Knee Osteoarthritis Clinical Trial
Official title:
A Phase 2, 52-Week Trial of TTAX03 vs. Saline as a Single Intra-articular Injection in Kellgren-Lawrence Grade 3-4 Knee OA
Verified date | April 2024 |
Source | Tissue Tech Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 responders 12 weeks post-injection than an equal volume of saline, based on the OMERACT-OARSI responder criteria.
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | March 1, 2025 |
Est. primary completion date | July 19, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 85 Years |
Eligibility | Inclusion Criteria: - Able and willing to provide written informed consent - = 35 and = 85 years of age (until a cap of 30 subjects < 50 years of age is reached, at which point this will convert to = 50 and = 85 years of age) - Able to reliably complete the KOOS self-administered questionnaire - Clinical diagnosis of OA of the index knee, with pain onset more than one year prior to screening according to subject recall - KL grade 3 or 4 in the index knee - 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) - A = 3 months history of insufficient pain relief from IA hyaluronic acid or a = 3 months history of insufficient pain relief from IA corticosteroids, unless they are medically contraindicated for the subject - A = 3 months history of insufficient pain relief from other currently recommended treatments, including weight loss and physical therapy - Any two of the following: - 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 - Moderate or severe knee pain while resting, either day or night - Chronic knee inflammation and swelling that does not improve with rest or medications - BMI = 40 kg/m2 - Adequate bone marrow function (ANC > 1000 × 109 /L, platelets = 100,000 × 109 /L, Hgb = 10 g/dL) - Adequate hepatic function (AST/ALT = 1.5 × ULN, total bilirubin = 1.2 × ULN) - Adequate renal function (creatinine = 1.2 × ULN) - Negative urine test for opioids (including synthetic opioids) - If female and of child-bearing potential, willingness to use effective birth control during the study. Exclusion Criteria: - Cognitive impairment, mental illness, neuroses or untreated depression that would preclude understanding or reliably completing the patient reported outcome measures - Non-ambulatory, bedridden, or with active fibromyalgia, radiculopathy, painful peripheral neuropathy, vascular insufficiency, hip OA or other joint disease severe enough to prevent assessment of knee pain or causing functional impairment - Current use of opioid analgesics, or positive urine laboratory test for opiates during the screening period - Hyaluronic acid, corticosteroid, platelet rich plasma or stem cells IA knee injections within the prior 3 months, oral or intramuscular corticosteroids within the prior 2 months - Scheduled knee arthroscopy or knee surgery in either knee within 12 weeks from enrollment - Known or suspected joint infection of either knee - History of knee ligament surgery in the past 12 months - Acute injury to the knee in the past 3 months resulting in difficulty walking for more than 24 hours - History of inflammatory joint diseases, crystalline diseases such as gout or pseudogout, systemic lupus, rheumatoid arthritis, autoimmune disease or Crohn's disease - Previous repair of a cruciate ligament, osteochondral autograft transfer, mosaicplasty, subchondral surgery (subchondroplasty) or previously diagnosed subchondral insufficiency fracture - Comorbid conditions that include the following: known other causes of arthritis (infectious arthritis, or psoriatic arthritis), osteomyelitis, cardiopulmonary disease that limits walking more than knee pain, bone metastases or Paget's disease involving the lower extremities. - Psoriasis or other acute or chronic inflammatory conditions or infection affecting the skin over the index knee - Symptoms of locking, intermittent block to range of motion or loose body sensation which could indicate meniscal displacement or an intraarticular loose body in the index knee - Use of anticoagulants (except for = 81 mg of aspirin per day) or a history of any coagulopathy or bleeding disorder, sickle cell disease - History of substance abuse in the past 2 years - Prior or current use of systemic immunosuppressive medications (other than corticosteroids for arthritis), chemotherapy, or history of organ transplant (kidney, heart, lung) - Prior radiation therapy to the index knee - Prior treatment with CLARIX FLO, NEOX FLO, or injectable birth tissue products for any indication - Concurrent treatment, or treatment in the past 90 days, with any investigational agent - Severe concurrent illness which, in the view of the investigator, would interfere with this 52 week study - Any condition which, in the opinion of the investigator, would make a patient a poor candidate for this study - Positive blood pregnancy test or known pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | Paragon Sports Medicine | Atlanta | Georgia |
United States | Alabama Orthopaedic Center | Birmingham | Alabama |
United States | UAB Orthopaedic Surgery | Birmingham | Alabama |
United States | Manage Sites/The Ohio State University Wexner Medical Center, Sports Medicine The Ohio State University Wexner Medical Center, Sports Medicine | Columbus | Ohio |
United States | Ochsner Health Center | Jefferson | Louisiana |
United States | Horizon Clinical Research | La Mesa | California |
United States | Rothman Orthopaedic Institute | Media | Pennsylvania |
United States | Gulfcoast Research Institute | Sarasota | Florida |
United States | Precision Clinical Research | Sunrise | Florida |
United States | Tuscon Orthopedic Institute | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Tissue Tech Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Relief and/or Functional Improvement | Proportion of subjects who, at the end of 12 weeks, report improvement from baseline in pain or in function > or = 50% and absolute change > or = 20; - or - Improvement in at least 2 of the 3 following: pain > or = 20% and absolute change > or = 10 function > or = 20% and absolute change > or = 10 global assessment > or = 20% and absolute change > or = 10 |
12-weeks post Intra-articular Injection | |
Secondary | KOOS Knee Symptoms Subscale | Change from Baseline as a result of the intervention on joint symptoms | 6,12, 26, 39 & 52 weeks from Baseline versus Saline | |
Secondary | KOOS Knee Pain Subscale | Change from Baseline as a result of the intervention on Knee Pain | 6,12, 26, 39 & 52 weeks from Baseline versus Saline | |
Secondary | KOOS Physical Function Subscale | Change from Baseline as a result of the intervention on Physical Function | 6,12, 26, 39 & 52 weeks from Baseline versus Saline | |
Secondary | KOOS Sports and Recreation Subscale | Change from Baseline as a result of the intervention on Sports and Recreation activities | 6,12, 26, 39 & 52 weeks from Baseline versus Saline | |
Secondary | KOOS Quality of Life Subscale | Change from Baseline as a result of the intervention on joint-specific Quality of Life | 6,12, 26, 39 & 52 weeks from Baseline versus Saline | |
Secondary | Patient Global Impression of Change Questionnaire | Change from Baseline as a result of the intervention on patient reported Global Impression of Change | 12, 26, 39 & 52 weeks from Baseline versus Saline | |
Secondary | Overall Change in Pain Relief Medication Use from Baseline | Change in time to and frequency of use of pain relief medications and intra-articular injection of steroids and/or HA | Over the 52 weeks from Baseline versus Saline |
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