Chondral or Osteochondral Lesion of TalusPhase 3NCT04310215
Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus
A Phase 3 study testing CARTISTEM® and Microfracture in people with Chondral or Osteochondral Lesion of Talus, run by Hyundai Bioland Co., Ltd. at 6 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of adding CARTISTEM®(allogenic umbilical cord blood-derived stem cell product) on microfracture, a currently standard treatment for OLT, in patients with talar chondral or osteochondral defect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chondral or Osteochondral Lesion of Talus
- What is being tested?
- CARTISTEM® and Microfracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 3 Mar 2020to 13 Jun 2022
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Talar chondral/osteochondral lesion confirmed by radiographical exam at screening or diagnosis, an AOFAS score of 75 or below
- Ankle joint pain/stiffness with no response to conservative treatment for more than 12 weeks
- Ankle joint cartilage injury of defect of ICRS grade Ⅳ in MRI
- Male or female aged more than 18
- A one-sided lesion
- Appropriate function of blood clot: PT(INR) < 1.5×ULN, aPTT <1.5×ULN
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- Appropriate renal function: Creatinine ≤ 2.0 ㎎/㎗, Proteinuria ≤ trace
- Appropriate hepatic function: Total bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
- No evidence of auto-immune disorder: According to investigator's judgement based on relevent symtom and physical exam, anti-nuclear antibody and anti-thyroglobulin antibody tests are able to performed and confirmed negative (If positive, there are possible cases according to diagnostic opinion of medical department)
- No surgery or radiotherapy for the same ankle joint within 6 weeks
- Female patients agreeing with maintenance of contraception* during study period
- hormone contraceptive, implants of intrauterine device or intrauterine system, double barrier contraception[Concurrent use of diaphragm or cervical occlusive cap and male condom], surgical sterilisation, etc.
- No chronic ligament instability more than grade Ⅲ (Grade 0: none, Grade Ⅰ: 1~5㎜, GradeⅡ: 5~10㎜, Grade Ⅲ: >10㎜)
- Patients agreeing with participation in this study and signed on informed consent by their own will
Who cannot join
- Degenerative arthritis in ankle(Kellgren Lawrence Grade 3-4)
- Autoimmune disease
- Infectious disease need to administration of parenteral antibiotics
- Myocardial infarction, congestive heart failure, other serious cardiac disorder or uncontrolled resistant hypertension
- Serious medical disease(Ex. Kidney disease such as chronic renal failure or Glomerulonephritis, etc., acute/chronic liver disease such as liver cirrhosis, fatty liver etc., medical history of malignancy*)
- Complete remission status is possible.
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- Pregnancy or breast-feeding
- Psychiatric history or epilepsy
- Alcohol abuse
- Heavy smoker
- Chronic inflammatory disease such as rheumatoid arthritis
- Participants other clinical trials within 4 weeks
- Administration of immunosuppressing agents such as Cyclosporin A or azathioprine within 6 weeks
- Patients with acute ligament injury and clinically significant chronic ligament instability
- Patients treated with surgery or cell therapy product for the same disease
- Patients with hypersensitivity or allergy history to bovine protein, hyaluronic acid and gentamicin
- Other inappropriate patients determined by the principal investigator
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Chungnam National University Hospital
Daejeon, Jung-gu, 35015
Inha University Hospital
Incheon, Jung-gu, 22332
Kyunghee University Medical Center
Seoul, Dongdaemun-gu, 02447
Gangnam Severance Hospital
Seoul, Gangnam-gu, 06273
Samsung Medical Center
Seoul, Gangnam-gu, 06351
Korea University Guro Hospital
Seoul, Guro-gu, 08308
About this study
Official title: A Multi-center, Single-blind, Randomized, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Adding CARTISTEM® on Microfracture in Patients With Talar Chondral or Osteochondral Defect
The purpose of this study is to evaluate the efficacy and safety of adding CARTISTEM®(allogenic umbilical cord blood-derived stem cell product) on microfracture, a currently standard treatment for OLT, in patients with talar chondral or osteochondral defect.
