Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects
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.
Degeneration Articular Cartilage Knee
|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|
- Number of adverse events [ Time Frame: 12 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
- Improvement in IKDC score [ Time Frame: 12 months ] [ 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: 12 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
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
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
Other Name: human umbilical cord blood-derived mesenchymal stem cells
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733186
|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|
|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|