Phase 2
N=12
Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects
Degeneration Articular Cartilage Knee
Bottom Line
View on ClinicalTrials.gov: NCT01733186 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: IKDC Score — 32.0; 25.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CARTISTEM® (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medipost, Inc.
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IKDC Score |
41.2; 27.5 | — |
| SECONDARY VAS |
-23.8; -12.5; -31.7; -11.3 | — |
| SECONDARY Lysholm Score |
26.7; 22.5; 32.0; 10.2 | — |
| SECONDARY KOOS Score |
28.2; 12.3; 23.6; 15.8; 50.0; 19.8 | — |
| SECONDARY IKDC Score |
41.2; 27.5 | — |
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.
Eligibility 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) 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
Data sourced from ClinicalTrials.gov (NCT01733186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.