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

April 19, 2017 updated by: Medipost Co Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of, 400-711
        • Inha University Hospital
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 135-720
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 110-746
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 158-710
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 133-792
        • Hanyang University Medical Center
      • Seoul, Korea, Republic of, 134-060
        • Seoul Veterans Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of improvement in knee assessments compared to the active control (microfracture)
Time Frame: 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)
36 months, 48 months, and 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with adverse events
Time Frame: 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)
36 months, 48 months, and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipost Co Ltd.

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

June 19, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 25, 2012

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARTISTEM_CR_F/U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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