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Mesenchymal Stem Cells for The Treatment of Knee Osteoarthritis (KOA).

NCT04893174 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-12-04

No results posted yet for this study

Summary

The clinical study with UMC119-06-05 is designed to investigate the safety in patients with mild to moderate knee osteoarthritis (KOA). This will be a dose escalation, open label, single-center study in adult with mild to moderate knee osteoarthritis. UMC119-06-05 is ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cells product which is intended for treatment of knee osteoarthritis.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

UMC119-06-05

Subjects will receive a single-dose IA injection of UMC119-06-05 followed by an IA injection of hyaluronic acid. Cohort 1: Low does UMC119-06-05 Cohort 2: High does UMC119-06-05

DEVICE

Hyaluronic acid

IA injection of hyaluronic acid.

Sponsors & Collaborators

  • Meridigen Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2024-09-30
Completion
2025-06-30

Countries

  • Taiwan

Study Locations

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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 NCT04893174 on ClinicalTrials.gov