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

NCT05182034 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-02-05

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Medipost Co Ltd.

    lead INDUSTRY

Principal Investigators

  • Myungchul Lee, MD, PhD · Seoul National University Hospital

  • Chonghyuk Choi, MD, PhD · Severance Hospital

  • Chongbum Chang, MD, PhD · Seoul Nation University Bundang Hospital

  • Seungbum Han, MD, PhD · Korea University Anam Hospital

  • Sunghwan Kim, MD, PhD · Gangnam Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-24
Primary Completion
2023-10-17
Completion
2023-10-17

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05182034 on ClinicalTrials.gov