Clinical trial of selective treatment of EVA-001 in patients allocated to the hyaluronic acid group after completion of EVA-001-02 study

JRCT ID: jRCT2053240149

Registered date:07/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Osteoarthritis of the knee
• Date of first enrollment: 18/06/2024
• Target sample size: 65
• Study type: Interventional
• Intervention(s): Implantation of EVA-001 into cartilage defect

Outcome(s)

• Primary Outcome: Incidence of adverse events (including laboratory abnormalities)

Secondary Outcome

1) Change from baseline in WOMAC scale at 52 weeks post-treatment
2) Change from baseline in 100 mm VAS value at 52 weeks post-treatment
3) Change from baseline in IKDC score at 52 weeks post-treatment
4) Change from baseline in each WOMAC subscale (pain, physical function and stiffness) at 52 weeks post-treatment.
5) Change from baseline in KOOS scale at 52 weeks post-treatment
6) Treatment Failure rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria at baseline will be included.
1) Patients who participated in the EVA-001-02 study, were allocated to the hyaluronic acid control group and completed Visit 8.
2) Men and women aged between 20 and 80 years at the time of obtaining consent.
3) Patients with 2-9 cm2 of lesion damage area that is the main cause of their clinical symptoms
4) For women of childbearing potential, patients who agree to maintain contraceptive status for the duration of the study
5) Patients who have voluntarily decided to participate in the trial and have signed the consent form

Exclude criteria

Patients who meet any of the following criteria shall be excluded.
1) Patients with osteoarthritis of the knee with K&L Grade 1 or 4 on simple radiographic examination
2) Patients with an FTA of less than 174 and more than 180
3) Patients with autoimmune diseases or a history of autoimmune diseases
4) Patients with infections requiring parenteral antibiotics or suspected of having such infections
5) Patients with serious cardiovascular disease (myocardial infarction, congestive heart failure, uncontrolled hypertension, or other serious cardiac disease) or a history of such disease
6) Patients with gout or suspected gout
7) Patients with blood clotting abnormalities
8) Patients with serious renal function abnormalities
9) Patients with serious liver damage
10) Patients with serious medical conditions
11) Patients with malignancy or suspected malignancy
12) Patients who are pregnant or currently breastfeeding
13) Patients who have received intra-articular drugs such as hyaluronic acid injections within the past 8 weeks
14) Patients with mental disorders or a history of mental disorders
15) Patients who are habitual drinkers and are dependent or suspected of being alcoholic
16) Patients with nicotine dependence or suspected nicotine dependence
17) Patients with chronic inflammatory joint diseases (e.g., rheumatoid arthriis)
18) Patients who have received immunosuppressive drugs such as cyclosporine A or azathioprine within the past 6 weeks
19) Patients with injuries to the anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and lateral collateral ligament of the knee to be transplanted with mobility.
20) Patients who are scheduled to undergo surgical treatment of the target knee joint, such as treatment for meniscus injury or ligament reconstruction, or who have undergone such surgical treatment within the past 6 months.
21) Patients with paralysis due to nerve or muscle disease on the side of the knee joint cartilage damage or defect (affected side of the leg)
22) Patients with a partial arthroplasty in the knee to be transplanted.
23) Patients with a history of serious hypersensitivity to bovine-derived or porcine-derived ingredients of this product
24) Patients with a history of severe hypersensitivity or anaphylactic shock to gentamicin
25) Patients with a history of severe hypersensitivity or anaphylaxis to sodium hyaluronate or products containing hyaluronate ity or anaphylactic shock to gentamicin
26) Patients with a history of transplantation or multiple blood transfusion
27) Patients who participated in a clinical trial other than the EVA-001-02 trial within the last three months
28) Patients who have been at rest for a long period of time within the past 3 months
29) Patients with a history of contraindications for cartilage magnetic resonance imaging (MRI) or contrast media if contrast media is used.
30) Other patients deemed unfit by the (sub)investigator, taking into account the assessment of safety and efficacy (e.g. subjective judgement).

Related Information

• Primary Sponsor: Lee Antonio