Autologous Chondrocyte Implantation (CartiLife®) for Articular Cartilage Injury

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Articular Cartilage Injury+1 MoreAutologous Chondrocyte Implantation (CartiLife®) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a treatment for knee cartilage defects is safe and effective.

Eligible Conditions
  • Articular Cartilage Injury
  • Osteoarthritis

Treatment Effectiveness

Study Objectives

2 Primary · 13 Secondary · Reporting Duration: Week 0 (pre-operation), and up to 24 Months (post-operation)

Week 48
Knee
Cartilage
Week 8
Change in IKDC (International Knee Documentation Committee) Score
Knee
Knee
Change in Lysholm Score
Change in Tegner Activity Score
Change in VAS (100mm Pain Visual Analogue Scale)
Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Score
Change in pain medication dosage
Change in pain medication frequency
Month 24
Therapeutic procedure
Therapeutic procedure
Week 24
Evaluation of T2 mapping
Evaluations of MOCART Score

Trial Safety

Trial Design

2 Treatment Groups

Microfracture surgery
1 of 2
CartiLife®
1 of 2

Active Control

Experimental Treatment

25 Total Participants · 2 Treatment Groups

Primary Treatment: Autologous Chondrocyte Implantation (CartiLife®) · No Placebo Group · Phase 2

CartiLife®
Drug
Experimental Group · 1 Intervention: Autologous Chondrocyte Implantation (CartiLife®) · Intervention Types: Drug
Microfracture surgery
Procedure
ActiveComparator Group · 1 Intervention: Microfracture Surgery · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 0 (pre-operation), and up to 24 months (post-operation)

Who is running the clinical trial?

Biosolution Co., Ltd.Lead Sponsor
4 Previous Clinical Trials
159 Total Patients Enrolled
Jungsun Lee, Ph.DStudy DirectorBiosolution Co., Ltd.
1 Previous Clinical Trials
104 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female aged over 18 at the time of signing the Informed Consent form.
You have a subject with an isolated ICRS Grade III or IV chondral lesion on articular cartilage.
You are able to move independently and have a mechanically stable knee.
You have a meniscus injury that is >50% of the meniscus.
You agree to actively participate in a rehabilitation protocol and follow-up program.
You are able to provide informed consent and comply with study requirements.
You are willing to discontinue any NSAIDs except rescue medication 7 days prior to visit.
The subject has a size of the relevant cartilage lesion ≥ 2 cm2 and ≤ 10 cm2 but with a defect area total volume ≤ 4 cm3.