Dental stem cell study

Species:
Cat

Category:
Dentistry and oral surgery

Status: Open and enrolling
Principal Investigator: 
Stephanie Goldschmidt
BVM&S, DAVDC
Contact:

Dr. Goldschmidt
[email protected]
612-624-4723

I'm Interested

Study title

Prospective, multi-centered clinical trial to evaluate the safety, effectiveness and potency of DentalHeal, Feline Allogeneic Adipose Derived Mesenchymal Stem Cells (MSCs) for the control of clinical signs related to feline chronic gingivostomatitis (FCGS) in cats that do not respond to full or partial mouth extractions (FME or PME) and medical therapy

Purpose of study

Feline chronic gingivostomatitis (FCGS) is a severe, inflammatory oral mucosal disease of cats that is often refractory to treatment. The pathogenesis of FCGS is poorly understood but is thought to represent a host immune system that responds inappropriately to chronic oral antigenic stimulation secondary to underlying oral disease or viral infection. Mesenchymal stem cells (MSC) have a profound immunomodulation capacity, and previous studies have found that 71% of cats with refractory FCGS (i.e cases that did not respond to surgical treatment) responded to autogenic MSC infusion with substantial improvement or complete clinical remission. The purpose of this study is to evaluate the effectiveness of two intravenous (IV) doses of DentalHeal allogeneic MSC on treating refractory FCGS.

Eligibility criteria

  • Over 1 year old
  • Cats diagnosed with feline chronic gingivostomatitis (FCGS) which have already been treated with full or partial mouth extraction and continued to be non-responsive up to 6 months after surgery

Procedures

  • At initial screening, a medical review, physical examination, and blood work will be performed
  • The first injection will be administered IV and your cat will be hospitalized overnight for observation to ensure there are no adverse effects associated with the injection
  • 30 days later, the second IV injection will be given. Again, your cat will spend the night in the hospital for observation. Repeat blood work and physical examination will be performed at this visit.
  • Follow up visits will occur at 1, 3, 6, and 12 months after the first injection. Both bloodwork and a physical examination will be performed at these visits.

Costs

The sponsor covers the cost of the stem cell injections ($1,581.23 value) and all planned blood work as specified in the study design.
All other costs including overnight hospitalization, and veterinary visits are covered by the client.