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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. Identifier: NCT01733186
Recruitment Status : Completed
First Posted : November 26, 2012
Last Update Posted : August 29, 2018
Information provided by (Responsible Party):
Medipost Co Ltd.

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.

Condition or disease Intervention/treatment Phase
Degeneration Articular Cartilage Knee Biological: CARTISTEM® Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 7, 2013
Actual Primary Completion Date : June 2, 2017
Actual Study Completion Date : August 29, 2017

Arm Intervention/treatment
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
Biological: CARTISTEM®
Other Name: human umbilical cord blood-derived mesenchymal stem cells

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Improvement in IKDC score [ Time Frame: 12 months ]
    Post-operative change in subjective knee function will be obtained from the IKDC score

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01733186

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United States, Illinois
Cartilage Restoration Center; RUSH University Medical Center
Chicago, Illinois, United States, 60612
United States, Massachusetts
Cartilage Repair Center; Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Medipost Co Ltd.
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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
Additional Information:
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Responsible Party: Medipost Co Ltd. Identifier: NCT01733186    
Other Study ID Numbers: MP-0201-01
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Medipost Co Ltd.:
human umbilical cord blood-derived mesenchymal stem cells
cartilage lesion
cartilage defect
degenerative arthritis
stem cell implantation
Additional relevant MeSH terms:
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Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases