Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249828
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-25
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti in Knee Cartilage Defects
Sponsor:
LC Bio
Organization:
LC Bio
Study Overview
Official Title:
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:
RECRUITING
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:
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
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
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