NCT06589271

SCLife®-LDD hUC-MSCs Injection Therapy for Patients With Lumbar Intervertebral Disc Degeneration

A Clinical Research on SCLife®-LDD hUC-MSCs Injection Therapy for Patients With Lumbar Intervertebral Disc Degeneration

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sclnow Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Disc Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	human umbilical cord mesenchymal stem cell suspension	2 \* 10\^7 cells (2ml)
PROCEDURE	total endoscopic extraction of lumbar nucleus pulposus	hUC-MSCs are injected into the opposite side of the minimally invasive surgical site immediately after surgery, and the puncture needle remains for 1 minute after injection and then pull out to prevent cell suspension leakage

Timeline

• Start date: 2025-12-31
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-09-19
• Last updated: 2025-12-04

Locations

1 site across 1 country: China