Clinical trial of GM181 in patients with meniscal injuries

JRCT ID: jRCT2052210018

Registered date:07/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Meniscal Injury
• Date of first enrollment: 07/05/2021
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Implantation of meniscal scaffold at defect area

Outcome(s)

Primary Outcome

Safety evaluation
Data of adverse event and clinical examination (Blood test and Blood biochemical test) on several time points

Secondary Outcome

Evaluation of efficacy
1. Evaluation of knee inflammation and meniscal repair by MRI
2. Evaluation of joint space by X-ray
3. Range of knee motion
4. Pain score (VAS)
5. Activity score by KOOS, Lysholm, IKDC and Tegner
6. Evaluation of meniscus, cartilage, and synovium at the implantation by arthroscopy

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 60age old
• Gender: Both

Include criteria

1. Patients' age: 18-60 years old
2. Meniscal injuries which are not able to be treated with suture
3. Positive McMurray test with catching, clicking and pain
4. Patients who agree with the written informed consent (If the patient who is under 20 years old, consent from the parent is also needed.)
5. Patients who did not improve the symptom with conservative treatment at other hospital over 3 months

Exclude criteria

(Preoperative criteria)
1. Patients who are prone to allergic symptoms such as bronchial asthma and urticaria
2. Obese patients (BMI is 30 kg/m2 or more : obesity is grade 2 or higher)
3. Patients who have meniscal injuries on both sides that need surgical treatment.
4. Patients who have been receiving OA treatment or K/L Grade 3 or 4 of OA
5. Patients who have lower limb malalignment which is out of 172 to 178 degrees of feorotibial angle.
6. Patients who have diseased knee by cruciate ligament dysfunction
7. Patients who had received knee ligament reconstruction or osteotomy within 6 months
8. Patients over 12,000 /microliter of WBC or 0.3 mg/dL of CRP on preoperative blood examination

(Intraoperative criteria)
1. Patient who has cartilage injury more than 1 cm2 of ICRS classification Grade 3 or 4
2. With arthroscope, in either of the following two cases,
(1) Less than 1/3 width of meniscal resection from the inner edge
(2) Suturing is applicable
3. In the remaining part after meniscal resection, in either of the following two cases,
(1) Less than 1/3 width from the outer edge of the remaining meniscus
(2) The meniscus tear reached the outer edge and failure of hoop stress
4. Patients who are judged by the principal investigator or sub-investigator to be inappropriate for this clinical trial

Related Information

• Primary Sponsor: Otsuki Shuhei