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 ST 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

June 19, 2012
November 1, 2013
June 2012
May 2015   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01626677 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Degenerative Osteoarthritis
  • Defect of Articular Cartilage
  • Biological: CARTISTEM
    A single dose of 500㎕/㎠ of cartilage defect
    Other Name: hUCB-MSCs
  • Procedure: Microfracture
    Active control
    Other Name: Conventional surgical treatment
  • Experimental: CARTISTEM
    A single dose of 500㎕/㎠ of cartilage defect
    Intervention: Biological: CARTISTEM
  • Active Comparator: Microfracture
    Intervention: Procedure: Microfracture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
103
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Korea, Republic of
 
NCT01626677
CARTISTEM_CR_F/U
Yes
Medipost Co Ltd.
Medipost Co Ltd.
Dong-A ST Co., Ltd.
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
Medipost Co Ltd.
November 2013

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