Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278480
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2024-01-25
Brief Title:
Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti Application
Sponsor:
LC Bio
Organization:
LC Bio
Study Overview
Official Title:
Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti Application Multicenter Comparative Evaluator-blinded Retrospective Study
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 During the 48-week confirmatory clinical trial of MegaCarti patients who simultaneously underwent high tibial osteotomyHTO were treated with a group in which MegaCarti was implanted after microfracture and a group in which microfracture alone was performed Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None