NCT05182034

Clinical Trial to Evaluate Efficacy and Safety of SMUP-IA-01 in Patients With Knee Osteoarthritis

A Multi-center, Randomized, Double-Blinded, Active-Controlled, Phase II Clinical Trial to Evaluate Efficacy and Safety of SMUP-IA-01 in Patients With Knee Osteoarthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Medipost Co Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is for patients who have been diagnosed with Kellgren-Lawrence (K\&L) Grade 2 or 3 knee osteoarthritis on radiographic examination. Only subjects who voluntarily agree to participate by filling out the written Informed Consent document will undergo screening for subject selection (inclusion/exclusion) criteria, at which time the severity of OA in each knee will be used to determined which knee will be treated (index knee - i.e., the more severely affected knee), and enroll in this study.

Detailed description

Patients who meet the inclusion/exclusion criteria will be randomly assigned at visit 2 to either of study group 1(low-dose), study group 2 (mid-dose) or active control group at 1:1:1 ratio. Patients will be administered with investigational product. Investigational product will be administered into the to-be-treated (index) knee one time within 7 days after randomization. All patients enrolled will be followed up a total of 6 times (1, 4, 8, 12, 24, and 52 weeks) for up to post-dose 12 months. The patients should visit the study facility according to the visit schedule, and will undergo safety evaluation (vital sign, laboratory test, etc.) and efficacy evaluation \[Western Ontario and McMaster Universities osteoarthritis index (WOMAC), 100-mm visual analogue scale (VAS), International Knee Documentation Committee (IKDC) subjective knee evaluation\].

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)
DRUG	Active Control Group Sodium chloride	A single knee administration of Sodium chloride

Timeline

• Start date: 2022-02-24
• Primary completion: 2023-10-17
• Completion: 2023-10-17
• First posted: 2022-01-10
• Last updated: 2025-02-05

Locations

5 sites across 1 country: South Korea