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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Medipost Co Ltd.
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Medipost Co Ltd.
ClinicalTrials.gov Identifier:
NCT01626677
First received: June 19, 2012
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Degenerative Osteoarthritis
Defect of Articular Cartilage
Biological: CARTISTEM
Procedure: Microfracture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long Term Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee

Resource links provided by NLM:


Further study details as provided by Medipost Co Ltd.:

Primary Outcome Measures:
  • Degree of improvement in knee assessments compared to the active control (microfracture) [ Time Frame: 36 months, 48 months, and 60 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 36 months, 48 months, and 60 months ] [ Designated as safety issue: Yes ]

    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)


Estimated Enrollment: 103
Study Start Date: June 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Procedure: Microfracture
Active control
Other Name: Conventional surgical 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626677

Contacts
Contact: Won-il Oh, MD, PhD +82-3465-6670 wioh@medi-post.co.kr
Contact: Young-Jin Heo +82-3465-6746 hyj@medi-post.co.kr

Locations
Korea, Republic of
Gachon University Gil Hospital Recruiting
Incheon, Korea, Republic of, 405-760
Principal Investigator: Beom-gu Lee, MD, PhD         
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 400-711
Principal Investigator: Myung-ku Kim, MD, PhD         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135-720
Principal Investigator: Jong-hyuk Choi, MD, PhD         
Kangbuk Samsung Hospital Not yet recruiting
Seoul, Korea, Republic of, 110-746
Principal Investigator: Hwa-jae Jeong, MD, PhD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Principal Investigator: Chul-won Ha, MD, PhD         
Principal Investigator: Young-Cheol Yoon, MD, PHD         
Seoul Veterans Hospital Recruiting
Seoul, Korea, Republic of, 134-060
Principal Investigator: Jung-ro Yoon, MD, PhD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Principal Investigator: Seong-il Bin, MD, PhD         
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of, 158-710
Principal Investigator: Jae-doo Yoo, MD, PhD         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 152-703
Principal Investigator: Hong-chul Lim, MD, PhD         
Hanyang University Medical Center Recruiting
Seoul, Korea, Republic of, 133-792
Principal Investigator: Choong-hyuk Choi, MD, PhD         
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 Hospital
Principal Investigator: Jong-hyeok Choi, MD, PhD Gangnam Severance Hospital
Principal Investigator: Hwa-jae Jeong, MD, PhD Kangbuk Samsung Medical center
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

Additional Information:
No publications provided

Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT01626677     History of Changes
Obsolete Identifiers: NCT01923532
Other Study ID Numbers: CARTISTEM_CR_F/U
Study First Received: June 19, 2012
Last Updated: November 1, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Medipost Co Ltd.:
Umbilical Cord Blood
Mesenchymal Stem Cells
Cartilage injury
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014