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

April 18, 2017 updated by: Medipost Co Ltd.

Randomized, Open-Label, Multi-Center and Phase 3 Clinical Trial to Compare the Efficacy and Safety of Cartistem® and Microfracture in Patients With Knee Articular Cartilage Injury or Defect

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The cartilage is a unique avascular, aneural tissue that does not regenerate easily once damaged. Chondral defects or damages to articular cartilages due to accidents, necrosis of subchondral bone tissue, or arthritis have become some of the more common disorders today. About 15% of the world's population is reportedly suffering from cartilage and joint damages such as degenerative arthritis and rheumatoid arthritis. As population aging progresses and as more young people start taking up active sports, the size of the target patient group is also growing. However, despite ongoing research, an effective treatment for cartilage defects is yet to be discovered. Various different types of treatments are currently in use, such as drug therapy, arthroscopy, and artificial joint surgery. However, they all fail to address the root cause. Complete treatment, or regeneration of damaged or defective cartilage is impossible and continuous drug administration or secondary surgeries are required in many cases.

As a way of regenerating the damaged or defective cartilage tissue, treatment of localized damage to articular cartilage using autologous chondrocytes is currently under review. A few life science companies both home and abroad are marketing this method of treatment called 'autologous chondrocyte transplant'. The treatment involves the extraction of healthy cartilage tissue from the patient which is then cultured and transplanted into the damaged site.

However, this treatment requires the extraction of chondrocytes directly from the patient and thus causes trauma in healthy articular cartilage. Also, this type of treatment cannot be applied to large lesions, nor is the efficacy satisfactory in patients over the age of 40 whose cellular activation levels are low. Thus, autologous chondrocyte transplant is rather limited in the number of cells harvested and their activation level and is therefore restricted in terms of treatment site, severity of the condition, and the size of lesion. The current technology allows the application of treatments in local cartilage defects but not in degenerative arthritis or rheumatoid arthritis. The technology needs to be taken up to another level in order to benefit such prevalent arthritic disorders. Treatments using stem cells do not cause damage to healthy articular cartilage as they don't require the harvesting of healthy cartilage tissues from the patients. Moreover, the number of successfully cultured cells is larger due to the excellent proliferation capability of stem cells and thus, mass supply is possible.

This clinical trial for the stem cell therapies is essential because treatment of cartilage defects with umbilical cord blood-derived mesenchymal stem cells, known to have the highest level of activity among all adult stem cells, opens the possibility of articular cartilage regeneration even for aged patients and patients with large lesions unable to benefit from existing treatments.

The biggest challenge faced by nations competing in the field of "tissue differentiation and regeneration using stem cells" is the question of whether or not the use of embryonic stem cells is ethical. Chondrogenesis using umbilical cord blood-derived mesenchymal stem cells can not only avoid similar challenges, but also present an innovative treatment mode with significant clinical implications for the patients.

In the clinical study, mesenchymal stem cells will be isolated from umbilical cord blood and cultured, mixed with semi- solid polymer, and administered into the cartilage tissue lesion by orthopedic surgery in order to stimulate the regeneration of defective cartilage tissue and to improve their functions.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of, 400-711
        • Inha University Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 158-710
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 133-792
        • Hanyang University Medical Center
      • Seoul, Korea, Republic of, 134-060
        • Seoul Veterans Hospital
    • Gyunggido
      • Incheon, Gyunggido, Korea, Republic of, 405-760
        • Gachon University Gil Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cartistem
A single dose of 500㎕/㎠ of cartilage defect
Biological: Cartistem
allogeneic-unrelated umbilical cord blood-derived mesenchymal stem cell product
Active Comparator: Microfracture treatment
Procedure: Microfracture treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Week 0 and 48
Week 0 and 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Degree of improvement in the grade of joint pain measured on a 100-mm VAS (Visual Analogue Scale)
Time Frame: Week 0, 2, 4, 8, 12, 24, 36 and 48
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
Time Frame: Week 48
Week 48
Changes in WOMAC scores
Time Frame: Week 0, 2,4,8,12,24,36 and 48
Week 0, 2,4,8,12,24,36 and 48
Changes in IKDC Subjective Score
Time Frame: Week 0, 2, 4, 8, 12, 24, 36 and 48
Week 0, 2, 4, 8, 12, 24, 36 and 48
ICRS scores
Time Frame: Week 48
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipost Co Ltd.

Investigators

  • Principal Investigator: Hong-chul Lim, MD, PhD, Korea University Guro Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

December 29, 2009

First Submitted That Met QC Criteria

December 29, 2009

First Posted (Estimate)

December 30, 2009

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-CRP-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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