Clinical study on treatment for meniscal defect using collagen-based construct.

Phase 2

• Conditions: Meniscal Injury

• Registration Number: JPRN-jRCTs052180065
• Lead Sponsor: akata Ken

Brief Summary

In summary, although we had planned to enroll 35 patients in patients with meniscus injury at the beginning of the study, we subsequently enrolled 11 patients, because we decided to change strategy to get regulatory approval under from this clinical research to clinical trial. It was confirmed that we successfully obtained safety as well as primary and secondary efficacy endpoint in 11 patients with meniscus injury in the current study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-18
• Study Completion: 2020-05-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

1) Patients who are diagnosed as meniscus injury by MRI
2) Patients with drug-uncontrollable knee pain
3) Patients who are between 16 and 60 years old
4) Patients (in case a patient is between 16 and 19 years old, both the proxy and the patient) whom the researchers obtain the written consent
5) Patients who has meniscus defect more than 10 mm2 after trimming

Exclusion Criteria

1) Meniscal injury patients who need operation and treatment
2) Patients with knee osteoarthritis of Kellgren-Lawrence grade III or IV
3) Patients with allergic or atopic tendency
4) Patients with infections (positive for HIV, HBV, HCV, or HTLV)
5) Patients with active cancer
6) Pregnant or possibly pregnant patients, patients giving the breast to a child or expecting a child during the study periods
7) Psychopathic patients who are considered noncompliant, or unable to understand the significance of this study
8) Patients whom the researchers judge to be inappropriate to be enrolled in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified