Study to Assess the 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

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-17

Study Completion Date

2013-12-10

Brief Summary

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The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocytes (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using clinical, biochemical and IKDC (International Knee Documentation Committee) outcomes preoperatively as well as 4, 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 Knee

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CartiLife (low-dose group)

Total defect volume in low-dose group is less than 2 ㎤. Low- and high-dose group are sequentially processed.

Group Type EXPERIMENTAL

CartiLife

Intervention Type DRUG

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 with a fibrin adhesive through minimal arthrotomy.

CartiLife (high-dose group)

Total defect volume in High-dose group is 2 \~ 4 ㎤.

Group Type EXPERIMENTAL

CartiLife

Intervention Type DRUG

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 with a fibrin adhesive through minimal arthrotomy.

Interventions

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CartiLife

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 with a fibrin adhesive through minimal arthrotomy.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients at least 19 years old
* Defect size: 2 to 10 ㎠ on the unilateral knee cartilage (up to 4 ㎤ in volume)
* Defect: isolated ICRS (International Cartilage Repair Society) 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
* Patients with arthritis associated with autoimmune disease
* Patients hypersensitive to bovine protein
* Patients with Haemophilia or markedly reduced immune function
* Patients hypersensitive to antibiotics such as 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No