Clinical trial NCT06249828: Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti^® in Knee Cartilage Defects
Official title: A Clinical Trial to Evaluate the Efficacy and Safety of Cartilage Regeneration in the Use of MegaCarti^® in Patients with Knee Joint Cartilage Injury: Multicenter, Independent Evaluator-subject Blinded, Microfracture-comparative, Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee Cartilage Defects
Microfracture
HTO
High Tibia Osteotomy
MegaCarti
Cartilage regeneration
Lead sponsor: L&C Bio
Sponsor class: INDUSTRY
First posted: 2024-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and MegaCarti\^® will be applied.

Detailed description: The MegaCarti\^® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow.

To evaluate cartilage regeneration, the study group is compared with the microfracture group alone through MOCART evaluation at 48 weeks after treatment for cartilage regeneration. In addition, a biopsy is performed to evaluate the formation of hyaline cartilage and the area ratio of regenerated cartilage is measured.

Eligibility criteria: Inclusion Criteria:

1. 50 years to 65 yaers
2. After receiving a detailed explanation of this clinical trial and fully understanding it, the subject or legal representative voluntarily decides to participate in the clinical trial and sign the consent form
3. Subjects with localized full-thickness cartilage defects in the knee joint, International Cartilage Repair Society(ICRS) Grade III or IV
4. Subjects 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
5. knee cartilage defect size :1.5cm\^2 to 10cm\^2

Exclusion Criteria:

1. Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
2. When screening, Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (However, arthroscopy for diagnostic purposes is possible. Additionally, it is possible if hightibial osteotomy (HTO) has been performed in advance or is scheduled)
3. When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 1 month
4. When screening, Patients who took oral steroid within 2 weeks
5. Patients who can't take MRI scan
6. BMI index : 30kg/m\^2 or over
7. Patients who have gout or gout history in the knee
8. Women who are pregnant or breast-feeding, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception.
9. Patients with risk factor for bleeding
10. Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial

Primary outcomes:
measure: MOCART score
timeFrame: From 48 weeks after surgery
Secondary outcomes:
measure: IKDC score
timeFrame: Baseline and 12, 24, 48 weeks after surgery
measure: VAS
timeFrame: Baseline and 12, 24, 48 weeks after surgery
measure: KOOS
timeFrame: Baseline and 12, 24, 48 weeks after surgery
measure: ICRS-CRA score
timeFrame: From 48 weeks after surgery
measure: OAS
timeFrame: From 48 weeks after surgery
measure: Cartilage Coverage Ratio
timeFrame: From 48 weeks after surgery
measure: Histological Evaluation
timeFrame: From 48 weeks after surgery
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Medical Center
city: Incheon
country: Korea, Republic of
facility: Catholic Kwandong University International St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Sarang Hospital
Study officials:
affiliation: Yonsei University College of Medicine Gangnam severance Hospital
name: Sunghwan kim
role: STUDY_DIRECTOR
affiliation: Ajou University Medical Center
name: Junyoung Chung
role: STUDY_DIRECTOR
affiliation: Konkuk University Medical Center
name: Junkyu Lee
role: STUDY_DIRECTOR
affiliation: Chung-Ang University Gwangmyeong Hospital
name: Yongbum Park
role: STUDY_DIRECTOR
References: