Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect

Summary

This is a long term follow-up study to investigate the safety and efficacy of CARTISTEM®, human umbilical cord blood-derived mesenchymal stem cells, in repair of cartilage injury or defects, compared with microfracture. Subjects who participated in and completed the Phase III trial (NCT01041001) will be tracked until the 60 month post-treatment timepoint.

Conditions

• Degenerative Osteoarthritis
• Defect of Articular Cartilage

Interventions

BIOLOGICAL

CARTISTEM

A single dose of 500㎕/㎠ of cartilage defect

PROCEDURE

Microfracture

Active control

Sponsors & Collaborators

• Dong-A Pharmaceutical Co., Ltd.

  collaborator INDUSTRY

• Medipost Co Ltd.

  lead INDUSTRY

Principal Investigators

• Hong-chul Lim, MD, PhD · Korea University Guro Hospital

• Beom-gu Lee, MD, PhD · Gachon University Gil Medical Center

• Jong-hyeok Choi, MD, PhD · Gangnam Severance Hospital

• Hwa-jae Jeong, MD, PhD · Kangbuk Samsung Hospital

• Chul-won Ha, MD, PhD · Samsung Medical Center

• Jung-ro Yoon, MD, PhD · Seoul Veterans Hospital

• Seong-il Bin, MD, PhD · Asan Medical Center

• Jae-doo Yoo, MD, PhD · Ewha Womans Mokdong Hospital

• Myung-ku Kim, MD, PhD · Inha University Hospital

• Choong-hyuk Choi, MD, PhD · Hanyang University

• Young-Chul Yoon, MD, PhD · Samsung Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2015-05-31

Completion

2015-05-31

Countries

• South Korea

Study Locations