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Autologous Chondrocyte Implantation

CartiLife® for Osteoarthritis and Articular Cartilage Injury

Phase 2
Recruiting
Research Sponsored by Biosolution Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 (pre-operation), and up to 24 months (post-operation)
Awards & highlights

Study Summary

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

Eligible Conditions
  • Articular Cartilage Injury
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 (pre-operation), and up to 24 months (post-operation)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 (pre-operation), and up to 24 months (post-operation) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Knee
Cartilage
Secondary outcome measures
Change in IKDC (International Knee Documentation Committee) Score
Knee
Knee
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CartiLife®Experimental Treatment1 Intervention
Extracellular matrix-associated autologous chondrocytes comprise CartiLife®, composed as pellets (1.1 to 1.8 mm in diameter) in suspension. One pre-filled syringe is implanted per 1 cm3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy.

Find a Location

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

Media Library

Articular Cartilage Injury Research Study Groups: CartiLife®

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applications being accepted for this scientific trial at present?

"Per the information on clinicaltrials.gov, this medical trial is seeking patients at present. The study was initially published on October 28th 2020 and last modified on May 18th 2022."

Answered by AI

How pervasive is the implementation of this research within United States medical facilities?

"Currently, this clinical trial is running in 5 different medical centres - Columbus, Irvine and Lafayette are the primary sites with some other locations. To facilitate your participation in the research project, it's recommended to pick a site that's closest to you for reduced travel needs."

Answered by AI

What is the scope of participants in this research investigation?

"To partake in this medical trial, 25 individuals who meet the inclusionary conditions must be recruited. These patients can originate from Horizon Clinical Research of Columbus, Ohio or Ohio State University's Irvine facility in Louisiana."

Answered by AI

Has Autologous Chondrocyte Implantation (CartiLife®) attained FDA clearance?

"Autologous Chondrocyte Implantation (CartiLife®) was judged to be of a 2/3 level of safety because, while Phase 2 clinical trials have revealed data indicative of its security, there are yet to be any studies concerning the efficacy of such treatment."

Answered by AI

What outcome is the team striving for with this clinical experiment?

"According to data provided by the trial's sponsor, Biosolution Co., Ltd., their primary measure of efficacy is Change in volume fill of cartilage defect score. This will be monitored from Week 0 (pre-operation) to Week 48 (post-operation). Secondary outcomes include Change in Tegner Activity Score, Evaluations of MOCART Score and Number of subjects with treatment-emergent serious adverse events. All are assessed according to pre-defined criteria as outlined by Karen Hambly 2011 and Investigator judgement respectively."

Answered by AI

Who else is applying?

What state do they live in?
Arkansas
What site did they apply to?
Horizon Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Phase 2 Clinical Trial of CartiLife® in the United States
2020. "Phase 2 Clinical Trial of CartiLife® in the United States". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04744402.
~6 spots leftby Apr 2025
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