TTAX03 Injection for Knee Osteoarthritis

Recruiting at 9 trial locations

Overseen By Tyler Richardson

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioTissue Holdings, Inc

Must not be taking: Opioids, Anticoagulants, Immunosuppressives, others

Disqualifiers: Cognitive impairment, Non-ambulatory, Inflammatory joint diseases, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 1 day

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if a single injection of TTAX03 in saltwater can improve knee conditions better than just saltwater. It targets patients needing knee injections and checks their response over a few months.

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 TTAX03 Injection for Knee Osteoarthritis safe for humans?

In a study comparing different treatments for knee osteoarthritis, saline (another name for TTAX03) was used as a control and showed no drug-related serious adverse events or deaths. Adverse events were similar between those who received saline and another treatment, indicating it is generally safe. ^{1 2 3 4 5}

How does the TTAX03 injection differ from other treatments for knee osteoarthritis?

The TTAX03 injection for knee osteoarthritis is unique because it involves genetically engineered chondrocytes that express TGF-β1, which may help reduce cartilage damage and inflammation more effectively than traditional treatments. This approach is different from standard options like corticosteroids or pain management injections, as it aims to address the underlying joint damage and inflammation. ^{1 2 6 7 8}

What data supports the effectiveness of the TTAX03 treatment for knee osteoarthritis?

Research shows that injections containing corticosteroids, like triamcinolone hexacetonide, can help reduce pain and improve function in knee osteoarthritis. Additionally, saline injections are often used as a control in studies, suggesting they may have some placebo effect in pain management. ^{1 2 6 7 9}

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

Able to reliably complete the KOOS self-administered questionnaire

I am between 35 and 85 years old, or over 50 if 30 younger participants have already joined.

I am willing to use effective birth control during the study.

Exclusion Criteria

I've had a knee injury in the last 3 months that made it hard to walk for over a day.

I have had surgery on my knee for ligament repair or bone grafting.

Concurrent treatment, or treatment in the past 90 days, with any investigational agent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-articular injection of TTAX03 or saline

1 day

1 visit (in-person)

Initial Follow-up

Participants have safety follow-up visits post-injection

2 weeks

3 visits (in-person)

Primary Endpoint Evaluation

Evaluation of response at 6 and 12 weeks post-injection

12 weeks

2 visits (in-person)

Extended Follow-up

Participants are monitored for duration of benefit and overall impression of change

52 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Saline
• TTAX03

Trial Overview The trial is testing if a single injection of TTAX03 (a treatment derived from human amniotic and umbilical cord tissues) can provide more relief for knee arthritis pain after 12 weeks compared to a saline placebo, based on established responder criteria.

How Is the Trial Designed?

Group I: Experimental: TTAX03 Experimental Treatment 1 Intervention

TTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic processing followed by terminal sterilization by gamma irradiation in compliance with current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells. TTAX03 is suspended in a volume of 2.0mL of sterile, preservative free 0.9% NaCl.

Group II: Control: Saline Placebo Group 1 Intervention

2.0mL of sterile, preservative free 0.9% NaCl alone

Who Is Running the Clinical Trial?

BioTissue Holdings, Inc

Lead Sponsor

Trials

17

Recruited

970+

Tissue Tech Inc.

Lead Sponsor

Trials

16

Recruited

900+

Published Research Related to This Trial

A single injection of triamcinolone hexacetonide (THA) significantly improved patient-reported outcomes and pain relief in knee osteoarthritis (OA) patients, with 78% reporting improvement at week 1 compared to 49% in the placebo group.

The effectiveness of THA was particularly enhanced in patients with joint effusion and those who had synovial fluid aspirated during the injection, indicating that these factors may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. Gaffney, K., Ledingham, J., Perry, JD.[2022]

Citations

1. Pakistan pubmed.ncbi.nlm.nih.gov

Localized Injection of Streptomycin, Kenacort and Lidocaine combination for Symptomatic Pain Management of Knee Osteoarthritis. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effect of regenerative injection therapy on function and pain in patients with knee osteoarthritis: a randomized crossover study. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Corticosteroid Injections for Symptomatic Treatment of Osteoarthritis of the Knee: A Pilot Blinded Randomized Trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Comparison between intra-articular Botulinum toxin type A, corticosteroid, and saline in knee osteoarthritis: a randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Preliminary Trial of Intra-articular LMWF-5A for Osteoarthritis of the Knee. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Intra-Articular Injection of Botulinum Toxin for the Treatment of Knee Osteoarthritis: A Systematic Review of Randomized Controlled Trials. [2023]

8. India pubmed.ncbi.nlm.nih.gov

Comparison between intra-articular injections of corticosteroids, hyaluronic acid, PRP and placebo for thumb base osteoarthritis: A frequentist network meta-analysis. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Results of a Phase II Study to Determine the Efficacy and Safety of Genetically Engineered Allogeneic Human Chondrocytes Expressing TGF-β1. [2020]