Phase 3 Clinical Trial of CartiLife® in Korea

Biosolution

Status and phase: Active, not recruiting; Phase 3

Conditions: Articular Cartilage Degeneration; Articular Cartilage Defect

Treatments: Drug: Autologous Chondrocyte Implantation (CartiLife®); Procedure: Microfracture Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT05051332

BS-CTL-III

Details and patient eligibility

About

To evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) obtained by cultivating costal chondrocytes of the subject implanted into articular cartilage defects of the knee resulting from trauma or degeneration.

Full description

This open-label, phase 3 study is being conducted to evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) compared with microfracture surgery in adults with articular cartilage defects due to trauma or degeneration of the knee. It is hypothesized that CartiLife® treatment will demonstrate structural regeneration and improvement in function and pain at Week 48 compared to baseline.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following:

1. Patients over the age of 18.
2. Defect size: 2 to 10 cm^2 on the unilateral knee cartilage (up to 4 ㎤ in volume).
3. Defect: isolated ICRS (International Cartilage Repair Society) grade III or IV single defect chondral lesion on articular cartilage with comparatively healthy cartilage present near the lesion site (ICRS Grade 1 ~ 2).
4. Patients with a KOOS total score below 55.
5. Patients able to walk without aid.
6. Patients who agree to abide by rehabilitation protocols and follow-up programs, including residential exercise routines.
7. Patients who provide written consent to the application of the clinical trial.

Exclusion criteria

Individuals who meet any of the following will be excluded from participation in this study:

1. Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis.
2. Patients scoring 3 or above on the Kellgren-Lawrence Grading Scale.
3. Patients with inflammatory articular diseases related to autoimmune diseases.
4. Patients hypersensitive to bovine derived proteins or any of the components in this product.
5. Patients hypersensitive to Gentamycin.
6. Patients with Haemophilia or markedly reduced immune function.
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, or nursing a baby.
11. Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration.
12. Other cases where the investigator deems the patient ineligible for participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

CartiLife®

Experimental group

Description:

Extracellular matrix-associated autologous chondrocytes comprise CartiLife®, composed as pellets (1.1 to 1.8 mm in diameter) in suspension. One pre-filled syringe is implanted per 1 cm\^3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy.

Treatment:

Drug: Autologous Chondrocyte Implantation (CartiLife®)

Microfracture Surgery

Active Comparator group

Description:

Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate.

Treatment:

Procedure: Microfracture Surgery