Study to Compare Efficacy and Safety of Cartistem and Microfracture in Patients With Knee Articular Cartilage Injury

NCT01041001 | Completed Phase 3 DMC

• 1 other identifier: MP-CRP-005
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of the study is to assess and compare the safety and efficacy of the allogeneic-unrelated umbilical cord blood-derived mesenchymal stem cell product (Cartistem®) to that of a microfracture treatment in patients with articular cartilage defect or injury.

Conditions

Cartilage Injury; Osteoarthritis

Keywords

Umbilical Cord Blood; Mesenchymal Stem Cells; cartilage injury; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• ICRS Cartilage Repair Assessment will follow to determine the appropriate grade. The treatment will be considered efficacious if the ICRS grade drops by at least 1 grade or more from baseline to week 48.

  Week 0 and 48

Secondary Outcomes (5)

• Degree of improvement in the grade of joint pain measured on a 100-mm VAS (Visual Analogue Scale)

  Week 0, 2, 4, 8, 12, 24, 36 and 48

• Grade of cartilage regeneration in patients who agreed to a biopsy during arthroscopy at week 48

  Week 48

• Changes in WOMAC scores

  Week 0, 2,4,8,12,24,36 and 48

• Changes in IKDC Subjective Score

  Week 0, 2, 4, 8, 12, 24, 36 and 48

• ICRS scores

  Week 48

Study Arms (2)

Cartistem

EXPERIMENTAL

A single dose of 500㎕/㎠ of cartilage defect

Biological: Cartistem

Microfracture treatment

ACTIVE COMPARATOR

Procedure: Microfracture treatment

Interventions

Cartistem BIOLOGICAL

allogeneic-unrelated umbilical cord blood-derived mesenchymal stem cell product

Cartistem

Microfracture treatment PROCEDURE

Microfracture treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above

Sponsors & Collaborators

• Medipost Co Ltd.: lead

Study Sites (8)

Gachon University Gil Hospital

Incheon, Gyunggido, 405-760, South Korea

Location

Inha University Hospital

Incheon, 400-711, South Korea

Location

Hanyang University Medical Center

Seoul, 133-792, South Korea

Location

Seoul Veterans Hospital

Seoul, 134-060, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 158-710, South Korea

Location

Related Publications (1)

• Lim HC, Park YB, Ha CW, Cole BJ, Lee BK, Jeong HJ, Kim MK, Bin SI, Choi CH, Choi CH, Yoo JD; Cartistem Research Group; Yoon JR, Chung JY. Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cell Implantation Versus Microfracture for Large, Full-Thickness Cartilage Defects in Older Patients: A Multicenter Randomized Clinical Trial and Extended 5-Year Clinical Follow-up. Orthop J Sports Med. 2021 Jan 12;9(1):2325967120973052. doi: 10.1177/2325967120973052. eCollection 2021 Jan.

  PMID: 33490296 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Hong-chul Lim, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2009
• First Posted: December 30, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: April 20, 2017

Record last verified: 2012-04

Locations

KR (8)