NCT04339504

Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial

Long-term Follow-up Study of Safety and Explore Efficacy in Subjects Who Completed SMUP-IA-01 Phase Ⅰ Clinical Trial

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Medipost Co Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a follow-up study to investigate the long-term safety and explore efficacy of SMUP-IA-01, for the treatment of Knee Osteoarthritis. Subjects who participated in and completed the initial stage of the Phase I trial (NCT04037345 ) will be followed-up until 60 months.

Detailed description

The subjects will be followed up at 6-month, 12-month, 24-month, 36-month, 48-month and 60-month after the initial administration of SMUP-IA-01.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	SMUP-IA-01(low-dose)	A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10\^6 cells/2mL)
BIOLOGICAL	SMUP-IA-01(mid-dose)	A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10\^7 cells/2mL)
BIOLOGICAL	SMUP-IA-01(high-dose)	A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10\^7 cells/2mL)

Timeline

• Start date: 2020-04-14
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-04-09
• Last updated: 2023-03-15

Locations

1 site across 1 country: South Korea