Status:
SUSPENDED
SCLife®-LDD hUC-MSCs Injection Therapy for Patients With Lumbar Intervertebral Disc Degeneration
Lead Sponsor:
Sclnow Biotechnology Co., Ltd.
Conditions:
Lumbar Disc Degeneration
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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. Ho...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Imaging showed lumbar disc herniation complicated with calcification;
- Imaging showed lumbar disc herniation with Modic Change;
- Imaging showed lumbar disc herniation complicated with severe spinal stenosis;
- Imaging showed lumbar disc herniation complicated with lumbar spondylolisthesis;
- Imaging showed lumbar disc herniation combined with spinal deformity;
- Mental disorders, cognitive disorders, or other physical diseases affecting the research results;
- Doctors believe that there are other reasons for not being included in the treatment.
Key Trial Info
Start Date :
December 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06589271
Start Date
December 31 2025
End Date
December 31 2026
Last Update
December 4 2025
Active Locations (1)
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1
Shanghai General Hospital
Shanghai, China, 200080