TG-C for Osteoarthritis of the Knee

Recruiting in Palo Alto (17 mi)

+100 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 patients with moderate to severe osteoarthritis. It aims to reduce pain and improve knee function by potentially modifying the disease. TG-C has shown promise in previous studies for managing knee osteoarthritis.

Eligibility Criteria

This trial is for adults aged 40 or older with moderate knee osteoarthritis (Grade 2 or 3), not too thin or overweight, and experiencing significant pain. Participants must consent to the study's terms and use birth control if applicable. Exclusions include severe knee swelling, certain MRI findings, recent injections in the knee, other serious health conditions, drug/alcohol abuse history, and specific medications taken recently.

Inclusion Criteria

OARSI Grade 1 or 2 medial JSN

KL Grade 2 or 3 knee OA

You have been diagnosed with Knee Osteoarthritis

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Exclusion Criteria

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

I have knee problems that make it hard or impossible for me to walk.

Treatment Details

Interventions

Placebo Control (Other)
TG-C (Other)

Trial OverviewThe study tests TG-C's safety and effectiveness against a placebo in improving knee osteoarthritis symptoms. TG-C is given as a one-time injection into the affected joint under ultrasound guidance. The trial will follow patients for two years to see how well it works compared to a dummy treatment.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Active Treatment (TG-C)Active Control1 Intervention

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

Group II: Placebo Control (Normal Saline)Placebo Group1 Intervention

Normal saline, single 2 mL intraarticular injection