Phase II Exploratory Study of EVA-001 for Osteoarthritis of the Knee (Phase II Exploratory Study of EVA-001 for Osteoarthritis of the Knee)
Phase II Exploratory Study of EVA-001 for Osteoarthritis of the Knee (Phase II Exploratory Study of EVA-001 for Osteoarthritis of the Knee)
Yamamoto Masao
EVASTEM CO., LTD.
7F, Shirokanedai STbldg, 4-7-4 Shirokanedai Minato-ku, Tokyo
+81-3-5422-6273
eva001@evastem.jp
Yamamoto Masao
EVASTEM Co., Ltd.
7F, Shirokanedai STbldg, 4-7-4 Shirokanedai Minato-ku, Tokyo
+81-3-5422-6273
eva001@evastem.jp
Suspended
June. 29, 2020
June. 29, 2020
50
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 ICRS Grade 3 or 4 cartilage damage or deficiency in the knee joint as determined by magnetic resonance imaging (MRI) during the screening phase or by examination within the past 3 months.
3)Patients with a K and L Grade of 2 to 4 based on simple x-ray examination
4)Patients with an area of lesion damage of 2-9 cm2 that is the primary source of clinical symptoms
5)Patients with knee flexion contractures of 10 degrees or less
6)Patients who are eligible for high tibial osteotomy with a femoro-tibial angle (FTA) of 180 to 185 degrees.
7)Patients with pain of 40 mm or more on the 100 mm VAS Scale
8)Patients with a BMI of 35 kg/m2 or less
9)Patients who do not wish to become pregnant during the trial period
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)no remaining lateral cartilage due to progressive osteoarthritis of the knee
2)autoimmune diseases or a history of such diseases
3)an infection or suspected infection requiring parenteral antibiotics
4)serious cardiovascular disease (myocardial infarction, congestive heart failure, uncontrolled hypertension, or other serious cardiac disease) or a history of such disease
5)gout or suspected gout
6)blood clotting abnormalities
7)serious renal function abnormalities
8)serious liver damage
9)serious medical conditions
10)malignancy or suspected malignancy
11)who are pregnant or potentially pregnant
12)who are currently breastfeeding
13)mental disorders or a history of mental disorders
14)who are habitual drinkers and are dependent or suspected of being alcoholic
15)a mean number of cigarettes smoked per day x number of years of smoking to date of 200 or more, and patients who are nicotine dependent or suspected to be so.
16)chronic inflammatory joint diseases (e.g., rheumatoid arthritis).
17)who have received immunosuppressive drugs such as cyclosporine A or azathioprine within the past 6 weeks
18)ligament fiber damage of Grade II or greater.
19)paralysis due to nerve or muscle disease on the side of the knee joint cartilage damage or defect (affected side of the leg)
20)a history of serious hypersensitivity to bovine-derived or porcine derived ingredients of this product
21)a history of severe hypersensitivity or anaphylactic shock to gentamicin
22)a history of severe hypersensitivity or anaphylactic shock to metal allergy
23)a history of severe hypersensitivity or anaphylaxis to sodium hyaluronate or products containing hyaluronic acid.
24)a history of blood transfusion or transplantation
25)who have participated in another clinical trial within the past 3 months
26)who have been at rest for a long period of time within the past 3 months
27) with a history of contraindications to magnetic resonance imaging (MRI) or contrast media
28) with meniscus locking symptoms
29) Other patients who are determined to be unsuitable by the investigator or sub-investigator
20age old over
80age old not
Both
Ostheoarthritis of the knee
Test group : Implantation of EVA-001 into cartilage defect and HTO
Control group : HTO alone
Safety, Efficacy
Primary efficacy endpoint: Percentage of improvement in ICRS grade 1 or better at 52 weeks post-treatment
Secondary efficacy endpoint:
1. Change from the baseline in the total score of pain, stiffness and physical function by the WOMAC Scale at 52 weeks post-treatment.
2. Change from the baseline in the total score of symptoms, stiffness, pain, daily living, sports and recreational activities, and quality of life by the KOOS Scale at 52 weeks post-treatment.
3. Total ICRS points at 52 weeks post-treatment.
4. Evaluation of cartilage regeneration of cartilage tissue collected in biopsies at 52 weeks post-treatment (for consenting patients only).
5. Improvement in pain score by 100 mm VAS Scale up to 52 weeks post-treatment by assessment point in time.
6. Classification of cartilage shape by magnetic resonance imaging (MRI) by time point of assessment up to 52 weeks post-treatment.
7. Improvement in K&L grade by X-ray examination by time point of assessment up to 52 weeks post-treatment.
8. Improvement in scores by IKDC score by time point of assessment up to 52 weeks post-treatment.
EVASTEM Co., Ltd.
Saitama Medical University Hospital Institutional Review Board
