Phase 3 Clinical Trial of CartiLife® in Korea

PHASE3UnknownINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

March 19, 2020

Primary Completion Date

September 30, 2023

Study Completion Date

September 30, 2024

Conditions
Articular Cartilage DefectArticular 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

Trial Locations (18)

11765

The Catholic UNIV. of Korea Uijeongbu St. Mary's Hospital, Uijeongbu-si

13620

Seoul National University Bundang Hospital (1), Seongnam-si

Seoul National University Bundang Hospital (2), Seongnam-si

16591

The Catholic UNIV. of Korea Seoul St. Mary's Hospital, Seoul

35015

Chungnam National University Hospital, Daejeon

Pusan National University Hospital, Pusan

48108

Inje University Haeundae Paik Hospital, Busan

49267

Kosin University Gospel Hospital, Busan

58128

Chonnam National University Hwasun Hospital, Gwangju

61453

Chosun University Hospital, Gwangju

02447

Kyung Hee University Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Seoul

05278

Kyung Hee University Hospital at Gangdong, Seoul

06230

Gangnam Severance Hospital, Seoul

06351

Samsung Medical Center, Seoul

07985

Ewha Womans University Mokdong Hospital, Seoul

08308

Korea University Guro Hospital, Seoul

Sponsors
All Listed Sponsors
lead

Biosolution Co., Ltd.

INDUSTRY