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

Phase 3

Completed

• Conditions: Defect of Articular Cartilage; Degenerative Osteoarthritis
• Interventions: Procedure: Microfracture; Biological: CARTISTEM

• Registration Number: NCT01626677
• Lead Sponsor: Medipost Co Ltd.

Brief 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. Subjects who participated in and completed the Phase III trial (NCT01041001) will be tracked until the 60 month post-treatment timepoint.

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-25
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microfracture	Microfracture	conventional treatment method
CARTISTEM	CARTISTEM	A single dose of 500㎕/㎠ of cartilage defect

Primary Outcome Measures

Name	Time	Method
Degree of improvement in knee assessments compared to the active control (microfracture)	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)

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	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)

Trial Locations

Locations (10)

Hanyang University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of

Gachon University Gil Hospital; 🇰🇷 Incheon, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul Veterans Hospital; 🇰🇷 Seoul, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of