TTAX03 Injection for Knee Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if an injection called TTAX03 can reduce knee pain more effectively than a saltwater placebo in individuals with knee osteoarthritis. Participants will receive a single injection and be monitored for 12 weeks to track improvements. The trial seeks individuals who have had knee osteoarthritis for over a year, frequently experience severe knee pain or stiffness that limits daily activities, and have tried other treatments without sufficient relief. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to potentially experience relief from knee pain.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop all current medications, but you cannot use opioid painkillers or have had certain knee injections or treatments in the past few months. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatment TTAX03 is generally safe for people. In an earlier study, participants who took TTAX03 reported side effects similar to those who received only a saltwater solution, indicating the treatment is well-tolerated. Additionally, the FDA has approved TTAX03 for testing in other studies, signaling its safety. Overall, the evidence supports that TTAX03 is safe for human use.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for knee osteoarthritis, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroid injections, TTAX03 is derived from human amniotic membrane and umbilical cord tissue. This unique composition preserves extracellular matrices and growth factors, which may enhance healing and reduce inflammation without involving living cells. Researchers are excited about TTAX03 because it offers a novel mechanism that could address both pain and the underlying joint condition, potentially leading to more effective and longer-lasting relief than current options.
What evidence suggests that TTAX03 might be an effective treatment for knee osteoarthritis?
Research shows that TTAX03, derived from human birth tissues, could help treat knee osteoarthritis. In this trial, some participants will receive an injection of TTAX03, which early studies suggest might relieve pain more effectively than a saltwater injection. This treatment preserves important growth factors that can help reduce knee inflammation and pain. Previous patients have experienced better outcomes and pain relief with similar treatments. Although more information is still being gathered, these early results offer promise for those seeking new ways to ease knee osteoarthritis pain.12678
Are You a Good Fit for This Trial?
Adults aged 35-85 with chronic knee pain and swelling from osteoarthritis (KL grade 3 or 4), who haven't found relief with other treatments like hyaluronic acid or corticosteroids. Participants should have a BMI ≤40, no severe joint diseases besides OA, not be using opioids, and women of childbearing age must use birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intra-articular injection of TTAX03 or saline
Initial Follow-up
Participants have safety follow-up visits post-injection
Primary Endpoint Evaluation
Evaluation of response at 6 and 12 weeks post-injection
Extended Follow-up
Participants are monitored for duration of benefit and overall impression of change
What Are the Treatments Tested in This Trial?
Interventions
- Saline
- TTAX03
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioTissue Holdings, Inc
Lead Sponsor
Tissue Tech Inc.
Lead Sponsor