Phase 3 Clinical Trial of CartiLife® in Korea

Summary

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.

Conditions

• Articular Cartilage Defect
• Articular Cartilage Degeneration

Interventions

DRUG

Autologous Chondrocyte Implantation (CartiLife®)

CartiLife consists of small beads (1 mm in diameter) in suspension, developed from pellet culture of autologous costal chondrocytes after multiplication. The beads are implanted in an injective manner with fibrin glue through minimal arthrotomy. The dose depends on the size (volume) of the defect, recommended dose is 480 pellets/cm\^3 defect

PROCEDURE

Microfracture Surgery

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

Sponsors & Collaborators

• Biosolution Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Jungsun Lee, Ph.D · Biosolution Co., Ltd.

• Kyoung Ho Yoon, MD · Kyung Hee University Hospital

• Jae Doo Yoo, MD · Ewha Womans University Mokdong Hospital

• Sang Hak Lee, MD · Kyung Hee University Hospital at Gangdong

• Sung-Hwan Kim, MD · Gangnam Severance Hospital

• Ji Hoon Bae, MD · Korea University Guro Hospital

• Hyuk-Soo Han, MD · Seoul National University Hospital

• Joon Ho Wang, MD · Samsung Medical Center

• Min Jung, MD · Severance Hospital

• Yong In, MD · The Catholic UNIV. of Korea Seoul St. Mary's Hospital

• Chong Bum Chang, MD · Seoul National University Bundang Hospital (1)

• Yong Seuk Lee, MD · Seoul National University Bundang Hospital (2)

• Seok Jung Kim, MD · The Catholic UNIV. of Korea Uijeongbu St. Mary's Hospital

• Jong Geun Seon, MD · Chonnam National University Hospital

• Dong Hwi Kim, MD · Chosun University Hospital

• Young-Mo Kim, MD · Chungnam National University Hospital

• Seung Joon Rhee, MD · Pusan National University Hospital

• Sang Won Moon, MD · Haeundae Paik Hospital, Inje University

• Young Choi, MD · Kosin University Gospel Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-19

Primary Completion

2023-09-30

Completion

2024-09-30

Countries

• South Korea

Study Locations