Trials / Active Not Recruiting
Active Not RecruitingNCT06798727
Evaluation Safety and Explore Efficacy Long-term Follow-up Study on Subjects Receiving SMUP-IA-01 or Active Control
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (actual)
- 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 II trial (NCT05182034) will be followed-up until 60 months.
Detailed description
The subjects will be followed up at 12-month, 24-month, 36-month, 48-month and 60-month after the initial administration of SMUP-IA-01.
Conditions
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) |
| DRUG | High Hyal Plus | A single knee administration of Hyaluronic acid(1% Sodium Hyaluronate 20mg/2ml) |
Timeline
- Start date
- 2023-03-20
- Primary completion
- 2027-03-20
- Completion
- 2027-11-30
- First posted
- 2025-01-29
- Last updated
- 2025-02-07
Locations
5 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06798727. Inclusion in this directory is not an endorsement.