MedTrace Logo

Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus

NCT04310215 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2022-11-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of adding CARTISTEM®(allogenic umbilical cord blood-derived stem cell product) on microfracture, a currently standard treatment for OLT, in patients with talar chondral or osteochondral defect.

Conditions

  • Chondral or Osteochondral Lesion of Talus

Interventions

BIOLOGICAL

CARTISTEM®

\*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠ 1. Procedure: Microfracture 2. Biological: CARTISTEM®(Human Umbilical Cord Blood-derived Mesenchymal Stem Cell product)

PROCEDURE

Microfracture

\*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠ 1\. Procedure: Microfracture

Sponsors & Collaborators

  • Medipost Co Ltd.

    collaborator INDUSTRY

  • Hyundai Bioland Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2022-06-13
Completion
2022-06-13

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT04310215 on ClinicalTrials.gov