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TTAX03 Injection for Knee Osteoarthritis
Phase 2
Waitlist Available
Research Sponsored by Tissue Tech 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6,12, 26, 39 & 52 weeks from baseline versus saline
Awards & highlights
Study Summary
This trial is testing whether a medication injected into the knee joint can improve symptoms more than just injecting salt water.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Select...
My liver tests are within normal limits.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain Relief and/or Functional Improvement
Secondary outcome measures
KOOS Knee Pain Subscale
KOOS Knee Symptoms Subscale
KOOS Physical Function Subscale
+4 moreTrial 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
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Who is running the clinical trial?
Tissue Tech Inc.Lead Sponsor
15 Previous Clinical Trials
848 Total Patients Enrolled
1 Trials studying Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 35 and 85 years old, or over 50 if 30 younger participants have already joined.I've had a knee injury in the last 3 months that made it hard to walk for over a day.I am willing to use effective birth control during the study.I haven't found relief from joint pain with specific treatments for over 3 months.I have had surgery on my knee for ligament repair or bone grafting.I have severe knee pain that limits my daily activities like walking or climbing stairs.I have had radiation therapy on my knee.My knee pain score is 70 or above.I experience moderate to severe knee pain, even when resting.My blood tests show my bone marrow is working well.I haven't had knee injections or taken steroids in the last 2-3 months.I have a history of inflammatory or autoimmune joint diseases.I feel like my knee locks or has something loose inside.I have used immunosuppressive drugs, had chemotherapy, or an organ transplant.My kidney function is within normal limits.I do not have conditions like severe heart disease or other types of arthritis affecting my walking more than my knee pain does.I have had knee pain for over a year due to osteoarthritis.I cannot walk or leave my bed due to severe pain or joint disease.My knee stays swollen and painful despite rest or medication.I've tried other treatments like weight loss and physical therapy for over 3 months without enough pain relief.I have previously been treated with CLARIX FLO, NEOX FLO, or injectable birth tissue products.I had knee ligament surgery within the last year.I have psoriasis or another skin condition affecting my knee.I am scheduled for knee surgery within the next 12 weeks.I am currently using opioid painkillers or have tested positive for them recently.My liver tests are within normal limits.I don't use blood thinners (except low-dose aspirin) and don't have bleeding disorders or sickle cell disease.I might have an infection in my knee joint.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: TTAX03
- Group 2: Control: Saline
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT05079035 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment currently have vacancies?
"Indeed, this medical study is actively enrolling volunteers. It was initially advertised on December 6th 2021 and the details have been most recently revised as of October 4th 2022."
Answered by AI
Has the FDA sanctioned TTAX03 for medical usage?
"TTAX03's safety has been assessed at a 2 because to date, only preliminary data demonstrating its security have been collected. No evidence of efficacy is available yet."
Answered by AI
To what capacity is this trial accommodating new enrollees?
"Correct. Details accessible on clinicaltrials.gov confirm that this research project, originally posted on December 6th 2021, is presently enrolling patients. The team needs to recruit 90 volunteers from 7 distinct medical centres."
Answered by AI
How many sites are hosting this clinical trial?
"Presently, 7 trial sites are offering this medical intervention. Sunrise, Avon and Media serve as the primary locations with 4 other cities hosting the research too. Individuals looking to participate should prioritize selecting a local site in order to limit travel needs."
Answered by AI
Is the upper age limit for participation in this test 25 years or older?
"This medical trial is only including individuals aged between 35 and 85 years."
Answered by AI
Who qualifies to join this research initiative?
"This medical trial is seeking 90 participants aged between 35 and 85 with osteoarthritis of the knee."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
Alabama
Arizona
How old are they?
65+
What site did they apply to?
Central Research Associates, Inc.
Tuscon Orthopedic Institute
Rothman Orthopaedic Institute
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
Why did patients apply to this trial?
Osteoarthritis is a big problem for me. I had a TKR in 2016 and a revision in 2021. I had 2 falls within 3 hours on the 2nd day after surgery which resulted in torn quads. After 2 surgeries to repair the quads for the left knee/leg, I am experiencing quite a bit of pain in my right knee from compensating. Do not want to have another surgery and would like to try a less invasive protocol.
PatientReceived 1 prior treatment
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