Clinical Trial Synopsis:


A Phase 1 Study to Determine the Safety and Biological Activity of Cell-Mediated Gene Therapy Using TissueGene-C (TG-C) in Patients with Degenerative Joint Disease of the Knee Prior to Total Knee Arthroplasty

Objectives:

Primary:
  • To evaluate the safety and activity of intra-articularly administered TG-C.

Secondary:
  • To evaluate dose response of the hChon cells in engrafting at the defect.
  • To evaluate distribution of hChon cells out of the injection site.
  • To evaluate the regeneration of hyaline cartilage as determined by the histological analysis of the resected knee tissue.
  • To evaluate the joint for evidence of tissue overgrowth or transformation.
  • To evaluate the resected knee tissue for expression of a panel of specific genes associated with the biological activity of TG-C.

Study Population:

male or female patients, age 18 and older, with degenerative arthritis (DA) of the knee joint refractory to existing therapies, who are scheduled for surgical replacement of the knee.