A clinical study to evaluate the efficacy and safety of MegaCarti® as a treatment for cartilage regeneration in patients with knee joint cartilage injury : Multicenter, microfracture control, randomization, superiority clinical trial

Not Applicable

• Conditions: Injury, poisoning and certain other consequences of external causes

• Registration Number: KCT0008226
• Lead Sponsor: &C BIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

All subjects can participate in the clinical trial only when all of the following criteria are met.
? 51 years to 65 years
? Subject or legal representatives who voluntarily decide to participate in the clinical trial and give written consent after hearing a detailed explanation of this clinical trial and fully understanding it
? Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage
? Subject whose primary lesion site can be designated as one section of the knee joint, and the area can be determined as the main cause of clinical symptoms
? Knee cartilage defect size : below 10cm2
? Subject who need concurrent Misalignment correction osteotomy(Subject who perform high tibial osteotomy due to varus deformity above -5 degrees in Hip-knee-ankle angle)

Exclusion Criteria

If any of the following items apply, the subject is excluded from the clinical trial.
?Subject who have autoimmune disease (Ex. Rheumatoid arthritis)
?When screening, Subject who have had trauma or cartilage damage or have undergone ligament surgery in the same knee as the surgical site within the past 1 year
?When screening, Subject who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy in the same knee joint as the surgical site within the past year (Possible for arthroscopy for diagnostic purposes)
?When screening, Subject who received intra-articular hyaluronic acid or steroid injection in the same knee as the surgical site within 2 months
?When screening, Subject who took oral steroids within 1 month
?Subject taking immunosuppressive drugs or immune disorder
?Subject with a history of cancer within the past 5 years
?BMI index : 35kg/m2 or more
?Subject with have gout or gout history in the same knee as the surgical site
?Subject who are pregnant, lactating or unable to use contraception
?Drug and alcohol addiction / dependence or mental disorder
?Subject with risk factor for bleeding (subject taking antithrombotic drugs other than aspirin)
?Subject who have localized knee infection in the same knee as the surgical site
?Subject who are judged by medical investigator to be considered unsuitable for this clinical trial

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score of KOOS(Knee injury and Osteoarthritis Outcome Score)

Secondary Outcome Measures

Name	Time	Method
KOOS (Knee injury and Osteoarthritis Outcome Score);WOMAC (Western Ontario & McMaster Universities);VAS (Visual Analogue Scale);Evaluation of cartilage regeneration