NCT01626677

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Medipost Co Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Degenerative Osteoarthritis
• Defect of Articular Cartilage

Interventions

Type	Name	Description
BIOLOGICAL	CARTISTEM	A single dose of 500㎕/㎠ of cartilage defect
PROCEDURE	Microfracture	Active control

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2012-06-25
• Last updated: 2017-04-20

Locations

10 sites across 1 country: South Korea