TissueGene Inc.

Clinical Trials

What is INVOSSA™ (TG-C)?

TG-C is an allogeneic (donor) cell and gene therapy involving primary human chondrocytes (cartilage cells) and chondrocytes transduced to express the therapeutic growth factor TGF-ß1. INVOSSA™ (TG-C) is a combination of the two. It has been developed to treat knee osteoarthritis, and is delivered via one intra-articular injection into the knee.

U.S. Clinical Trial Phase II

U.S. Clinical Trial Phase II

The U.S. Phase II study for INVOSSA™ (TG-C) TG-C was designed as a multi-center, double-blind, placebo-controlled, randomized study to evaluate the safety and efficacy of TG-C in 100 patients with Grade 3 chronic degenerative joint disease of the knee. The primary efficacy endpoints were the IKDC Subjective Knee Evaluation and VAS. One injection demonstrated compelling efficacy results for up to 24 months in improvement in pain and function.

View U.S. Clinical Trial
Planned U.S. Clinical Trial Phase III

Planned U.S. Clinical Trial Phase III

The pivotal program consists of 2 trials:

  • TGC12301: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy of TG-C in Subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee
  • TGC15302: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy and Effectiveness of TG-C in Subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee
View U.S. Clinical Trial Phase III

Highlights of US Phase III Clinical Protocol

Highlights of US Phase III Clinical Protocol

Publications

Learn more about our efforts and findings via our published work.

Read Publications