Completed

A Multi-center, Open-label, Phase I Trial to Assess the Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife for Patients With Chondral Defects in the Knee

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What is being tested

CartiLife

Drug
Who is being recruted

Arthritis+2

+ Joint Diseases

+ Musculoskeletal Diseases

Over 19 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorBiosolution Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 17, 2012

Actual date on which the first participant was enrolled.

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.

Official TitleA Multi-center, Open-label, Phase I Trial to Assess the Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife for Patients With Chondral Defects in the Knee
NCT03517046
Principal SponsorBiosolution Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic Diseases

Criteria

7 inclusion criteria required to participate
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
Show More Criteria
11 exclusion criteria prevent from participating
Patients hypersensitive to bovine protein
Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis
Patients with arthritis associated with autoimmune disease
Patients with Haemophilia or markedly reduced immune function
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers