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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01733186
Recruitment Status : Completed
First Posted : November 26, 2012
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.

Tracking Information
First Submitted Date  ICMJE November 20, 2012
First Posted Date  ICMJE November 26, 2012
Last Update Posted Date August 29, 2018
Actual Study Start Date  ICMJE January 7, 2013
Actual Primary Completion Date June 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
Number of adverse events [ Time Frame: 12 months ]
  • Physical examinations to assess swelling, tenderness, range of motion, and pain in the knee
  • Lab test and vital signs
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2012)
Number of adverse events [ Time Frame: 24 months ]
  • Physical examinations to assess swelling, tenderness, range of motion, and pain in the knee
  • Lab test and vital signs
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
  • Improvement in IKDC score [ Time Frame: 12 months ]
    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: 12 months ]
    • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2012)
  • Improvement in IKDC score [ Time Frame: 24 weeks ]
    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 ]
    • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Degeneration Articular Cartilage Knee
Intervention  ICMJE Biological: CARTISTEM®
Other Name: human umbilical cord blood-derived mesenchymal stem cells
Study Arms  ICMJE 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®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2012)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 29, 2017
Actual Primary Completion Date June 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01733186
Other Study ID Numbers  ICMJE MP-0201-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Medipost Co Ltd.
Study Sponsor  ICMJE Medipost Co Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Medipost Co Ltd.
Verification Date August 2018

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