Status:
RECRUITING
The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-LDP) for Lumbar Discogenic Pain
Lead Sponsor:
Sclnow Biotechnology Co., Ltd.
Conditions:
Lumbar Discogenic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 experimen...
Detailed Description
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 experimen...
Eligibility Criteria
Inclusion
- age over 18
- refractory and persistent lumbago pain for more than 6 months, with/without radiation pain in lower limbs, and poor conservative treatment effect;
- the straight leg elevation test was 70 degrees negative;
- MRI of lumbar spine showed herniated disc \< 6 mm, no obvious compression of spinal cord and nerve roots; T2-weighted mri of the lumbar spine showed decreased single/multi-segment signal (black disc sign) or High signal zone (HIZ) in the posterior part of the intervertebral disc annulus.
- clinical signs of nerve localization were consistent with MRI changes;
- subject gives informed consent and signs informed consent.
Exclusion
- coagulation dysfunction or anticoagulant therapy;
- intervertebral space infection, puncture site infection or systemic infection;
- lumbago pain of non-spinal origin, such as sacroiliac joint origin pain;
- patients who have had open surgery or other disc treatments;
- imaging examination suggested disc prolapse, prolapse, spinal canal bone stenosis, etc.;
- patients with vital organ system dysfunction and tumor lumbar vertebra metastasis;
- subjects with high tumor markers (AFP/CEA/CA199/CA125);
- the subject is pregnant or breastfeeding;
- subjects also receive other treatments that may affect the efficacy and safety of stem cells;
- failing to control alcohol and other substance abuse during the 6 months prior to enrollment and enrollment period;
- the subjects suffer from mental illness, or lack of understanding, communication and cooperation, and cannot be guaranteed to follow the study protocol;
- Subjects who are not willing to sign informed consent and are participating in other clinical trials or have participated in other clinical trials within 3 months;
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT04104412
Start Date
August 15 2019
End Date
June 30 2026
Last Update
December 4 2025
Active Locations (1)
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1
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100053