- Being tested
- CARTISTEM®, Microfracture
- Keywords
- OLT, Talus, Chondral Lesion, Osteochondral Lesion, Human umbilical cord blood-derived stem cell, MSC, Mesenchymal stem cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARTISTEM®Biological
*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠
- Procedure: Microfracture
- Biological: CARTISTEM®(Human Umbilical Cord Blood-derived Mesenchymal Stem Cell product)
MicrofractureProcedure or surgery
*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠
- Procedure: Microfracture
| Study group | Role | What they receive |
|---|---|---|
| Microfracture + CARTISTEM® | Experimental | CARTISTEM® is added on the lesion as a single dose of 500 ㎕/㎠ according to the defect size after arthroscopic curettage and microfracture. Receives: Biological: CARTISTEM® |
| Microfracture | Active comparator | Standard treatment of arthroscopic curettage and microfracture is performed for cartilage defect. Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICRS-Cartilage Repair Assessment Total Score
Arthroscopic evaluation of articular cartilage repair
: The score range from 12(normal) to 1(severely abnormal) where lower scores indicate more severity of injury
Measured: Week 48
Secondary outcomes (7)
ICRS-Cartilage Repair Assessment Overall Grade
The grades range from 1(normal) to 4 (severely abnormal) where lower grades indicate more complete repair
Measured: Week 48
Improvement degree of Cartilage Repair by MRI
Changes in MOCART(Magnetic resonance Observation of Cartilage Repair Tissue) score
: MOCART score is a 9-part and 29-item scoring system, also resulting in a find cartilage repair tissue score between 0 and 100 points. 100 points represent the best imaginable score
Measured: Week 0 and 48
Degree of Functional improvement in FAOS(Foot & Ankle Outcome Score)
: FAOS consists in 42 items that cover 5 dimensions (symptoms, pain, activities of daily living, sport and recreation activities, and quality of life. Raw scores of each sub-scales results of the sum of each items. A normalized score (100 indicationg no symptoms and 0 indicating extreame sysmptoms) is calculated for each subscale
Measured: Week 0, 24 and 48
Degree of Functional improvement in AOFAS(The American Orthopaedic Foot & Ankle Score)
: AOFAS consists in 9 items that can be divided into 3 sub-scales (pain, function and alignment). 100 points of 1 to 100 represent no symptoms or impairments
Measured: Week 0, 24 and 48
Degree of Functional improvement in Tegner activity score
: Tegner activity represents the highest level of activity on scale of 0 to 10 that you are able to participate in currently . The higher values represent a better outcome
Measured: Week 0, 24 and 48
Degree of Quality of Life improvement in SF-36(Short Form Health Survey-36)
: SF-36 comprises 36 items divided into two components of physical health and mental health. Higher scores between 0 and 100 represent better health status
Measured: Week 0, 24 and 48
Degree of pain improvement in 100 mm VAS(Visual Analogue Scale)
- VAS represents higher scores mean higher pain
- 0 mm (no pain) and 100 mm (worst pain)
Measured: Week 0, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start3 Mar 2020
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chondral or Osteochondral Lesion of TalusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, Single-blinded, Stratified randomized
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyundai Bioland Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medipost Co Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310215
- Sponsor's protocol ID
- CARTISTEM_2019_01
- Status last verified
- Aug 2022
- First submitted
- 12 Mar 2020
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single-blind, Randomized, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Adding CARTISTEM® on Microfracture in Patients With Talar Chondral or Osteochondral Defect
- ClinicalTrials.gov ID
- NCT04310215
- Acronym / sponsor ID
- CARTISTEM_2019_01
- Keywords
- OLT, Talus, Chondral Lesion, Osteochondral Lesion, Human umbilical cord blood-derived stem cell, MSC, Mesenchymal stem cell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hyundai Bioland Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Medipost Co Ltd.
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 17 Mar 2020 (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 evaluate the efficacy and safety of adding CARTISTEM®(allogenic umbilical cord blood-derived stem cell product) on microfracture, a currently standard treatment for OLT, in patients with talar chondral or osteochondral defect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A multicenter, Single-blinded, Stratified randomized
| Arm | Type | Receives |
|---|---|---|
| Microfracture + CARTISTEM® | Experimental | Biological: CARTISTEM®CARTISTEM® is added on the lesion as a single dose of 500 ㎕/㎠ according to the defect size after arthroscopic curettage and microfracture. |
| Microfracture | Active comparator | Procedure: MicrofractureStandard treatment of arthroscopic curettage and microfracture is performed for cartilage defect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Talar chondral/osteochondral lesion confirmed by radiographical exam at screening or diagnosis, an AOFAS score of 75 or below
- Ankle joint pain/stiffness with no response to conservative treatment for more than 12 weeks
- Ankle joint cartilage injury of defect of ICRS grade Ⅳ in MRI
- Male or female aged more than 18
- A one-sided lesion
Key exclusion criteria (17 listed)
- Degenerative arthritis in ankle(Kellgren Lawrence Grade 3-4)
- Autoimmune disease
- Infectious disease need to administration of parenteral antibiotics
- Myocardial infarction, congestive heart failure, other serious cardiac disorder or uncontrolled resistant hypertension
- Serious medical disease(Ex. Kidney disease such as chronic renal failure or Glomerulonephritis, etc., acute/chronic liver disease such as liver cirrhosis, fatty liver etc., medical history of malignancy*)
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 |
|---|---|---|
| CARTISTEM®*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠ 1. Procedure: Microfracture 2. Biological: CARTISTEM®(Human Umbilical Cord Blood-derived Mesenchymal Stem Cell product) | Biological | Microfracture + CARTISTEM® |
| Microfracture*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠ 1. Procedure: Microfracture | Procedure or surgery | Microfracture |
Primary outcome
ICRS-Cartilage Repair Assessment Total Score
Time frame: Week 48
Arthroscopic evaluation of articular cartilage repair : The score range from 12(normal) to 1(severely abnormal) where lower scores indicate more severity of injury
7 secondary outcomes
ICRS-Cartilage Repair Assessment Overall Grade
Time frame: Week 48
Improvement degree of Cartilage Repair by MRI
Time frame: Week 0 and 48
Degree of Functional improvement in FAOS(Foot & Ankle Outcome Score)
Time frame: Week 0, 24 and 48
Degree of Functional improvement in AOFAS(The American Orthopaedic Foot & Ankle Score)
Time frame: Week 0, 24 and 48
Degree of Functional improvement in Tegner activity score
Time frame: Week 0, 24 and 48
Degree of Quality of Life improvement in SF-36(Short Form Health Survey-36)
Time frame: Week 0, 24 and 48
Degree of pain improvement in 100 mm VAS(Visual Analogue Scale)
Time frame: Week 0, 24 and 48
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 29 Nov 2022.
- Individual participant dataSharing planned: No. IPD will not be shared to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CARTISTEM® and Microfracture in people with Chondral or Osteochondral Lesion of Talus, run by Hyundai Bioland Co., Ltd. at 6 sites in South Korea.
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 14 inclusion and 17 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 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
ICRS-Cartilage Repair Assessment Total Score (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2022.