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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention Phase
Osteoarthritis,Degenerative,Traumatic Injury, Knee
Biological: CARTISTEM®
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medipost Co Ltd.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 12
Study Start Date: November 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733186

Contacts
Contact: Wonil Oh, MD, PhD +82-2-3465-6670 wioh@medi-post.co.kr

Locations
United States, Illinois
Cartilage Restoration Center; RUSH University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Brian J Cole, MD         
United States, Massachusetts
Cartilage Repair Center; Brigham and Women's Hospital Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact       CRCStudy@partners.org   
Principal Investigator: Andreas H Gomoll, MD         
Sponsors and Collaborators
Medipost Co Ltd.
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT01733186     History of Changes
Other Study ID Numbers: MP-0201-01
Study First Received: November 20, 2012
Last Updated: July 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medipost Co Ltd.:
human umbilical cord blood-derived mesenchymal stem cells
MSC
cartilage lesion
cartilage defect
degenerative arthritis
stem cell implantation

Additional relevant MeSH terms:
Cartilage Diseases
Knee Injuries
Osteoarthritis
Wounds and Injuries
Arthritis
Connective Tissue Diseases
Joint Diseases
Leg Injuries
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014