGS_Trial.