What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, particularly those involving intra-articular injections like corticosteroids and hyaluronic acid, can have side effects such as joint infection, post-injection flare, and potential cartilage damage with repeated use. Nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with gastrointestinal issues, cardiovascular risks, and renal side effects. Duloxetine, an alternative for those who cannot use NSAIDs, may cause nausea, dry mouth, and fatigue. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

FDA-approved treatments for osteoarthritis primarily focus on pain relief and improving joint function. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen are commonly used for their efficacy in reducing pain and inflammation. Intra-articular corticosteroid injections are also approved for short-term pain relief in patients with moderate to severe pain. Hyaluronic acid injections, although less commonly recommended, are another option for joint lubrication and pain relief. While platelet-rich plasma (PRP) and other regenerative therapies are being investigated, they are not widely endorsed due to inconsistent results and lack of long-term efficacy data.

What other types of research exist?

Promising novel alternatives to TTAX03 for osteoarthritis patients include: 1) Ketoprofen in Transfersome® gel (IDEA-033), which has shown efficacy in reducing pain in knee osteoarthritis. 2) Yellow Oil Formulation 3 (YOF3), which has been found noninferior to indomethacin in relieving knee pain. 3) ONO-4474, an orally available pan-tropomyosin receptor kinase inhibitor, which has demonstrated efficacy in patients with moderate to severe knee osteoarthritis. 4) Diclofenac etalhyaluronate (DF-HA), a sustained-release formulation that has shown pain reduction in knee osteoarthritis.

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TTAX03 Injection for Knee Osteoarthritis

Phase 2

Waitlist Available

Research Sponsored by BioTissue Holdings, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Severe knee pain or stiffness that limits everyday activities, including walking, climbing stairs, and getting in and out of chairs. Finding it hard to walk more than a few blocks without significant pain and need to use a cane or walker

Pain score (KOOS) over the past week ≥ 70 in the index knee at Screening (the index knee will be the more painful knee by ≥ 20 in the case of bilateral disease)

Must not have

Previous repair of a cruciate ligament, osteochondral autograft transfer, mosaicplasty, subchondral surgery (subchondroplasty) or previously diagnosed subchondral insufficiency fracture

Prior radiation therapy to the index knee

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6,12, 26, 39 & 52 weeks from baseline versus saline

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the specific side effects are not listed here, similar injections may cause temporary pain at the injection site, swelling, infection risk increase, allergic reactions or no improvement in knee pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe knee pain that limits my daily activities like walking or climbing stairs.

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My knee pain score is 70 or above.

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I experience moderate to severe knee pain, even when resting.

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My blood tests show my bone marrow is working well.

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My kidney function is within normal limits.

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My knee stays swollen and painful despite rest or medication.

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My liver tests are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had radiation therapy on my knee.

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I haven't had knee injections or taken steroids in the last 2-3 months.

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I have a history of inflammatory or autoimmune joint diseases.

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I feel like my knee locks or has something loose inside.

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I have used immunosuppressive drugs, had chemotherapy, or an organ transplant.

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I do not have conditions like severe heart disease or other types of arthritis affecting my walking more than my knee pain does.

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I cannot walk or leave my bed due to severe pain or joint disease.

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I have previously been treated with CLARIX FLO, NEOX FLO, or injectable birth tissue products.

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I had knee ligament surgery within the last year.

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I have psoriasis or another skin condition affecting my knee.

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I am currently using opioid painkillers or have tested positive for them recently.

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I don't use blood thinners (except low-dose aspirin) and don't have bleeding disorders or sickle cell disease.

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I might have an infection in my knee joint.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6,12, 26, 39 & 52 weeks from baseline versus saline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6,12, 26, 39 & 52 weeks from baseline versus saline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6,12, 26, 39 & 52 weeks from baseline versus saline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Relief and/or Functional Improvement

Secondary study objectives

KOOS Knee Pain Subscale

KOOS Knee Symptoms Subscale

KOOS Physical Function Subscale

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental: TTAX03Experimental Treatment1 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: SalinePlacebo Group1 Intervention

2.0mL of sterile, preservative free 0.9% NaCl alone

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoarthritis (OA) include nonsteroidal anti-inflammatory drugs (NSAIDs), which reduce inflammation and pain by inhibiting cyclooxygenase enzymes (COX-1 and COX-2). Duloxetine, an antidepressant, works by modulating pain pathways through serotonin and norepinephrine reuptake inhibition. Intraarticular injections, such as glucocorticoids, provide short-term pain relief by reducing local inflammation. Investigational therapies like platelet-rich plasma (PRP) aim to promote tissue repair through growth factors, though evidence is mixed. Gene therapy approaches, such as TissueGene-C, involve modifying cellular functions to enhance cartilage repair and reduce pain. Understanding these mechanisms helps OA patients and their doctors choose the most appropriate treatment based on the specific pathophysiology of their condition and the desired therapeutic outcomes.

Osteoarthritis of the knee - biochemical aspect of applied therapies: a review.