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

A multi-center, Open-label, Phase I trial to assess the safety for treatment of autologous chondrocytes implantation with CartiLife for patients with chondral defects in the knee

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000560

Enrollment

Registered

2012-10-15

Start date

2012-07-17

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

Drug, Procedure/Surgery : Biological: CartiLife® Procedure: CartiLife® is pellets (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The pellets are implanted the volu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult males and females aged over 19 2) Defect size: 2 to 10 ? on the unilateral knee cartilage (up to 4 ? in volume) 3) Defect: isolated 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) Subjects who consented to the clinical trial or on whose behalf a person with parental rights consented to the clinical trial

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety (Vital signs, Physical examnination, Laboratory test, Immunoassay);Adverse event;Efficacy (IKDC, X-ray)	—

Secondary

Measure	Time frame
Safety (Vital signs, Physical examnination)	—

Countries

Korea, Republic of

Contacts

Public ContactSang Lee

Seoul National University Hospital

Outcome results