Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589271
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
SCLife-LDD hUC-MSCs Injection Therapy for Patients With Lumbar Intervertebral Disc Degeneration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Research on SCLife-LDD hUC-MSCs Injection Therapy for Patients With Lumbar Intervertebral Disc Degeneration
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In recent years total endoscopic extraction of nucleus pulposus has been widely used in the treatment of lumbar disc herniation due to its advantages of less trauma faster recovery and less cost However the residual nucleus pulposus may protrude again after extraction and the stability of the operative segment decreases and the degeneration of the diseased segment accelerates Therefore while decompression of nerve root is completed under total endoscopic nucleus pulposus extraction tissue engineering of nucleus pulposus is urgently needed to replace the lost part repair the remaining nucleus pulposus and enable the disc to be re-sealed and pressurized Nucleus pulposus tissue engineering is mainly based on cell therapy and the corresponding biological scaffolds are selected to transplant cells into the diseased area for treatment However the current nuclear tissue engineering has some shortcomings such as limited seed cell source difficult survival of seed cells inflammatory rejection in the transplantation area poor mechanical properties of biological scaffolds poor degradation performance and inability to produce biospecific reactions between materials and cells which seriously restrict the clinical application of nuclear tissue engineering Human umbilical cord mesenchymal stem cells hUC-MSCs are ideal seed cells for the treatment of lumbar disc herniation due to their wide availability strong proliferation ability and good immune regulation Therefore in this project hUC-MSCs are used for cell transplantation into the vertebral disc of diseased vertebrae As the treatment method of this project is extremely minimally invasive it is conducive to the widespread promotion of the technology
Detailed Description:
In order to initially observe the safety and effectiveness of human umbilical cord mesenchymal stem cells hUC-MSCs transplantation in the treatment of lumbar disc degeneration this project planned to include a single group of 20 patients with lumbar disc herniation and adopt an open study design of non-random self-controlled single-dose group and locally inject 2mL hUcMSCs into the lumbar disc of enrolled patients
The patients were followed up 3 6 and 12 months after injection to evaluate the safety of hUC-MSCs Meanwhile the improvement of patients low back pain and quality of life were evaluated Lumbar MRI is used to evaluate the improvement of patients lumbar disc signal proving that hUC-MSCs transplantation can delay lumbar disc degeneration and treat lumbar degenerative diseases
The patients were followed up 3 6 and 12 months after injection to evaluate the safety of hUC-MSCs Meanwhile the improvement of patients low back pain and quality of life were evaluated Lumbar MRI is used to evaluate the improvement of patients lumbar disc signal proving that hUC-MSCs transplantation can delay lumbar disc degeneration and treat lumbar degenerative diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None