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Evaluation Safety and Explore Efficacy Long-term Follow-up Study on Subjects Receiving SMUP-IA-01 or Active Control

NCT06798727 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-02-07

No results posted yet for this study

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.

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

High Hyal Plus

A single knee administration of Hyaluronic acid(1% Sodium Hyaluronate 20mg/2ml)

Sponsors & Collaborators

  • Medipost Co Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2027-03-20
Completion
2027-11-30

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 NCT06798727 on ClinicalTrials.gov