Long-term Follow-up Study of Safety and Explore Efficacy in Subjects Who Completed SMUP-IA-01 Phase Ⅰ Clinical Trial
Who is this study for? Patients who have been treated with either SMUP-IA-01 at least 6 months ago
What treatments are being studied? SMUP-IA-01
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase I clinical trial.
• Subjects who have been treated with either SMUP-IA-01 at least 6 months ago.
• Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.
Locations
Other Locations
Republic of Korea
Seoul national University Hospital
RECRUITING
Seoul
Contact Information
Primary
Eunyoung LEE
ley0113@medi-post.co.kr
82234656748
Backup
Jungjin Park
jjpark@medi-post.co.kr
82234656641
Time Frame
Start Date: 2020-04-14
Estimated Completion Date: 2025-12
Participants
Target number of participants: 12
Treatments
Experimental: SMUP-IA-01(low-dose)
A single knee administration of SMUP-IA-01 (low-dose, 4.0 x 10\^6 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)
Experimental: SMUP-IA-01(mid-dose)
A single knee administration of SMUP-IA-01 (mid-dose, 1.0 x 10\^7 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)
Experimental: SMUP-IA-01(high-dose)
A single knee administration of SMUP-IA-01 (high-dose, 2.0 x 10\^7 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)
Related Therapeutic Areas
Sponsors
Leads: Medipost Co Ltd.