Trials / Completed
CompletedNCT04310215
Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus
A Multi-center, Single-blind, Randomized, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Adding CARTISTEM® on Microfracture in Patients With Talar Chondral or Osteochondral Defect
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Hyundai Bioland Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-03-03
- Primary completion
- 2022-06-13
- Completion
- 2022-06-13
- First posted
- 2020-03-17
- Last updated
- 2022-11-29
Locations
6 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04310215. Inclusion in this directory is not an endorsement.