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

NCT06589271 | Suspended Phase 1

• 1 other identifier: SCLnow-SH-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Degeneration

Outcome Measures

Primary Outcomes (1)

• Change of lumbar disc MRI (T2WI) signal values

  Lumbar MRI images are taken on day 0-1 (measured before stem cell transplantation), 3 months, 6 months and 12 months to record the signal value of the intervertebral disc (4 times in total) from level IV-V to level III and below.

  12 months

Secondary Outcomes (3)

• Lower back pain and lower extremity radiating pain relief

  12 months

• X-ray Disc Height Index (DHI)

  12 months

• MRI highlights changes in the size of the nucleus pulposus

  12 months

Study Arms (2)

hUC-MSCs transplantation group

EXPERIMENTAL

Human Umbilical Cord Mesenchymal Stem Cells

Biological: human umbilical cord mesenchymal stem cell suspension

control group

ACTIVE COMPARATOR

suspension transplantation

Procedure: total endoscopic extraction of lumbar nucleus pulposus

Interventions

human umbilical cord mesenchymal stem cell suspension BIOLOGICAL

2 \* 10\^7 cells (2ml)

hUC-MSCs transplantation group

total endoscopic extraction of lumbar nucleus pulposus PROCEDURE

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

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-60 years old;
• The symptoms are lumbago combined with radiating pain of one lower limb;
• Failed conservative treatment for 3 months, including physical therapy, manual therapy and non-morphine drug therapy;
• CT/MRI clearly highlighted the nucleus pulposus pressing the nerve root and the location was consistent;
• Symptoms and imaging showed unilateral lumbar disc herniation;
• Imaging showed single-level lumbar disc herniation;
• MRI (T2WI) of Pfirrmann disc degeneration: Grade I-IV;
• Lumbar disc herniation segments: L3-4, L4-5, L5-S1;
• Unilateral full endoscopic extraction of nucleus pulposus;
• Sign the informed consent;
• No previous history of spinal surgery.

You may not qualify if:

• Previous history of tumor and spinal infection;
• Patients with severe coagulation disorders, a history of drug abuse or taking oral anticoagulants;
• Coma or incapacitation;
• MRI contraindications (history of cardiovascular and cerebrovascular stent implantation, pacemaker, biostimulator, etc.);
• Pregnant women;
• Pregnancy or breastfeeding;
• Have participated in other clinical trials related to this project within the past 30 days;
• Those who have received stem cell therapy;
• Poor compliance, or can not correctly understand the cooperation so that it can not complete the interview;
• Received intervertebral disc interventional therapy within the past 3 months, such as radiofrequency, laser ablation, protease injection, Ozone injection;
• Highly allergic or have a history of severe allergies;
• Patients with severe autoimmune disease or who are receiving immunosuppressive therapy;
• Serious uncontrolled infection or high fever;
• Patients with shock, failure of vital organs and unstable vital signs;
• X-ray showed that the degree of stenosis of the diseased segment was more than 30% compared with the adjacent normal segment;

Sponsors & Collaborators

• Sclnow Biotechnology Co., Ltd.: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, 200080, China

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: non-randomized, self-controlled, single-dose

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)