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

NCT04037345 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-02-24

No results posted yet for this study

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).

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
2019-10-07
Primary Completion
2020-11-12
Completion
2020-11-12

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 NCT04037345 on ClinicalTrials.gov