Kolon TissueGene, Inc., an advanced cell therapies company, announced on Thursday that it has completed its US phase three clinical trials for Knee Osteoarthritis.

The company has completed two large clinical trials involving 1,066 subjects over approximately 30 months.

Completion of patient dosing has allowed the company to complete the trials. The firm collaborated with the US Food and Drug Administration (FDA) to get the clinical hold lifted in April 2020, which allowed resumption of the Phase three clinical trials in the US. The clinical hold was withdrawn via extensive research based on scientific data on TG-C and an intensive regulatory review process.

During the patient recruitment process, around 6,700 subjects signed up to participate. Out of 6,700 subjects, over 1,000 patients met eligibility criteria and were enrolled in the trials. The company is to continue with a two-year follow-up on all dosed patients to evaluate the safety and efficacy after TG-C administration in accordance with the protocol. The outcome of the phase three clinical trials will be published at the end of the two-year follow-up period.