FCGS Clinical Trial
WHAT IS FCGS?
Feline Chronic Gingivostomatitis (FCGS) is a severe and painful inflammatory disease involving the mouth and gums of cats. In most cases, the disease causes ulcers at the back of the mouth, tongue, gums, and occasionally the lips. FCGS affects cats of any age or breed.
WHAT IS DENTAHEAL?
DentaHeal is a stem cell-based product for the treatment of FCGS. This cell therapy may help to correct abnormalities associated with FCGS in cats. In this investigational clinical trial, we are evaluating the safety and effectiveness of using stem cells to treat cats with FCGS that have not had success with other treatments.
WHY CELL THERAPY?
Currently, there is no FDA-approved cell therapy product for treating FCGS. In the past eight years, there have been investigational clinical trials using feline adult stem cells for therapy of FCGS.
With more than 45 patients treated using investigational MSC therapies at UC Davis, approximately 70% have responded favorably to the treatment, either experiencing complete resolution or substantial clinical improvement, and these patients have remained in remission. (published and unpublished data)*
* Source: Arzi et al, Stem Cell Transl Med 2017;6:1710-1722.
There is no FDA approved cell therapy for FCGS
Does Your Cat Qualify?
CLINICAL TRIAL PARTICIPATION REQUIREMENT:
In this investigational study intended to evaluate the safety and effectiveness of DentaHeal, we are recruiting cats that are diagnosed with FCGS, which have not been cured by any currently available treatments. Patients must have had full or partial mouth extractions performed, confirmed with dental radiographs.
OWNER RESPONSIBILITIES:
- The expense of scheduled, study-specific veterinarian visits and treatments
- DentaHeal cell therapy based on VetCell Therapeutics USA’s actual per unit production cost
- Bringing your cat to the clinic for all scheduled appointments and follow up exams
BENEFITS:
- VetCell Therapeutics USA covers the cost of CBC, chemistry and FIV/FeLV screenings during scheduled study visits
- Participation in this study could potentially improve quality of life for your cat
- Results from the study could help other cats with the same condition and may even have implications for human medical disorders
- This therapy trial may provide your cat relief from FCGS
- This therapy could improve or save the lives of cats with FCGS
- Your cat will play an important role in advancing the future of veterinary medicine and cell therapy
POTENTIAL RISKS:
Paw swelling, increased respiratory rate and vomiting
DentaHealTM was developed as an MSC product based on the research conducted by veterinary scientists at UC Davis’ Veterinary Institute for Regenerative Cures (VIRC).
The data from the study will be submitted to FDA to support approval. FDA authorized VetCell Therapeutics USA to recoup costs for the investigational product in this study.
Principal Investigator
Dr. Boaz Arzi, DVM, DAVDC, DEVDC, FF-AVDC-OMFS
Professor of Dentistry and Oral Surgery, Director of The Veterinary Institute for Regenerative Cures
School of Veterinary Medicine, UC Davis
Interested in Enrolling Your Cat in the Trial? Send Us a Note.
Contact Us
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