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

Primary Purpose

Degenerative Osteoarthritis, Defect of Articular Cartilage

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CARTISTEM

Microfracture

About this trial

This is an interventional treatment trial for Degenerative Osteoarthritis focused on measuring Umbilical Cord Blood, Mesenchymal Stem Cells, Cartilage injury, Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CARTISTEM

Microfracture

Arm Description

A single dose of 500㎕/㎠ of cartilage defect

conventional treatment method

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT01626677

First Posted

June 19, 2012

Last Updated

April 19, 2017

Sponsor

Medipost Co Ltd.

Collaborators

Dong-A Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01626677

Brief Title

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

Official Title

Long Term Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medipost Co Ltd.

Collaborators

Dong-A Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Osteoarthritis, Defect of Articular Cartilage

Keywords

Umbilical Cord Blood, Mesenchymal Stem Cells, Cartilage injury, Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CARTISTEM

Arm Type

Experimental

Arm Description

A single dose of 500㎕/㎠ of cartilage defect

Arm Title

Microfracture

Arm Type

Active Comparator

Arm Description

conventional treatment method

Intervention Type

Biological

Intervention Name(s)

CARTISTEM

Other Intervention Name(s)

hUCB-MSCs

Intervention Description

A single dose of 500㎕/㎠ of cartilage defect

Intervention Type

Procedure

Intervention Name(s)

Microfracture

Other Intervention Name(s)

Conventional surgical treatment

Intervention Description

Active control

Primary Outcome Measure Information:

Title

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

Description

Time Frame

36 months, 48 months, and 60 months

Secondary Outcome Measure Information:

Title

Number of subjects with adverse events

Description

Time Frame

36 months, 48 months, and 60 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: