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

NCT05079035 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: TTAX03-CR005
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Knee Osteoarthritis; Knee Pain Chronic; Knee Arthritis

Outcome Measures

Primary Outcomes (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

  12-weeks post Intra-articular Injection

Secondary Outcomes (7)

• KOOS Knee Symptoms Subscale

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

• KOOS Knee Pain Subscale

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

• KOOS Physical Function Subscale

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

• KOOS Sports and Recreation Subscale

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

• KOOS Quality of Life Subscale

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

Study Arms (2)

Experimental: TTAX03

EXPERIMENTAL

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.

Biological: TTAX03

Control: Saline

PLACEBO COMPARATOR

2.0mL of sterile, preservative free 0.9% NaCl alone

Biological: Saline

Interventions

TTAX03 BIOLOGICAL

Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord

Experimental: TTAX03

Saline BIOLOGICAL

2 mL Sterile, preservative free 0.9% NaCl

Control: Saline

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BioTissue Holdings, Inc: lead

Study Sites (10)

UAB Orthopaedic Surgery

Birmingham, Alabama, 35205, United States

Location

Alabama Orthopaedic Center

Birmingham, Alabama, 35243, United States

Location

Tuscon Orthopedic Institute

Tucson, Arizona, 85712, United States

Location

Horizon Clinical Research

La Mesa, California, 91942, United States

Location

Gulfcoast Research Institute

Sarasota, Florida, 34232, United States

Location

Precision Clinical Research

Sunrise, Florida, 33351, United States

Location

Paragon Sports Medicine

Atlanta, Georgia, 30327, United States

Location

Ochsner Health Center

Jefferson, Louisiana, 70121, United States

Location

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

Columbus, Ohio, 43201, United States

Location

Rothman Orthopaedic Institute

Media, Pennsylvania, 19063, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 15, 2021
• Study Start: December 6, 2021
• Primary Completion: March 7, 2025
• Study Completion: March 7, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)