Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400862
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-03-09
Brief Title:
Treating Patients With Traumatic Chondral Lesions With Autologous Bone Marrow Cells Derived Engineered Tissues - Engineered Osteochondral Tissue
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Treating Patients With Traumatic Chondral Lesions With Autologous Bone Marrow Cells Derived Engineered Tissues - Engineered Osteochondral Tissue
Status:
RECRUITING
Status Verified Date:
2024-05
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:
TCL-aMSC-eOCT
Brief Summary:
The objective of the study is to establish the safety profile of the autologous engineered osteochondral tissues eOCT in treating traumatic chondral lesions in patients
Detailed Description:
TCL-aMSC- eOCT is a single arm first-in-human trial designed to establish the safety profile of autologous tissue engineered osteochondral tissue eOCT in patients with traumatic chondral lesions Patient selection will base on medical records especially MRI results and other criteria Patient enrollment and informed consent will be conducted at the baseline visit In a pre-treatment visit bone marrow aspiration will be conducted to harvest autologous bone marrow for mesenchymal stemstromal cells MSCs isolation and subsequent eOCT manufacturing Cartilage lesion will be repaired in the treatment visit by delivering eOCT through arthroscopic surgery roughly 13 weeks after the pre-treatment visit Rehabilitation will be conducted post-implantation Multiple follow-up visits will be conducted up to 24 months post-implantation data including adverse events clinical and functional scoring and blood tests will be collected during each follow-up visit Radiological assessment such as magnetic resonance imaging MRI will be conducted regularly until the end of the study
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