Trials / Completed
CompletedNCT06249828
Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® in Knee Cartilage Defects
A Clinical Trial to Evaluate the Efficacy and Safety of Cartilage Regeneration in the Use of MegaCarti® in Patients With Knee Joint Cartilage Injury: Multicenter, Independent Evaluator-subject Blinded, Microfracture-comparative, Randomized Clinical Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- L&C Bio · Industry
- Sex
- All
- Age
- 50 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and MegaCarti® will be applied.
Detailed description
The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. To evaluate cartilage regeneration, the study group is compared with the microfracture group alone through MOCART evaluation at 48 weeks after treatment for cartilage regeneration. In addition, a biopsy is performed to evaluate the formation of hyaline cartilage and the area ratio of regenerated cartilage is measured.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MegaCarti® | MegaCarti® application after microfracture through athroscopic or incision surgery |
| PROCEDURE | Microfracture | Microfracture through athroscopic or incision surgery |
Timeline
- Start date
- 2024-01-22
- Primary completion
- 2025-12-13
- Completion
- 2025-12-13
- First posted
- 2024-02-08
- Last updated
- 2026-02-25
Locations
7 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06249828. Inclusion in this directory is not an endorsement.