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Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial

NCT04339504 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-03-15

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 I trial (NCT04037345 ) 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)

BIOLOGICAL

SMUP-IA-01(high-dose)

A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10\^7 cells/2mL)

Sponsors & Collaborators

  • Medipost Co Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-14
Primary Completion
2025-12-31
Completion
2025-12-31

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 NCT04339504 on ClinicalTrials.gov