TG-C for Knee Osteoarthritis

Recruiting in Palo Alto (17 mi)

+68 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Kolon TissueGene, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests TG-C, an injection into the knee, for people with moderate to severe knee osteoarthritis. It aims to see if TG-C can reduce pain and improve knee function by potentially altering the disease. The study will monitor patients for safety and effectiveness over time. TG-C has been previously studied for its potential to improve knee joint function and reduce pain in osteoarthritis patients.

Research Team

Moon Jong Noh, PhD

Principal Investigator

Kolon TissueGene

Eligibility Criteria

This trial is for adults aged 40 or older with moderate knee osteoarthritis (Grade 2 or 3), experiencing significant pain. Participants must have a BMI between 18.5 and 40, use birth control, and not have severe joint issues, uncontrolled diabetes, recent cancer (except certain skin cancers), infections like HIV/HBV/HCV, or be using certain medications.

Inclusion Criteria

My knee joint space narrowing is mild to moderate.

I am 40 years old or older.

BMI between 18.5 and 40

Exclusion Criteria

I have severe hip arthritis on the same side as my affected knee.

I do not have uncontrolled heart, liver, kidney, adrenal gland disorders, or thyroid issues.

Knee effusion greater than 2+

Treatment Details

Interventions

• Placebo Control (Other)
• TG-C (Other)

Trial Overview The study tests the safety and effectiveness of TG-C compared to a placebo in improving knee osteoarthritis symptoms. TG-C is given as a single injection under ultrasound guidance. Patients are monitored over two years to see how well it works and any side effects.

Participant Groups

Group I: Active Treatment (TG-C) Active Control 1 Intervention

TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection

Group II: Placebo Control (Normal Saline) Placebo Group 1 Intervention

Normal saline, single 2 mL intraarticular injection

Who Is Running the Clinical Trial?

Kolon TissueGene, Inc.

Lead Sponsor

Trials

6

Recruited

1,500+