NCT04037345

Evaluate Safety and Explore Efficacy of SMUP-IA-01 in Patients With Knee Osteoarthritis

A Open, Single-center, Phase 1 Trial to Evaluate Safety and Explore Efficacy of SMUP-IA-01 in Patients With Knee Osteoarthritis

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

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).

Detailed description

All subjects in each dose-group will visit 1 month\* (visit 5, 1 month±5 days) after administration of investigational product to evaluate dose limit toxicity (DLT) and determine whether to drop or proceed to next dose level. Total 5 visit (1week, 1 month, 2 months, 3 months, 6 months) until 6 months after administration of investigational product is planned to assess safety through vial sign, laboratory tests, and exploratory efficacy of IP will be assessed through Western Ontario and McMaster Universities osteoarthritis index (WOMAC), 100-mm visual analogue scale (VAS) and International Knee Documentation Committee (IKDC) subjective knee evaluation.

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: 2019-10-07
• Primary completion: 2020-11-12
• Completion: 2020-11-12
• First posted: 2019-07-30
• Last updated: 2021-02-24

Locations

1 site across 1 country: South Korea