Osteochondral Lesion of TalusEarly Phase 1CartistemNCT02338375
Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product
A Early Phase 1 study testing Cartistem in people with Osteochondral Lesion of Talus, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) on currently standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Osteochondral Lesion of Talus
- What is being tested?
- Cartistem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Dec 2015
- Phase
- Early 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-responder to conservative treatment for radiographically confirmed (by MRI) osteochondral lesion of talus with ankle pain and/or stiffness and less than 75 of the AOFAS score
- Age between 20 and 70 year-old
- Appropriate function of blood clot PT(INR) < 1.5, APTT <1.5×control
- Appropriate renal function Creatinine ≤ 2.0 ㎎/㎗, proteinuria less than trace with Dipstick urine test
- Appropriate hepatic function Bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
- No evidence of autoimmue disorder As screening test anti-nuclear antibody and/or anti-thyroglobulin antibody, if positive rheumatologist referral needed to confirm diagnosis
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- No surgery or radiotherapy for the same ankle joint within 6 weeks
- Female patients agreeing with maintenance of contraception during study period
- No ligament instability greater than grade II (Grade 0 : none, Grade Ⅰ: 0~5㎜, GradeⅡ: 5~10㎜, Grade Ⅲ: >10㎜) with physical exam
- Patients agreeing with participation in this study and signed on informed consent by their own will
Who cannot join
- Degenerative ankle arthritis patients
- Patients with autoimmune disease
- Patients with infectious disease needed parenteral antibiotics
- Patients with myocardial infarction, congestive heart failure, other serious heart diseases or uncontrollable hypertion
- Patients with other serious medical illness
- Pregnancy or breast feeding patients
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- Past history related with psychiatric illness or epilepsy
- Alcoholic abuse
- Heavy smoker
- Chronic inflammatory disease including rheumatoid arthritis
- Participants of other clinical trial within 4 weeks
- Patients treated with immunosuppressing agents such as Cyclosporin A or azathioprine within 6 weeks
- Unstable ankle joint(lesion site) greater than grade II at physical exam (Grade 0 : none, grade Ⅰ: 0~5㎜, GradeⅡ: 5~10㎜, Grade Ⅲ: >10㎜)
- Other inappropriate patients determined by the prinicipal investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of the Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product With Microfracture for Osteochondral Lesion of Talus Patients
The purpose of this study is to evaluate the safety and efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) on currently standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus.
Read the detailed description
same as above
- Conditions
- Osteochondral Lesion of Talus
- Being tested
- Cartistem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CartistemBiological
Cartistem is allogenic umbilical cord blood-derived stem cell product. Cartistem is 500uL/cm2 applied according to the lesion.
| Study group | Role | What they receive |
|---|---|---|
| Cartistem | Experimental | For control group patients currently standard treatment of arthroscopic curettage and microfracture is performed, and for study group patients allogenic umbilical cord blood-derived mesenchymal stem cell product(Cartistem®) is added on the lesion after above mentioned procedure. Receives: Biological: Cartistem |
| standard treatment | Active comparator | standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus Receives: Biological: Cartistem |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by American Orthopaedic Foot and Ankle Society(AOFAS) HINDFOOT/ANKLE SCALE
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 48
Secondary outcomes (1)
evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by 100-mm VAS(Visual Analogue Scale)
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startDec 2012
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral Lesion of TalusStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChulWon Ha, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338375
- Sponsor's protocol ID
- 2012-10-078
- Acronym
- Cartistem
- Status last verified
- Jan 2015
- First submitted
- 31 Jul 2013
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of the Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product With Microfracture for Osteochondral Lesion of Talus Patients
- ClinicalTrials.gov ID
- NCT02338375
- Acronym / sponsor ID
- Cartistem / 2012-10-078
- Conditions
- Osteochondral Lesion of Talus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 Jan 2015 (estimated)
- 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 safety and efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) on currently standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus.
Detailed description
same as above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cartistem | Experimental | Biological: CartistemFor control group patients currently standard treatment of arthroscopic curettage and microfracture is performed, and for study group patients allogenic umbilical cord blood-derived mesenchymal stem cell product(Cartistem®) is added on the lesion after above mentioned procedure. |
| standard treatment | Active comparator | Biological: Cartistemstandard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Non-responder to conservative treatment for radiographically confirmed (by MRI) osteochondral lesion of talus with ankle pain and/or stiffness and less than 75 of the AOFAS score
- Age between 20 and 70 year-old
- Appropriate function of blood clot PT(INR) < 1.5, APTT <1.5×control
- Appropriate renal function Creatinine ≤ 2.0 ㎎/㎗, proteinuria less than trace with Dipstick urine test
- Appropriate hepatic function Bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
Key exclusion criteria (14 listed)
- Degenerative ankle arthritis patients
- Patients with autoimmune disease
- Patients with infectious disease needed parenteral antibiotics
- Patients with myocardial infarction, congestive heart failure, other serious heart diseases or uncontrollable hypertion
- Patients with other serious medical illness
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 |
|---|---|---|
| CartistemCartistem is allogenic umbilical cord blood-derived stem cell product. Cartistem is 500uL/cm2 applied according to the lesion. | Biological | Cartistem, standard treatment |
Primary outcome
evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by American Orthopaedic Foot and Ankle Society(AOFAS) HINDFOOT/ANKLE SCALE
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 48
1 secondary outcome
evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by 100-mm VAS(Visual Analogue Scale)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cartistem in people with Osteochondral Lesion of Talus, run by Samsung Medical Center at 1 site 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 10 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by American Orthopaedic Foot and Ankle Society(AOFAS) HINDFOOT/ANKLE SCALE (time frame: Baseline, Week 4, Week 8, Week 12, Week 24, 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 14 Jan 2015.