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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
A single dose of 500㎕/㎠ of cartilage defect
Active control
Inha University Hospital
Incheon, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Hanyang University Medical Center
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)
Time frame: 36 months, 48 months, and 60 months
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)
Time frame: 36 months, 48 months, and 60 months
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Seoul, South Korea
Seoul Veterans Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea