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A clinical trial to confirm the efficacy and safety of silk-elastin (P47K-WAS-MR) for meniscal repair including avascular zone.

A clinical trial to confirm the efficacy and safety of silk-elastin (P47K-WAS-MR) for meniscal repair including avascular zone.

Kawabata Shingo

SANYO CHEMICAL INDUSTRIES, LTD.

11-1, Ikkyo Nomoto-cho, Higashiyama-ku, Kyoto 605-0995, Japan

s.kawabata@sanyo-chemical.group

Kawabata Shingo

SANYO CHEMICAL INDUSTRIES, LTD.

11-1, Ikkyo Nomoto-cho, Higashiyama-ku, Kyoto 605-0995, Japan

+81-75-541-6249

s.kawabata@sanyo-chemical.group

Recruiting

Oct. 17, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients who meet all of the following selection criteria will be considered
1) Patients who are at least 8 years old at the time of consent
2) Patients whose written consent has been obtained from the patient.
If the patient is between 8 and 18 years old, written consent must be obtained from both the patient and a surrogate (parents (or person who has parental authority over the subject), guardian, or other equivalent person).
3) Patients diagnosed on MRI images as having a meniscus injury that includes an avascular zone (2/3 of the area from the medial margin of the meniscus), either alone or in conjunction with an anterior cruciate ligament injury.
4) Patients with limited knee range of motion due to mechanical symptoms (Catching), or fitting symptoms (Locking) resulting from meniscus injury.
5) Patients whose pain does not improve despite conservative treatment with exercise therapy or analgesics.
6) Patients with an IKDC score of 55 or less

Patients who meet any of the following criteria will be excluded from the study.
1) Patients with a BMI greater than 50 kg/m 2
2) Patient underwent total meniscectomy on the affected side
3) Patients within 1 year of ligament reconstruction or osteotomy to the affected knee
4) Patients who have received an intra-articular injection into the target knee within 2 months prior to obtaining consent
5) Diagnosed with osteoarthritis of the knee Patient (K-L classification grade 3 or higher)
6) Patients with knee varus or valgus deformity of +/- 5 degrees or more compared to the normal value (FTA 175 degree)
7) Patients with a history of autoimmune arthritis (rheumatoid arthritis, etc.), sepsis, gout, pseudogout, pyogenic arthritis, or secondary arthropathy.
8) Patients diagnosed with diabetes mellitus and poor glycemic control (HbA1c > 7.8 or on insulin therapy)
9) Patients with a serious illness (any type of metastatic cancer, autoimmune disease, etc.) with a survival probability of less than 2 years.
10) Patients with a history of allergies to silk, anesthetics, or disinfectants used in this clinical trial.
11) Patients who test positive for at least one of HBs antigen, HCV antibody, or HIV antigen/antibody.
12) Patients taking the following prescription medications:
Regular use of opioid analgesics, anticoagulants, corticosteroids, growth hormone, testosterone.
13) Patients on pacemakers, neurostimulators, metal particles, stents, and clips used for implants.
14) Pregnant, nursing, or potentially pregnant patients:
Women of childbearing potential and men who cannot agree to contraception for at least one year after reconstruction surgery.
15) Patients currently participating in other clinical trials or other clinical research/studies and who have not used the last investigational drug or device within 6 months of receiving the trial.
16) Patients whose meniscus tear shape or degenerative state is deemed difficult to suture by the investigator.
17) Patients for whom the principal investigator/sub-investigator determines, based on imaging diagnostics such as MRI, that damage not targeted by the clinical trial is present in the vascular zone (peripheral 1/3).
18) Patients for whom the principal investigator/sub-investigator determines that it is difficult to attend regular examinations and that they will not be able to comply with the outpatient visits and examinations required by the clinical trial plan.
19) Other patients deemed inappropriate by the investigator/associate investigator.

Both

Meniscal injury involving avascular zone.

P47K-WAS-MR dissolved in saline is placed at the suture site when the meniscus is sutured

IKDC Score at 52 weeks:
Achievement Criteria: 69 points

1) Evaluation of IKDC Score over time
2) Incidence of reoperation up to the final observation point
3) Evaluation of the suture union status and nonunion rate at 24 weeks after surgery and at discontinuation (arthroscopy at discontinuation was performed as needed)
4) Evaluation of the suture union status and nonunion rate at each observation point and at the final observation point (52 weeks or at discontinuation) (MRI examination)
5) Change in joint space width from screening before surgery to 52 weeks after surgery and at the final observation point (52 weeks or at discontinuation)
6) Evaluation of pain over time using a VAS
7) Evaluation of quality of life over time using the Patient-Based QOL/ADL Score (KOOS) and subjective symptoms over time using the Lysholm
8) Evaluation of activity over time using the Tegner Score

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