Actively Recruiting
The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-LDP) for Lumbar Discogenic Pain
Led by Sclnow Biotechnology Co., Ltd. · Updated on 2026-04-23
242
Participants Needed
1
Research Sites
410 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This experimental use umbilical cord mesenchymal stem cells in treatment of the early stage of lumbar discogenic pain (endogenous pain of the disc) to evaluate its safety and efficacy. This experimental is mainly aimed at over 18years old people, regardless of gender, with refractory and persistent back pain for more than 6 months. The efficacy and safety of mesenchymal stem cells (MSCS) were evaluated by low-temperature plasma ablation and intravertebral disc injection, which were divided into treatment group and control group.
CONDITIONS
Official Title
The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-LDP) for Lumbar Discogenic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18
- Persistent and difficult-to-treat low back pain lasting more than 6 months, with or without pain radiating to the lower limbs
- Negative straight leg elevation test at 70 degrees
- MRI of lumbar spine showing herniated disc less than 6 mm without obvious spinal cord or nerve root compression
- T2-weighted MRI showing decreased signal (black disc sign) or High Intensity Zone (HIZ) in the posterior part of the intervertebral disc annulus
- Clinical signs of nerve localization consistent with MRI findings
- Signed informed consent
You will not qualify if you...
- Coagulation problems or on anticoagulant therapy
- Infection in intervertebral space, puncture site, or systemic infection
- Low back pain from non-spinal causes, such as sacroiliac joint pain
- Previous open surgery or other disc treatments
- Imaging showing disc prolapse, spinal canal bone stenosis, or similar conditions
- Dysfunction of vital organs or tumor metastasis to lumbar vertebrae
- Elevated tumor markers (AFP, CEA, CA199, CA125)
- Pregnant or breastfeeding
- Receiving other treatments that could affect stem cell therapy safety or efficacy
- Uncontrolled alcohol or substance abuse in the past 6 months
- Mental illness or inability to understand or cooperate with study procedures
- Unwillingness to sign informed consent or participation in other clinical trials within the last 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
Research Team
J
Jiaxiang Ni, Master
CONTACT
L
Lei Guo, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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