drugset / Trial / NCT04037345
Evaluate Safety and Explore Efficacy of SMUP-IA-01 in Patients With Knee Osteoarthritis
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This clinical trial is performed with patients with knee osteoarthritis who were radiologically diagnosed with Kellgren-Lawrence (K\&L) grade 2 or 3. Subjects who voluntarily signed consent form and met inclusion/exclusion criteria, were evaluated eligible and participated in this trial. Investigator selected knee to be evaluated (right or left) and administered investigational product to selected knee on Day 1. A total of 3 or 6 subjects will be enrolled in low-dose or mid-dose group each, and 6 subjects will be enrolled in high-dose group. The study used a dose escalation scheme (from low-dose to high-dose) to determine the maximum tolerated dose (MTD).
Timeline
- Start
- 2019-10-07
- Primary completion
- 2020-11-12
- Completion
- 2020-11-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SMUP-IA-01 | Cell therapy | 4e+06 cells | Other |
| Subject | SMUP-IA-01 | Cell therapy | 1e+07 cells | Other |
| Subject | SMUP-IA-01 | Cell therapy | 2e+07 cells | Other |