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Degenerative OsteoarthritisPhase 3NCT01626677

Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect

A Phase 3 study testing CARTISTEM and Microfracture in people with Degenerative Osteoarthritis and Defect of Articular Cartilage, run by Medipost Co Ltd. at 10 sites in South Korea.

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

This is a long term follow-up study to investigate the safety and efficacy of CARTISTEM®, human umbilical cord blood-derived mesenchymal stem cells, in repair of cartilage injury or defects, compared with microfracture. Read more about this study

Who is it for?
Ages 18 years and older
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
103 participants
Where
10 sitesSouth Korea
Study dates
Jun 2012to May 2015
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

  • Patients with knee joint cartilage defect or injury of ICRS (International Cartilage Repair Society) Grade 4 confirmed by arthroscopy (At screening, patients diagnosed as such with an MRI may be included)
  • Male or female patients at least 18 years of age
  • Patients whose lesion (unilateral joint) is 2 ㎠ ~ 9㎠ in size
  • Patients with articular swelling, tenderness and active range of motion of Grade 2 or below
  • Patients with pain in affected joint of 60-mm or below on a 100-mm VAS (visual analogue scale)
  • Patients with adequate blood coagulation activity: PT(INR) < 1.5, APTT <1.5×control
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  • Patients with adequate renal function: Creatinine ≤ 2.0 ㎎/㎗, levels of proteinuria measured with Dipstick: trace or less
  • Patients with adequate hepatic function: Bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
  • Patients who have received no surgery or radiation therapy in the affected joint within the past 6 six weeks, and have recovered from the side effects of such past treatments
  • Female patients of childbearing potential must agree to practice adequate methods of birth control to prevent pregnancy during the study
  • Patients whose physical examination results show no ligament instability of Grade II or above (Grade 0: none, Grade I: 0-5 mm, Grade II: 5-10 mm, Grade III: >10 mm)
  • Patients who voluntarily agreed to enroll in the study and signed an informed consent form

Who cannot join

  • Patients with autoimmune disease or the medical history
  • Patients with infections requiring parenteral administration of antibiotics
  • Patients with myocardial infarction, ischemic heart failure, other serious heart conditions or uncontrolled hypertension, or any medical history of such diseases
  • Patients with serious internal diseases
  • Patients who are currently pregnant or nursing
  • Patients with psychotic diseases, epilepsy, or any history of such diseases
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  • Patients with alcohol abuse
  • Patients who smoke excessively
  • Patients with chronic inflammatory articular diseases such as rheumatoid arthritis
  • Patients who were enrolled in any other clinical trials within the past four weeks
  • Patients who had been administered with immunosuppressants such as Cyclosporin A or azathioprine within the past six weeks
  • Patients whose physical examination results show ligament instability of Grade II or above (Grade 0: none, Grade I: 0-5 mm, Grade II: 5-10 mm, Grade III: >10 mm)
  • Patients with a known history of hypersensitivity/allergy to gentamicin
  • Patients whom the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

South Korea10 sites

  • Inha University Hospital

    Incheon, 400-711

  • Gachon University Gil Hospital

    Incheon, 405-760

  • Kangbuk Samsung Hospital

    Seoul, 110-746

  • Hanyang University Medical Center

    Seoul, 133-792

  • Seoul Veterans Hospital

    Seoul, 134-060

  • Samsung Medical Center

    Seoul, 135-710

  • Gangnam Severance Hospital

    Seoul, 135-720

  • Asan Medical Center

    Seoul, 138-736

  • Korea University Guro Hospital

    Seoul, 152-703

  • Ewha Womans University Mokdong Hospital

    Seoul, 158-710

Other trials in South Korea

About this study

Official title: Long Term Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee

This is a long term follow-up study to investigate the safety and efficacy of CARTISTEM®, human umbilical cord blood-derived mesenchymal stem cells, in repair of cartilage injury or defects, compared with microfracture. Subjects who participated in and completed the Phase III trial (NCT01041001) will be tracked until the 60 month post-treatment timepoint.

Read the detailed description

This long term follow-up study is performed to assess the long-term safety and efficacy of CARTISTEM®, human umbilical cord blood-derived mesenchymal stem cells, in repair of cartilage injury or defects, compared with microfracture. Subjects, who were either administered CARTISTEM or treated with conventional microfracture in the primary phase III study (NCT01041001), will be further observed using various subjective knee assessments and MRI T2 mapping until the 60 month post-treatment timepoint.

Being tested
CARTISTEM, Microfracture
Keywords
Umbilical Cord Blood, Mesenchymal Stem Cells, Cartilage injury, Osteoarthritis
Medical subject headings
Joint Diseases, Osteoarthritis

What participants receive

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

  • CARTISTEMBiological

    Also called hUCB-MSCs

    A single dose of 500㎕/㎠ of cartilage defect

  • MicrofractureProcedure or surgery

    Also called Conventional surgical treatment

    Active control

Study groups in NCT01626677
Study groupRoleWhat they receive
CARTISTEMExperimentalA single dose of 500㎕/㎠ of cartilage defect
Receives: Biological: CARTISTEM
MicrofractureActive comparatorconventional treatment method
Receives: Procedure: Microfracture

What is being measured

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

  1. Degree of improvement in knee assessments compared to the active control (microfracture)

    Knee assessments will be performed using the following tools:

    • IKDC (International Knee Documentation Committee)
    • Pain score on VAS (Visual Analogue Scale)
    • WOMAC (Western Ontario and McMaster Universities Arthritis Index)

    Measured: 36 months, 48 months, and 60 months

Secondary outcomes (1)

  1. Number of subjects with adverse events

    Systemic and local adverse events especially attributable to the implanted cells will be assessed.

    • General physical examinations: vital signs, blood tests
    • Physical assessments of the knee: swelling, tenderness, pain, range of motion
    • Tumor formation at the implantation site: radiological evaluation using MRI(T1(dGEMRIC)and T2 mapping)

    Measured: 36 months, 48 months, and 60 months

Timeline

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

  1. First posted25 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

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
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01626677
Sponsor's protocol ID
CARTISTEM_CR_F/U
Status last verified
Apr 2017
First submitted
19 Jun 2012
Last updated
20 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lim HC, Park YB, Ha CW, Cole BJ, Lee BK, Jeong HJ, Kim MK, Bin SI, Choi CH, Choi CH, Yoo JD; Cartistem Research Group; Yoon JR, Chung JY. Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cell Implantation Versus Microfracture for Large, Full-Thickness Cartilage Defects in Older Patients: A Multicenter Randomized Clinical Trial and Extended 5-Year Clinical Follow-up. Orthop J Sports Med. 2021 Jan 12;9(1):2325967120973052. doi: 10.1177/2325967120973052. eCollection 2021 Jan.

    PubMed 33490296

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CARTISTEM and Microfracture in people with Degenerative Osteoarthritis and Defect of Articular Cartilage, run by Medipost Co Ltd. at 10 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 12 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: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

Degree of improvement in knee assessments compared to the active control (microfracture) (time frame: 36 months, 48 months, and 60 months). 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 NCT01626677, 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 20 Apr 2017.

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