Active, Not Recruiting

NCT Number: NCT05440370

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Health Insurance Service Ilsan Hospital, Goyang-si, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

19 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 ㎠

Exclusion criteria

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
Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial
Patients who participated in other clinical trials within three months before screening

Treatment and study plan

MegaCarti®

Device

MegaCarti® application after microfracture through athroscopic or incision surgery

Microfracture

Procedure

Microfracture through athroscopic or incision surgery

Primary outcomes

MOCART score

Time frame: 48 weeks after surgery

Primary Endpoint [experimental group / control group]

Secondary outcomes

Comparison of IKDC score

Time frame: Baseline and 12, 24, 48 weeks after surgery

Secondary Endpoint [experimental group / control group]
Comparison of VAS score

Time frame: Baseline and 6, 12, 24, 48 weeks after surgery

Secondary Endpoint [experimental group / control group]
Comparison of KOOS score

Time frame: Baseline and 12, 24, 48 weeks after surgery

Secondary Endpoint [experimental group / control group]
Comparison of WOMAC score

Time frame: Baseline and 12, 24, 48 weeks after surgery

Secondary Endpoint [experimental group / control group]
Comparison of Kellgren-Lawrence grade

Time frame: Baseline and 12, 24, 48 weeks after surgery

Secondary Endpoint [experimental group / control group]
Frequency of rescue medication

Time frame: For 48 weeks after surgery

Secondary Endpoint [experimental group / control group]

Sponsors and collaborators

Lead sponsor

L&C Bio

Industry

Registry information

Official study title

Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® ; Cartilage Defect Treatment Assisting Cartilage Regeneration in Knee Cartilage Defects : Multicenter, Independent Evaluator and Subject Blinded, Microfracture Comparative, Superiority, Randomized, Confirmatory Clinical Study and 5 Years Follow up Study

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2027
First posted: Jun 30, 2022
Registry last updated: Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed