Study to Assess the Efficacy and Safety of Treatment of Articular Cartilage Lesions With CartiLife®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-03

Study Completion Date

2017-02-23

Brief Summary

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The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocyte (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using MRI, clinical, biochemical and International Knee Documentation Committee(IKDC) outcomes preoperatively as well as 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.

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Detailed Description

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Conditions

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Articular Cartilage Lesion of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Biological: CartiLife® Procedure: CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted in a volume of 1 cm3 per the capacity of the syringe to the affected area through injection along with a fibrin adhesive through minimal arthrotomy.

Active comparator: Microfracture The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage. Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CartiLife®

Group Type EXPERIMENTAL

CartiLife®

Intervention Type DRUG

CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted the volume of 1 cm3 per the capacity of the syringe to the affected area through injection with fibrin adhesive through minimal arthrotomy.

Microfracture

Group Type ACTIVE_COMPARATOR

Microfracture

Intervention Type PROCEDURE

The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage. Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate.

Interventions

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CartiLife®

CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted the volume of 1 cm3 per the capacity of the syringe to the affected area through injection with fibrin adhesive through minimal arthrotomy.

Intervention Type DRUG

Microfracture

The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage. Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult men and women aged between 19 and 65
* Defect size: 2 to 10 ㎠ on the unilateral knee cartilage (up to 4 ㎤ in volume)
* Defect: isolated International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on articular cartilage
* The joint space is maintained over 50% relative to baseline
* Patients that are able to walk without aid
* Patients that agree to abide by strict rehabilitation protocols and follow-up programs
* Patients who provide written consent to the participation of the clinical trial

Exclusion Criteria

* Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis
* Kellgren and Lawrence grade ≥ 3
* Patients with arthritis associated with autoimmune diseases
* Patients hypersensitive to bovine protein
* Patients with Haemophilia or markedly reduced immune function
* Patients hypersensitive to antibiotics like gentamicin
* Patients with arterial bleeding and severe venous bleeding
* Patients with other diseases including tumors except for cartilaginous defects of joints
* Patients with a history of radiation treatment and chemotherapy within the past two years
* Patients who are pregnant, nursing a baby or likely to get pregnant
* Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration
* Other cases where the investigator deems the patient ineligible for participation

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No