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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.

Tracking Information
First Submitted Date  ICMJE June 19, 2012
First Posted Date  ICMJE June 25, 2012
Last Update Posted Date April 20, 2017
Study Start Date  ICMJE June 2012
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01626677 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect
Official Title  ICMJE Long Term Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Osteoarthritis
  • Defect of Articular Cartilage
Intervention  ICMJE
  • Biological: CARTISTEM
    A single dose of 500㎕/㎠ of cartilage defect
    Other Name: hUCB-MSCs
  • Procedure: Microfracture
    Active control
    Other Name: Conventional surgical treatment
Study Arms  ICMJE
  • Experimental: CARTISTEM
    A single dose of 500㎕/㎠ of cartilage defect
    Intervention: Biological: CARTISTEM
  • Active Comparator: Microfracture
    conventional treatment method
    Intervention: Procedure: Microfracture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2012)
103
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01626677
Other Study ID Numbers  ICMJE CARTISTEM_CR_F/U
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Medipost Co Ltd.
Study Sponsor  ICMJE Medipost Co Ltd.
Collaborators  ICMJE Dong-A Pharmaceutical Co., Ltd.
Investigators  ICMJE
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
PRS Account Medipost Co Ltd.
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP