Study to Assess the Efficacy and Safety of Treatment of Articular Cartilage Lesions With CartiLife®
May 22, 2018 updated by: Biosolution Co., Ltd.
A Multi-Center, Active-Controlled, Open-Label, Phase Ⅱ Trial to Compare the Efficacy and Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife Versus Microfracture for Patient With Chondral Defects in the Knee
The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocyte (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee.
The patients will be assessed clinically using MRI, clinical, biochemical and International Knee Documentation Committee(IKDC) outcomes preoperatively as well as 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult men and women aged between 19 and 65
- Defect size: 2 to 10 ㎠ on the unilateral knee cartilage (up to 4 ㎤ in volume)
- Defect: isolated International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on articular cartilage
- The joint space is maintained over 50% relative to baseline
- Patients that are able to walk without aid
- Patients that agree to abide by strict rehabilitation protocols and follow-up programs
- Patients who provide written consent to the participation of the clinical trial
Exclusion Criteria:
- Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis
- Kellgren and Lawrence grade ≥ 3
- Patients with arthritis associated with autoimmune diseases
- Patients hypersensitive to bovine protein
- Patients with Haemophilia or markedly reduced immune function
- Patients hypersensitive to antibiotics like gentamicin
- Patients with arterial bleeding and severe venous bleeding
- Patients with other diseases including tumors except for cartilaginous defects of joints
- Patients with a history of radiation treatment and chemotherapy within the past two years
- Patients who are pregnant, nursing a baby or likely to get pregnant
- Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration
- Other cases where the investigator deems the patient ineligible for participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Microfracture
|
The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage.
Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate.
|
|
Experimental: CartiLife®
|
CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes.
The beads are implanted the volume of 1 cm3 per the capacity of the syringe to the affected area through injection with fibrin adhesive through minimal arthrotomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)
Time Frame: Baseline to 48 weeks
|
Changes in MOCART scores during each visit
|
Baseline to 48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lysholm Score
Time Frame: Baseline to 48 weeks
|
Changes in Lysholm Scores during each visit
|
Baseline to 48 weeks
|
|
IKDC (International Knee Documentation Committee Score)
Time Frame: Baseline to 48 weeks
|
Changes in IKDC scores during each visit
|
Baseline to 48 weeks
|
|
KOOS (Knee injury Osteoarthritis Outcome Score)
Time Frame: Baseline to 48 weeks
|
Changes in KOOS during each visit
|
Baseline to 48 weeks
|
|
VAS (100 mm Pain Visual Analogue Scale)
Time Frame: Baseline to 48 weeks
|
Changes in VAS during each visit
|
Baseline to 48 weeks
|
|
ROM (Range Of Motion)
Time Frame: Baseline to 48 weeks
|
Changes in ROM during each visit
|
Baseline to 48 weeks
|
|
Adverse events
Time Frame: Baseline to 48 weeks
|
Number of adverse events
|
Baseline to 48 weeks
|
|
X-ray
Time Frame: Baseline to 48 weeks
|
Changes in structure during each visit
|
Baseline to 48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kyoung Ho, MD, PhD, Kyunghee University Medical Center
- Principal Investigator: Jong Hyeok Choi, MD, PhD, Severance Hospital
- Principal Investigator: Jae-Doo Yoo, MD, PhD, Ewha Womans University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 3, 2014
Primary Completion (Actual)
February 23, 2017
Study Completion (Actual)
February 23, 2017
Study Registration Dates
First Submitted
March 8, 2018
First Submitted That Met QC Criteria
May 22, 2018
First Posted (Actual)
June 4, 2018
Study Record Updates
Last Update Posted (Actual)
June 4, 2018
Last Update Submitted That Met QC Criteria
May 22, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MCTT-CTL-021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.