Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects

This study is currently recruiting participants.
Verified July 2013 by Medipost Co Ltd.
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.
ClinicalTrials.gov Identifier:
NCT01733186
First received: November 20, 2012
Last updated: July 3, 2013
Last verified: July 2013

November 20, 2012
July 3, 2013
November 2012
January 2015   (final data collection date for primary outcome measure)
Number of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Physical examinations to assess swelling, tenderness, range of motion, and pain in the knee
  • Lab test and vital signs
Same as current
Complete list of historical versions of study NCT01733186 on ClinicalTrials.gov Archive Site
  • Improvement in IKDC score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Post-operative change in subjective knee function will be obtained from the IKDC score
  • Improvement in knee function and pain and grade of cartilage regeneration [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    • The Lysholm score and the KOOS score
    • Improvement degree of joint pain on a 100mm VAS
    • Grade of cartilage regeneration and morphological constitution of the cartilage repair area using MRI
  • Improvement in IKDC score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Post-operative change in subjective knee function will be obtained from the IKDC score
  • Improvement in knee function and pain and grade of cartilage regeneration [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    • The Lysholm score and the KOOS score
    • Improvement degree of joint pain on a 100mm VAS
    • Grade of cartilage regeneration and morphological constitution of the carilage repair area using MRI
Not Provided
Not Provided
 
Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects
Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects: A Phase I/IIa Clinical Trial in Patients With Focal, Full-thickness Grade 3-4 Articular Cartilage Defects of the Knee

The purpose of this study is to determine whether CARTISTEM, a cell therapeutic product, is safe and effective in the treatment of articular cartilage defects of the knee as a result of ageing, trauma, or degenerative diseases.

Conventional treatment modalities have not been able to provide complete and sustained resolution of symptoms following damage to the articular cartilage. Despite the numerous techniques available today, complete healing of damaged or defective cartilage or consistent reproduction of normal hyaline cartilage does not occur, and continuous drug administration or secondary surgeries are common.

Research in mesenchymal stem cells has had a rapid acceleration over the past decade and MSC-based therapy has become one of the objects of investigation for a new branch of medicine termed regenerative medicine. This emerging technology shows great promise for producing transplantable cartilage constructs to restore the function of degenerated joints.

CARTISTEM®, a combination of human umbilical cord blood-derived mesenchymal stem cells and sodium hyaluronate, is intended to be used as a single-dose cellular therapeutic agent for cartilage regeneration in human subjects with cartilage defects of the knee as a result of ageing, trauma, or degenerative diseases.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis,Degenerative,Traumatic Injury, Knee
Biological: CARTISTEM®
Other Name: human umbilical cord blood-derived mesenchymal stem cells
Experimental: CARTISTEM®
Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect
Intervention: Biological: CARTISTEM®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with an intended- to- treat single focal, full-thickness cartilage defect (ICRS [International Cartilage Repair Society] Grade 3 or 4) of the knee as a result of ageing, trauma, or degenerative diseases.
  • Age ≥ 18 years old
  • Size of the articular cartilage lesion is ≥ 2 cm2
  • Swelling, tenderness and active range of motion ≤ Grade II
  • Joint pain : 20-mm - 60-mm on VAS (Visual Analog Scale) at the time of Screening
  • Appropriate blood coagulation, kidney and liver function laboratory parameters: PT(INR) < 1.5, APTT <1.5×control Creatinine ≤ 2.0 mg/dL Albumin ≤ trace in urine dipstick test Bilirubin ≤ 2.0 mg/dL, AST/ALT ≤ 100 IU/L
  • Ligament instability ≤ Grade II
  • Lower extremity alignment within 5 degrees of the neutral weight bearing axis
  • No meniscal surgery within the past 3 months and more than 5mm of meniscal rim remaining
  • Ability and willingness to fully participate in the post-operative rehabilitation program
  • Subject is informed of the investigational nature of this study, voluntarily agrees to participate in the study, and signs an IRBapproved informed consent prior to performing any of the screening procedures
  • Body Mass Index (BMI) ≤ 35 kg/m2

Exclusion Criteria:

  • Patients who have been treated previously and are asymptomatic
  • Avascular necrosis/ osteonecrosis
  • Autoimmune or inflammatory joint disease
  • History of infection within the past 6 weeks
  • Surgery or radiation therapy within the past 6 weeks
  • Serious medical co-morbidities, which would otherwise contraindicate surgery, as determined by the investigator
  • Currently pregnant or nursing
  • Psychotic diseases, epilepsy, or any history of such diseases
  • Current abuse of alcohol (> 10 drinks weekly) and/or regular exposure to other substances of abuse, currently an active smoker
  • Chronic inflammatory articular diseases such as rheumatoid arthritis
  • Enrolled in any other clinical trials within the past 4 weeks
  • Administered immunosuppressants such as Cyclosporin A or azathioprine within the past 6 weeks
  • Ligament instability > Grade II
  • Uncorrected significant lower extremity malalignment (i.e. > 5 degrees)
  • (sub-) Total meniscectomy (<5mm rim remaining)
  • Corticosteroid or viscosupplementation injection to the affected knee in the past 3 months
  • Principal investigator considers inappropriate for the clinical trial due to any reasons other than those listed above
Both
18 Years and older
No
Contact: Wonil Oh, MD, PhD +82-2-3465-6670 wioh@medi-post.co.kr
United States
 
NCT01733186
MP-0201-01
Yes
Medipost Co Ltd.
Medipost Co Ltd.
Not Provided
Principal Investigator: Brian J Cole, MD Cartilage Restoration Center, Rush University Medical Center
Principal Investigator: Andreas H Gomoll, MD Cartilage Repair Center, Brigham and Women's Hospital
Medipost Co Ltd.
July 2013

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