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

NCT05440370 | Active Not Recruiting

• 1 other identifier: LNC-MECA-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief Summary

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. The MegaCarti® is applied after Microfracture treatment on patients with Knee Cartilage Defects. The cartilage regeneration, which is a primary endpoint, is compared to the Microfracture group through MOCART evaluation. In addition, the improvement of pain and the recovery of Normal Range of motion are compared to the Microfracture group through secondary endpoints. Then, long-term follow-up study for 5 years is conducted to the experimental group.

Conditions

Osteoarthritis, Knee

Keywords

Knee Cartilage Defects; microfracture; MegaCarti; cartilage regeneration

Outcome Measures

Primary Outcomes (1)

• MOCART score

  Primary Endpoint \[experimental group / control group\]

  48 weeks after surgery

Secondary Outcomes (6)

• Comparison of IKDC score

  Baseline and 12, 24, 48 weeks after surgery

• Comparison of VAS score

  Baseline and 6, 12, 24, 48 weeks after surgery

• Comparison of KOOS score

  Baseline and 12, 24, 48 weeks after surgery

• Comparison of WOMAC score

  Baseline and 12, 24, 48 weeks after surgery

• Comparison of Kellgren-Lawrence grade

  Baseline and 12, 24, 48 weeks after surgery

Study Arms (2)

MegaCarti® application after microfracture

EXPERIMENTAL

The experimental group is applied with MegaCarti® after microfracture. Afterwards, they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires. Long-term follow-up Study is performed to subject that completes 48-week visit, at every 6 months for 5 years.

Device: MegaCarti®; Procedure: Microfracture

Microfracture only

ACTIVE COMPARATOR

The control group undergoes microfracture and they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires.

Procedure: Microfracture

Interventions

MegaCarti® DEVICE

MegaCarti® application after microfracture through athroscopic or incision surgery

MegaCarti® application after microfracture

Microfracture PROCEDURE

Microfracture through athroscopic or incision surgery

MegaCarti® application after microfracture; Microfracture only

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years to 65 years
• Patients or legal representatives who voluntarily decide to participate in the clinical trial, after which sign the consent form.
• Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage
• Patients 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 10 ㎠

You may not qualify if:

• Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
• Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (Possible for HTO surgery)
• When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 3 months
• When screening, Patients who took oral steroid within 1 month
• When screening, Patients who have clinically significant abnormalities in blood, serum, or urine tests
• Patients taking immunosuppressive drug, or having immune disorder
• Patients who can't take MRI scan
• Patients with a history of cancer within the past five years
• Patients who have chronic renal failure, active hepatitis, or poor blood sugar control
• BMI index : 30 ㎏/㎡ or over
• Patients who have gout or gout history in the knee
• When screening, Women who are pregnant or breast-feeding, or women who are planning for pregnancy during the clinical trial, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception.
• Drug and alcohol addiction / dependence or mental disorder
• Patients with risk factor for bleeding (Patients taking antithrombotic drugs other than aspirin)
• Patients who have systemic or localized knee infection

Sponsors & Collaborators

• L&C Bio: lead

Study Sites (4)

National Health Insurance Service Ilsan Hospital

Goyang-si, Gyeonggi-do, 10444, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

Location

Yonsei University Health System, Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Seong Hwan Kim, Professor

  Yonsei University Health System, Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: April 16, 2020
• Primary Completion: June 10, 2022
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)