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Knee OsteoarthritisPhase 2NCT05079035

Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord (TTAX03) for KL Grade 3-4 Knee OA

A Phase 2 study testing TTAX03 and Saline in people with Knee Osteoarthritis and Knee Pain Chronic, run by BioTissue Holdings, Inc at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 35 to 85 years
What is being tested?
TTAX03 and Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
10 sitesUnited States
Study dates
6 Dec 2021to 7 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Paragon Sports Medicine

    Atlanta, Georgia, 30327

  • UAB Orthopaedic Surgery

    Birmingham, Alabama, 35205

  • Alabama Orthopaedic Center

    Birmingham, Alabama, 35243

  • Manage Sites/The Ohio State University Wexner Medical Center, Sports Medicine The Ohio State University Wexner Medical Center, Sports Medicine

    Columbus, Ohio, 43201

  • Ochsner Health Center

    Jefferson, Louisiana, 70121

  • Horizon Clinical Research

    La Mesa, California, 91942

  • Rothman Orthopaedic Institute

    Media, Pennsylvania, 19063

  • Gulfcoast Research Institute

    Sarasota, Florida, 34232

  • Precision Clinical Research

    Sunrise, Florida, 33351

  • Tuscon Orthopedic Institute

    Tucson, Arizona, 85712

Other trials in United States

About this study

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

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.

Read the detailed description

This trial is designed as a Phase 2 randomized, placebo controlled, double-blinded parallel design to be conducted at multiple sites throughout North America. One dose level of TTAX03 (100 mg) will be tested against an equal volume of saline, which is the suspension vehicle (i.e., excipient). Each subject will receive a single IA injection into the knee under local anesthesia, with two safety follow-up visits in the first eight days and a third at the end of two weeks post injection. Subsequent visits will occur at the end of 6 and 12 weeks for evaluation of response, with the end of 12 weeks being the primary endpoint. Additional visits will occur at 6, 9 and 12 months (end of weeks 26, 39, 52) to evaluate duration of benefit and overall impression of change from baseline, as well as safety. The primary endpoint will be assessed at 12 weeks post receiving the assigned Intra-articular injection.

Being tested
TTAX03, Saline
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TTAX03Biological

    Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord

  • SalineBiological

    2 mL Sterile, preservative free 0.9% NaCl

Study groups in NCT05079035
Study groupRoleWhat they receive
Experimental: TTAX03ExperimentalTTAX03 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.
Receives: Biological: TTAX03
Control: SalinePlacebo comparator2.0mL of sterile, preservative free 0.9% NaCl alone
Receives: Biological: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12-weeks post Intra-articular Injection

Secondary outcomes (7)

  1. KOOS Knee Symptoms Subscale

    Change from Baseline as a result of the intervention on joint symptoms

    Measured: 6,12, 26, 39 & 52 weeks from Baseline versus Saline

  2. KOOS Knee Pain Subscale

    Change from Baseline as a result of the intervention on Knee Pain

    Measured: 6,12, 26, 39 & 52 weeks from Baseline versus Saline

  3. KOOS Physical Function Subscale

    Change from Baseline as a result of the intervention on Physical Function

    Measured: 6,12, 26, 39 & 52 weeks from Baseline versus Saline

  4. KOOS Sports and Recreation Subscale

    Change from Baseline as a result of the intervention on Sports and Recreation activities

    Measured: 6,12, 26, 39 & 52 weeks from Baseline versus Saline

  5. KOOS Quality of Life Subscale

    Change from Baseline as a result of the intervention on joint-specific Quality of Life

    Measured: 6,12, 26, 39 & 52 weeks from Baseline versus Saline

  6. Patient Global Impression of Change Questionnaire

    Change from Baseline as a result of the intervention on patient reported Global Impression of Change

    Measured: 12, 26, 39 & 52 weeks from Baseline versus Saline

  7. 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

    Measured: Over the 52 weeks from Baseline versus Saline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study start6 Dec 2021
  3. Primary completion7 Mar 2025
  4. Study completion7 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079035
Sponsor's protocol ID
TTAX03-CR005
Status last verified
Sep 2025
First submitted
22 Sep 2021
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TTAX03 and Saline in people with Knee Osteoarthritis and Knee Pain Chronic, run by BioTissue Holdings, Inc at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Relief and/or Functional Improvement (time frame: 12-weeks post Intra-articular Injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05079035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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