Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord (TTAX03) for KL Grade 3-4 Knee OA
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ClinicalTrials.gov Identifier: NCT05079035 |
Recruitment Status :
Active, not recruiting
First Posted : October 15, 2021
Last Update Posted : April 10, 2024
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Condition or disease | Intervention/treatment | Phase |
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Knee Osteoarthritis Knee Pain Chronic Knee Arthritis | Biological: TTAX03 Biological: Saline | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | December 6, 2021 |
Estimated Primary Completion Date : | July 19, 2024 |
Estimated Study Completion Date : | March 1, 2025 |
Arm | Intervention/treatment |
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Experimental: Experimental: TTAX03
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.
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Biological: TTAX03
Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord |
Placebo Comparator: Control: Saline
2.0mL of sterile, preservative free 0.9% NaCl alone
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Biological: Saline
2 mL Sterile, preservative free 0.9% NaCl |
- Pain Relief and/or Functional Improvement [ Time Frame: 12-weeks post Intra-articular Injection ]
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
- KOOS Knee Symptoms Subscale [ Time Frame: 6,12, 26, 39 & 52 weeks from Baseline versus Saline ]Change from Baseline as a result of the intervention on joint symptoms
- KOOS Knee Pain Subscale [ Time Frame: 6,12, 26, 39 & 52 weeks from Baseline versus Saline ]Change from Baseline as a result of the intervention on Knee Pain
- KOOS Physical Function Subscale [ Time Frame: 6,12, 26, 39 & 52 weeks from Baseline versus Saline ]Change from Baseline as a result of the intervention on Physical Function
- KOOS Sports and Recreation Subscale [ Time Frame: 6,12, 26, 39 & 52 weeks from Baseline versus Saline ]Change from Baseline as a result of the intervention on Sports and Recreation activities
- KOOS Quality of Life Subscale [ Time Frame: 6,12, 26, 39 & 52 weeks from Baseline versus Saline ]Change from Baseline as a result of the intervention on joint-specific Quality of Life
- Patient Global Impression of Change Questionnaire [ Time Frame: 12, 26, 39 & 52 weeks from Baseline versus Saline ]Change from Baseline as a result of the intervention on patient reported Global Impression of Change
- Overall Change in Pain Relief Medication Use from Baseline [ Time Frame: Over the 52 weeks from Baseline versus Saline ]Change in time to and frequency of use of pain relief medications and intra-articular injection of steroids and/or HA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 35 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05079035
United States, Alabama | |
UAB Orthopaedic Surgery | |
Birmingham, Alabama, United States, 35205 | |
Alabama Orthopaedic Center | |
Birmingham, Alabama, United States, 35243 | |
United States, Arizona | |
Tuscon Orthopedic Institute | |
Tucson, Arizona, United States, 85712 | |
United States, California | |
Horizon Clinical Research | |
La Mesa, California, United States, 91942 | |
United States, Florida | |
Gulfcoast Research Institute | |
Sarasota, Florida, United States, 34232 | |
Precision Clinical Research | |
Sunrise, Florida, United States, 33351 | |
United States, Georgia | |
Paragon Sports Medicine | |
Atlanta, Georgia, United States, 30327 | |
United States, Louisiana | |
Ochsner Health Center | |
Jefferson, Louisiana, United States, 70121 | |
United States, Ohio | |
Manage Sites/The Ohio State University Wexner Medical Center, Sports Medicine The Ohio State University Wexner Medical Center, Sports Medicine | |
Columbus, Ohio, United States, 43201 | |
United States, Pennsylvania | |
Rothman Orthopaedic Institute | |
Media, Pennsylvania, United States, 19063 |
Responsible Party: | Tissue Tech Inc. |
ClinicalTrials.gov Identifier: | NCT05079035 |
Other Study ID Numbers: |
TTAX03-CR005 |
First Posted: | October 15, 2021 Key Record Dates |
Last Update Posted: | April 10, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |