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Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect

Degenerative Osteoarthritis Clinical Trial

Official title:
Long Term Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee

Clinical Trial Summary

This is a long term follow-up study to investigate the safety and efficacy of CARTISTEM®, human umbilical cord blood-derived mesenchymal stem cells, in repair of cartilage injury or defects, compared with microfracture. Subjects who participated in and completed the Phase III trial (NCT01041001) will be tracked until the 60 month post-treatment timepoint.

Clinical Trial Description

This long term follow-up study is performed to assess the long-term safety and efficacy of CARTISTEM®, human umbilical cord blood-derived mesenchymal stem cells, in repair of cartilage injury or defects, compared with microfracture. Subjects, who were either administered CARTISTEM or treated with conventional microfracture in the primary phase III study (NCT01041001), will be further observed using various subjective knee assessments and MRI T2 mapping until the 60 month post-treatment timepoint. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01626677
Study type Interventional
Source Medipost Co Ltd.
Contact
Status Completed
Phase Phase 3
Start date June 2012
Completion date May 2015
View Details
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