Articular Cartilage Lesion of the KneePhase 2NCT03545269

Study to Assess the Efficacy and Safety of Treatment of Articular Cartilage Lesions With CartiLife®

A Phase 2 study testing CartiLife® and Microfracture in people with Articular Cartilage Lesion of the Knee, run by Biosolution Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 to 65 years
Conditions the study is for: Articular Cartilage Lesion of the Knee
What is being tested?: CartiLife® and Microfracture
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 3 Feb 2014to 23 Feb 2017
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

About this study

Official title: 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.

Conditions: Articular Cartilage Lesion of the Knee
Being tested: CartiLife®, Microfracture
Keywords: Degenerative Arthritis, Autologous Chondrocyte Implantation, Cartilage defects, Cartilage lesion, Arthritis
Medical subject headings: Osteoarthritis, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CartiLife®Drug
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.
MicrofractureProcedure or surgery
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.

Study groups in NCT03545269
Study group	Role	What they receive
CartiLife®	Experimental	Not described Receives: Drug: CartiLife®
Microfracture	Active comparator	Not described Receives: Procedure: Microfracture

What is being measured

The primary outcome is the main question the study is designed to answer.

MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)
Changes in MOCART scores during each visit
Measured: Baseline to 48 weeks

Secondary outcomes (7)

Lysholm Score
Changes in Lysholm Scores during each visit
Measured: Baseline to 48 weeks
IKDC (International Knee Documentation Committee Score)
Changes in IKDC scores during each visit
Measured: Baseline to 48 weeks
KOOS (Knee injury Osteoarthritis Outcome Score)
Changes in KOOS during each visit
Measured: Baseline to 48 weeks
VAS (100 mm Pain Visual Analogue Scale)
Changes in VAS during each visit
Measured: Baseline to 48 weeks
ROM (Range Of Motion)
Changes in ROM during each visit
Measured: Baseline to 48 weeks
Adverse events
Number of adverse events
Measured: Baseline to 48 weeks
X-ray
Changes in structure during each visit
Measured: Baseline to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 201423 Feb 2017

First posted4 Jun 2018
Study start3 Feb 2014
Primary completion23 Feb 2017
Study completion23 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Articular Cartilage Lesion of the KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Biological: CartiLife® Procedure: CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted in a volume of 1 cm3 per the capacity of the syringe to the affected area through injection along with a fibrin adhesive through minimal arthrotomy. 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.
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03545269
Sponsor's protocol ID: MCTT-CTL-021
Status last verified: May 2018
First submitted: 8 Mar 2018
Last updated: 4 Jun 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Yoon KH, Lee J, Park JY. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation Versus Microfracture for the Treatment of Articular Cartilage Defects: A 5-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2024 Feb;52(2):362-367. doi: 10.1177/03635465231222797. Epub 2024 Jan 17.
PubMed 38230875
Yoon KH, Yoo JD, Choi CH, Lee J, Lee JY, Kim SG, Park JY. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation versus Microfracture for Repair of Articular Cartilage Defects: A Prospective Randomized Trial. Cartilage. 2021 Dec;13(1_suppl):1092S-1104S. doi: 10.1177/1947603520921448. Epub 2020 Jun 1.
PubMed 32476445

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
Active, not recruiting
Episealer® Knee System IDE Clinical Study
Degenerative Lesion of Articular Cartilage of Knee
RecruitingObservational study
Knee Cartilage Repair Registry
Knee Injuries, Joint Surface Knee Lesions
Not yet recruiting
Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Canada
Knee Cartilage Lesions
Recruiting
Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
Chondral Lesion of the Knee, Meniscal Injuries

All Articular Cartilage Lesion of the Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03545269
Acronym / sponsor ID: MCTT-CTL-021
Conditions: Articular Cartilage Lesion of the Knee
Keywords: Degenerative Arthritis, Autologous Chondrocyte Implantation, Cartilage defects, Cartilage lesion, Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Biosolution Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Kyunghee University Medical Center, Gangnam Severance Hospital, Severance Hospital, Ewha Womans University
Study start: 3 Feb 2014 (actual)
Primary completion: 23 Feb 2017 (actual)
Study completion: 23 Feb 2017 (actual)
First posted: 4 Jun 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Biological: CartiLife® Procedure: CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted in a volume of 1 cm3 per the capacity of the syringe to the affected area through injection along with a fibrin adhesive through minimal arthrotomy. 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.

Arm	Type	Receives
CartiLife®	Experimental	Drug: CartiLife®
Microfracture	Active comparator	Procedure: Microfracture

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Drug	CartiLife®
MicrofractureThe 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.	Procedure or surgery	Microfracture

Primary outcome

MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)
Time frame: Baseline to 48 weeks
Changes in MOCART scores during each visit

7 secondary outcomes

Lysholm Score
Time frame: Baseline to 48 weeks
IKDC (International Knee Documentation Committee Score)
Time frame: Baseline to 48 weeks
KOOS (Knee injury Osteoarthritis Outcome Score)
Time frame: Baseline to 48 weeks
VAS (100 mm Pain Visual Analogue Scale)
Time frame: Baseline to 48 weeks
ROM (Range Of Motion)
Time frame: Baseline to 48 weeks
Adverse events
Time frame: Baseline to 48 weeks
X-ray
Time frame: Baseline to 48 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
Derived from this study: PubMed 38230875Yoon KH, Lee J, Park JY. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation Versus Microfracture for the Treatment of Articular Cartilage Defects: A 5-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2024 Feb;52(2):362-367. doi: 10.1177/03635465231222797. Epub 2024 Jan 17.
Derived from this study: PubMed 32476445Yoon KH, Yoo JD, Choi CH, Lee J, Lee JY, Kim SG, Park JY. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation versus Microfracture for Repair of Articular Cartilage Defects: A Prospective Randomized Trial. Cartilage. 2021 Dec;13(1_suppl):1092S-1104S. doi: 10.1177/1947603520921448. Epub 2020 Jun 1.
Individual participant dataSharing planned: Undecided

Related trials for Articular Cartilage Lesion of the Knee

Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
Active, not recruiting
Episealer® Knee System IDE Clinical Study
Degenerative Lesion of Articular Cartilage of Knee
RecruitingObservational study
Knee Cartilage Repair Registry
Knee Injuries, Joint Surface Knee Lesions
Not yet recruiting
Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Canada
Knee Cartilage Lesions
Recruiting
Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
Chondral Lesion of the Knee, Meniscal Injuries

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kyoung Ho, MD, PhD principal investigator

Kyunghee University Medical Center

Jong Hyeok Choi, MD, PhD principal investigator

Severance Hospital

Jae-Doo Yoo, MD, PhD principal investigator

Ewha Womans University Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CartiLife® and Microfracture in people with Articular Cartilage Lesion of the Knee, run by Biosolution Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) (time frame: Baseline to 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03545269, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.