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

Medipost

Status and phase

Completed

Phase 3

Conditions

Degenerative Osteoarthritis

Defect of Articular Cartilage

Treatments

Biological: CARTISTEM

Procedure: Microfracture

Study type

Interventional

Funder types

Industry

Identifiers

NCT01626677

CARTISTEM_CR_F/U

Details and patient eligibility

About

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.

Full 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.

Enrollment

103 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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