Articular Cartilage Lesion of KneePhase 1NCT03517046
Study to Assess the Safety of Treatment of Articular Cartilage Lesions With CartiLife®
A Phase 1 study testing CartiLife in people with Articular Cartilage Lesion of Knee, run by Biosolution Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Articular Cartilage Lesion of Knee
- What is being tested?
- CartiLife
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 17 Jul 2012to 10 Dec 2013
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
- Patients with arthritis associated with autoimmune disease
- Patients hypersensitive to bovine protein
- Patients with Haemophilia or markedly reduced immune function
- Patients hypersensitive to antibiotics such as gentamicin
- Patients with arterial bleeding and severe venous bleeding
Show all 11Show fewer
- 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, 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
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.
- Conditions
- Articular Cartilage Lesion of Knee
- Being tested
- CartiLife
- Keywords
- Arthritis, Articular Cartilage, Autologous Chondrocyte Implantation, Degenerative Arthritis, Cartilage Lesion, Cartilage Defect
- Medical subject headings
- Arthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CartiLifeDrug
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 with a fibrin adhesive through minimal arthrotomy.
| Study group | Role | What they receive |
|---|---|---|
| CartiLife (low-dose group) | Experimental | Total defect volume in low-dose group is less than 2 ㎤. Low- and high-dose group are sequentially processed. Receives: Drug: CartiLife |
| CartiLife (high-dose group) | Experimental | Total defect volume in High-dose group is 2 ~ 4 ㎤. Receives: Drug: CartiLife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Number of adverse events
Measured: 48 weeks
Secondary outcomes (2)
IKDC (International Knee Documentation Committee)
Changes in IKDC scores during each visit
The IKDC Score is a subjective questionnaire filled out by the patient ranges from 0-100, where a score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms
Measured: Baseline to 48 weeks
X-ray
Changes in structure during each visit
Measured: Baseline 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start17 Jul 2012
- Primary completion10 Dec 2013
- Study completion10 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Articular Cartilage Lesion of 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosolution Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyung Hee University Hospital
- Responsible party
- Sponsor
- Investigators
- Kyoung Ho Yoon, MD, PhD, Principal investigator, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517046
- Sponsor's protocol ID
- MCTT-CTL-I
- Status last verified
- Mar 2018
- First submitted
- 8 Mar 2018
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yoon KH, Park JY, Lee JY, Lee E, Lee J, Kim SG. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation for Treatment of Articular Cartilage Defect. Am J Sports Med. 2020 Apr;48(5):1236-1245. doi: 10.1177/0363546520905565. Epub 2020 Mar 3.
PubMed 32125878
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03517046
- Acronym / sponsor ID
- MCTT-CTL-I
- Conditions
- Articular Cartilage Lesion of Knee
- Keywords
- Arthritis, Articular Cartilage, Autologous Chondrocyte Implantation, Degenerative Arthritis, Cartilage Lesion, Cartilage Defect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Biosolution Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kyung Hee University Hospital
- Study start
- 17 Jul 2012 (actual)
- Primary completion
- 10 Dec 2013 (actual)
- Study completion
- 10 Dec 2013 (actual)
- First posted
- 7 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CartiLife (low-dose group) | Experimental | Drug: CartiLifeTotal defect volume in low-dose group is less than 2 ㎤. Low- and high-dose group are sequentially processed. |
| CartiLife (high-dose group) | Experimental | Drug: CartiLifeTotal defect volume in High-dose group is 2 ~ 4 ㎤. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Patients that are able to walk without aid
Key exclusion criteria (11 listed)
- Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis
- Patients with arthritis associated with autoimmune disease
- Patients hypersensitive to bovine protein
- Patients with Haemophilia or markedly reduced immune function
- Patients hypersensitive to antibiotics such as gentamicin
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 |
|---|---|---|
| CartiLifeBiological: 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 with a fibrin adhesive through minimal arthrotomy. | Drug | CartiLife (high-dose group), CartiLife (low-dose group) |
Primary outcome
Adverse events
Time frame: 48 weeks
Number of adverse events
2 secondary outcomes
IKDC (International Knee Documentation Committee)
Time frame: Baseline to 48 weeks
X-ray
Time frame: Baseline 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 7 May 2018.
- Derived from this study: PubMed 32125878Yoon KH, Park JY, Lee JY, Lee E, Lee J, Kim SG. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation for Treatment of Articular Cartilage Defect. Am J Sports Med. 2020 Apr;48(5):1236-1245. doi: 10.1177/0363546520905565. Epub 2020 Mar 3.
- Individual participant dataSharing planned: Undecided
Related trials for Articular Cartilage Lesion of Knee
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
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
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 Yoon, MD, PhD principal investigator
Kyunghee University Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CartiLife in people with Articular Cartilage Lesion of 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 11 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 7 May 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse events (time frame: 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 NCT03517046, which also lists 1 linked publication.
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 7 May 2018.