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

Sponsor

Medipost Co Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01626677

Collaborator

Dong-A Pharmaceutical Co., Ltd. (Industry)

103

Enrollment

Locations

Arms

Duration (Months)

10.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Osteoarthritis Defect of Articular Cartilage	Biological: CARTISTEM Procedure: Microfracture	Phase 3

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 Design

Study Type:

Interventional

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 :

Jun 1, 2012

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CARTISTEM A single dose of 500㎕/㎠ of cartilage defect	Biological: CARTISTEM A single dose of 500㎕/㎠ of cartilage defect Other Names: hUCB-MSCs
Active Comparator: Microfracture conventional treatment method	Procedure: Microfracture Active control Other Names: Conventional surgical treatment

Arm

Intervention/Treatment

Experimental: CARTISTEM

A single dose of 500㎕/㎠ of cartilage defect

Biological: CARTISTEM

A single dose of 500㎕/㎠ of cartilage defect

Other Names:

hUCB-MSCs

Active Comparator: Microfracture

conventional treatment method

Procedure: Microfracture

Active control

Other Names:

Conventional surgical treatment

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Inha University Hospital	Incheon	Korea, Republic of	400-711
2	Gachon University Gil Hospital	Incheon	Korea, Republic of	405-760
3	Kangbuk Samsung Hospital	Seoul	Korea, Republic of	110-746
4	Hanyang University Medical Center	Seoul	Korea, Republic of	133-792
5	Seoul Veterans Hospital	Seoul	Korea, Republic of	134-060
6	Samsung Medical Center	Seoul	Korea, Republic of	135-710
7	Gangnam Severance Hospital	Seoul	Korea, Republic of	135-720
8	Asan Medical Center	Seoul	Korea, Republic of	138-736
9	Korea University Guro Hospital	Seoul	Korea, Republic of	152-703
10	Ewha Womans University Mokdong Hospital	Seoul	Korea, Republic of	158-710

Sponsors and Collaborators

Medipost Co Ltd.
Dong-A Pharmaceutical Co., Ltd.

Investigators

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