Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01626677 |
Recruitment Status :
Completed
First Posted : June 25, 2012
Last Update Posted : April 20, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Degenerative Osteoarthritis Defect of Articular Cartilage | Biological: CARTISTEM Procedure: Microfracture | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 103 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Long Term Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | May 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: CARTISTEM
A single dose of 500㎕/㎠ of cartilage defect
|
Biological: CARTISTEM
A single dose of 500㎕/㎠ of cartilage defect
Other Name: hUCB-MSCs |
Active Comparator: Microfracture
conventional treatment method
|
Procedure: Microfracture
Active control
Other Name: Conventional surgical treatment |
- Degree of improvement in knee assessments compared to the active control (microfracture) [ Time Frame: 36 months, 48 months, and 60 months ]
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)
- Number of subjects with adverse events [ Time Frame: 36 months, 48 months, and 60 months ]
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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626677
Korea, Republic of | |
Inha University Hospital | |
Incheon, Korea, Republic of, 400-711 | |
Gachon University Gil Hospital | |
Incheon, Korea, Republic of, 405-760 | |
Kangbuk Samsung Hospital | |
Seoul, Korea, Republic of, 110-746 | |
Hanyang University Medical Center | |
Seoul, Korea, Republic of, 133-792 | |
Seoul Veterans Hospital | |
Seoul, Korea, Republic of, 134-060 | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 135-710 | |
Gangnam Severance Hospital | |
Seoul, Korea, Republic of, 135-720 | |
Asan Medical Center | |
Seoul, Korea, Republic of, 138-736 | |
Korea University Guro Hospital | |
Seoul, Korea, Republic of, 152-703 | |
Ewha Womans University Mokdong Hospital | |
Seoul, Korea, Republic of, 158-710 |
Principal Investigator: | Hong-chul Lim, MD, PhD | Korea University Guro Hospital | |
Principal Investigator: | Beom-gu Lee, MD, PhD | Gachon University Gil Medical Center | |
Principal Investigator: | Jong-hyeok Choi, MD, PhD | Gangnam Severance Hospital | |
Principal Investigator: | Hwa-jae Jeong, MD, PhD | Kangbuk Samsung Hospital | |
Principal Investigator: | Chul-won Ha, MD, PhD | Samsung Medical Center | |
Principal Investigator: | Jung-ro Yoon, MD, PhD | Seoul Veterans Hospital | |
Principal Investigator: | Seong-il Bin, MD, PhD | Asan Medical Center | |
Principal Investigator: | Jae-doo Yoo, MD, PhD | Ewha Womans Mokdong Hospital | |
Principal Investigator: | Myung-ku Kim, MD, PhD | Inha University Hospital | |
Principal Investigator: | Choong-hyuk Choi, MD, PhD | Hanyang University | |
Principal Investigator: | Young-Chul Yoon, MD, PhD | Samsung Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Medipost Co Ltd. |
ClinicalTrials.gov Identifier: | NCT01626677 |
Obsolete Identifiers: | NCT01923532 |
Other Study ID Numbers: |
CARTISTEM_CR_F/U |
First Posted: | June 25, 2012 Key Record Dates |
Last Update Posted: | April 20, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Umbilical Cord Blood Mesenchymal Stem Cells Cartilage injury Osteoarthritis |
Osteoarthritis Fractures, Stress Arthritis Joint Diseases |
Musculoskeletal Diseases Rheumatic Diseases Fractures, Bone Wounds and Injuries |