Study to assess the efficacy and safety of treatment of articular cartilage lesions with CartiLife®.

A Multi-Center, Active-Controlled, Open-Label, Phase ? Trial to Compare the Efficacy and Safety for Treatment of Autologous Chondrocytes Implantation with CartiLife versus Microfracture for Patient with Chondral Defects in the Knee

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0001577

Enrollment

Registered

2015-07-23

Start date

2014-02-03

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell, Procedure/Surgery : Biological: CartiLife® Procedure: CartiLife® is pellets (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult males and females aged over 19 and under 65 2) Defect size: 2 to 10 ? on the unilateral knee cartilage (up to 4 ? in volume) 3) Defect: isolated International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on articular cartilage 4) The joint space is maintained over 50% relative to baseline 5) Patients with self-reliant behavior 6) Patients understand strict rehabilitation protocol and follow-up program and are willing to follow it. 7) Patients who consented to the clinical trial

Exclusion criteria

Exclusion criteria: 1) Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis 2) kellgren and Lawrence grade = 3 3) Patients with arthritis associated with autoimmune diseases 4) Patients hypersensitive to bovine protein 5) Patients with Haemophilia or markedly reduced immune function 6) Patients hypersensitive to antibiotics like gentamicin 7) Patients with arterial bleeding and severe venous bleeding 8) Patients with other diseases including tumors except for cartilaginous defects of joints 9) Patients with a history of radiation treatment and chemotherapy within the past two years 10) Patients who are pregnant, nursing a baby or likely to get pregnant 11) Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration 12) The other cases of patients which doctors determine not participate in the trial

Design outcomes

Primary

Measure	Time frame
MRI(Magnetic Resonance Imaging)- MOCART(Magnetic resonance Observation of Cartilage Repair Tissue) scoring	—

Secondary

Measure	Time frame
Lysholm score;International knee documentation committee(IKDC) ;Knee Injury and Osteoarthritis Outcome Score(KOOS);100 mm Pain Visual Analogue Scale(VAS);ROM (Range of Motion);Physical examination;Adverse event;Vital signs;MRI(Magnetic Resonance Imaging)- Confirmation of Out growth	—

Countries

Korea, Republic of

Contacts

Public ContactLee Hong

Kyung Hee University Hospital

Outcome results