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Phase-III Comparative Study of EVA-001 for Osteoarthritis of the Knee

Phase-III Comparative Study of EVA-001 for Osteoarthritis of the Knee

Lee Antonio

MEDIPOST K.K.

5F, Masumoto bldg, 1-7-6 Toranomon Minato-ku, Tokyo

eva-001-02@medi-post.co.jp

Yamazaki Kazuhiro

MEDIPOST K.K.

5F, Masumoto bldg, 1-7-6 Toranomon Minato-ku, Tokyo

+81-3-5422-6273

kazuhiro.yamazaki@medi-post.co.jp

Not Recruiting

April. 01, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

Patients who meet all of the following criteria will be included.
1) Men and women between the ages of 20 and less than 80 years
2) Patients with a K&L Grade of 2 to 3 based on simple X-ray examination
3) Patients with ICRS Grade 3 or 4 cartilage damage or deficiency in the knee joint (Determined by magnetic resonance imaging (MRI) or by examination within the past 3 months)
4) Patients with lesions of 2-9 cm2 that are the main cause of clinical symptoms
(MRI evaluation during the screening phase and Arthroscopy at Visit 3 by Principal Investigator or Sub-Investigator)
5) Patients with FTA greater than 174 degrees and less than 180 degrees
6) Patients with pain of 40 mm or more on the 100 mm VAS Scale
7) Patients with a BMI of 35 kg/m2 or less
8) Patients who have not responded to conservative therapy for more than 3 months
9) For women of childbearing potential, patients who agree to maintain contraceptive status for the duration of the study
10) Patients who have voluntarily decided to participate in the trial and have signed the consent form

Patients who meet any of the following criteria shall be excluded.
1) Patients with autoimmune diseases or a history of autoimmune diseases
2) Patients with infections requiring parenteral antibiotics or suspected of having such infections
3) Patients with serious cardiovascular disease (myocardial infarction, congestive heart failure, uncontrolled hypertension, or other serious cardiac disease) or a history of such disease
4) Patients with gout or suspected gout
5) Patients with blood clotting abnormalities
6) Patients with serious renal function abnormalities
7) Patients with serious liver damage
8) Patients with serious medical conditions
9) Patients with malignancy or suspected malignancy
10) Patients who are pregnant or currently breastfeeding
11) Patients who have received intra-articular drugs such as hyaluronic acid injections within the past 8 weeks
12) Patients with mental disorders or a history of mental disorders
13) Patients who are habitual drinkers and are dependent or suspected of being alcoholic
14) Patients with nicotine dependence or suspected nicotine dependence
15) Patients with chronic inflammatory joint diseases (e.g., rheumatoid arthritis)
16) Patients who have received immunosuppressive drugs such as cyclosporine A or azathioprine within the past 6 weeks
17) Patients with dynamic injuries to the anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, and lateral collateral ligament of the knee
18) 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.
19) 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)
20) Patients with a partial arthroplasty in the knee to be transplanted.
21) Patients with a history of serious hypersensitivity to bovine-derived or porcine-derived ingredients of this product
22) Patients with a history of severe hypersensitivity or anaphylactic shock to gentamicin
23) Patients with a history of severe hypersensitivity or anaphylaxis to sodium hyaluronate or products containing hyaluronate
24) Patients with a history of transplantation or multiple blood transfusion
25) Patients who have participated in another clinical trial within the past 3 month
26) Patients who have been at rest for a long period of time within the past 3 months
27) Patients with a history of contraindications for cartilage magnetic resonance imaging (MRI) or contrast media if contrast media is used.
28) Other patients deemed unfit by the (sub)investigator, taking into account the assessment of safety and efficacy (e.g. subjective judgement).

Both

Osteoarthritis of the knee

Test group: Implantation of EVA-001 into cartilage defect
Control group: Hyaluronic acid preparation (administered every week for 5 consecutive doses)

1) Change from baseline in the WOMAC scale at 52 weeks post-treatment
2) Percentage of improvement in ICRS grade 1 or better at 52 weeks post-treatment

1) Total ICRS points at 52 weeks post-treatment.
2) Evaluation of cartilage regeneration of cartilage tissue collected in biopsies at 52 weeks post-treatment (Histological evaluation)
3) Change from baseline in 100 mm VAS value at 52 weeks post-treatment
4) Change from baseline in IKDC score at 52 weeks post-treatment
5) Change from baseline in each WOMAC subscale (pain, physical function and stiffness) at 52 weeks post-treatment.
6) Change from baseline in KOOS scale at 52 weeks post-treatment
7) Change from baseline in whole organ magnetic resonance imaging score (WORMS) at 52 weeks post-treatment
8) Treatment Failure rate

+81-48-222-5015

Feb. 03, 2022

No

none