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

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ClinicalTrials.gov Identifier: NCT01626677
Recruitment Status : Completed
First Posted : June 25, 2012
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Medipost Co Ltd.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : June 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626677


Locations
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Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of, 400-711
Gachon University Gil Hospital
Incheon, Korea, Republic of, 405-760
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 110-746
Hanyang University Medical Center
Seoul, Korea, Republic of, 133-792
Seoul Veterans Hospital
Seoul, Korea, Republic of, 134-060
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of, 158-710
Sponsors and Collaborators
Medipost Co Ltd.
Dong-A Pharmaceutical Co., Ltd.
Investigators
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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
More Information
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Additional Information:
Study to Compare the Efficacy and Safety of Cartistem&#174; and Microfracture in Patients With Knee Articular Cartilage Injury or Defect  This link exits the ClinicalTrials.gov site

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Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT01626677     History of Changes
Obsolete Identifiers: NCT01923532
Other Study ID Numbers: CARTISTEM_CR_F/U
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medipost Co Ltd.:
Umbilical Cord Blood
Mesenchymal Stem Cells
Cartilage injury
Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Fractures, Stress
Arthritis
Joint Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Fractures, Bone
Wounds and Injuries