TTAX03 Injection for Knee Osteoarthritis

No longer 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

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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.

withpower.com

withpower.com/trial/phase-3-osteoarthritis-knee-9-2021-234f0

TTAX03 Injection for Knee Osteoarthritis · Info for Participants

A single injection of triamcinolone hexacetonide (THA) significantly improved patient-reported outcomes and pain relief in knee osteoarthritis (OA) patients, ...

2.

ctv.veeva.com

ctv.veeva.com/study/lyophilized-and-micronized-particulate-human-amniotic-and-umbilical-cord-ttax03-for-kl-grade-3-4-k

Lyophilized and Micronized Particulate Human Amniotic and ...

It is hypothesized that a single Intra-articular Injection of TTAX03, 100mg in 2mL of saline, will have more benefit with respect to the proportion of ...

3.

trial.medpath.com

trial.medpath.com/clinical-trial/92325e138c1bad81/nct05079035-ttax03-vs-saline-knee-oa

Lyophilized and Micronized Particulate Human Amniotic and ...

It is hypothesized that a single Intra-articular Injection of TTAX03, 100mg in 2mL of saline, will have more benefit with respect to the proportion of ...

4.

withpower.com

withpower.com/clinical-trials/for-osteoarthritis-near-san-diego-ca

Top Osteoarthritis Clinical Trials near San Diego, CA | Power

This trial tests if a single injection of TTAX03 in saltwater can improve knee conditions better than just saltwater. It targets patients needing knee ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04719793

Umbilical Cord Derived Wharton's Jelly for Knee ...

The purpose of this study is to determine the safety and efficacy of intraarticular injection of umbilical cord derived Wharton's Jelly for treatment of knee ...

6.

biospace.com

biospace.com/tissuetech-receives-fda-clearance-to-proceed-with-phase-1-clinical-study-using-investigational-new-drug-ttax03-to-treat-facet-joint-osteoarthritis-pain

TissueTech Receives FDA Clearance to Proceed with ...

TissueTech Receives FDA Clearance to Proceed with Phase 1 Clinical Study using Investigational New Drug TTAX03 to Treat Facet Joint ...

7.

prnewswire.com

prnewswire.com/news-releases/tissuetech-receives-fda-clearance-to-proceed-with-phase-1-clinical-study-using-investigational-new-drug-ttax03-to-treat-facet-joint-osteoarthritis-pain-301242509.html

TissueTech Receives FDA Clearance to Proceed with ...

TissueTech had received clearance from the US Food and Drug Administration (FDA) to proceed with a dosing study using its Investigational New Drug (IND) TTAX03 ...

8.

go.drugbank.com

go.drugbank.com/conditions/DBCOND0032623

Osteoarthritis of the Knee (DBCOND0032623)

Pivotal Clinical Trial to Evaluate the Efficacy and Safety After NPNP-001 Application in Patients with Knee Osteoarthritis. No drug interventions, treatment, 3 ...