Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti^® in Knee Cartilage Defects

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Description

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

Targeted Conditions

Study Overview

Start Date
January 22, 2024
Completion Date
April 30, 2025
Enrollment
60
Date Posted
February 8, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Chung-Ang University Gwangmyeong Hospital
Gyeonggi-do 14353, Korea, Republic of

Ajou University Medical Center
Gyeonggi-do 16499, Korea, Republic of

Konkuk University Medical Center
Seoul 05030, Korea, Republic of

Yonsei University Health System, Gangnam Severance Hospital
Seoul 06273, Korea, Republic of

Eligibility

Minimum Age (years)
50
Maximum Age (years)
65
Eligibility Criteria
Inclusion Criteria:

50 years to 65 yaers
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
Subjects with localized full-thickness cartilage defects in the knee joint, International Cartilage Repair Society(ICRS) Grade III or IV
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
knee cartilage defect size :1.5cm^2 to 10cm^2

Exclusion Criteria:

Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
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)
When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 1 month
When screening, Patients who took oral steroid within 2 weeks
Patients who can't take MRI scan
BMI index : 30kg/m^2 or over
Patients who have gout or gout history in the knee
Women who are pregnant or breast-feeding, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception.
Patients with risk factor for bleeding
Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial

Study Contact Info

Study Contact Name
Yongbum Park; Yongbum Park, Professor; Junyoung Chung; Junyoung Chung, Professor; Junkyu Lee; Junkyu Lee, Professor; Sunghwan Kim; Seong Hwan Kim, Professor

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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.
NCTid (if applicable)
NCT06249828