Clinical Trials in China / NCT04104412
Recruiting
Phase 1
The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-LDP) for Lumbar Discogenic Pain
NCT04104412 · tracked via the Priya Life Science China tracker
Condition(s) studied
Lumbar Discogenic Pain
Investigational drug(s) / intervention(s)
human umbilical cord mesenchymal stem cell
human umbilical cord mesenchymal stem cell: 2\*10\^7
Study 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 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.
Eligibility
Inclusion Criteria:
1. age over 18
2. refractory and persistent lumbago pain for more than 6 months, with/without radiation pain in lower limbs, and poor conservative treatment effect;
3. the straight leg elevation test was 70 degrees negative;
4. 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.
5. clinical signs of nerve localization were consistent with MRI changes;
6. subject gives informed consent and signs informed consent.
Exclusion Criteria:
1. coagulation dysfunction or anticoagulant therapy;
2. intervertebral space infection, puncture site infection or systemic infection;
3. lumbago pain of non-spinal origin, such as sacroiliac joint origin pain;
4. patients who have had open surgery or other disc treatments;
5. imaging examination suggested disc prolapse, prolapse, spinal canal bone stenosis, etc.;
6. patients with vital organ system dysfunction and tumor lumbar vertebra metastasis;
7. subjects with high tumor markers (AFP/CEA/CA199/CA125);
8. the subject is pregnant or breastfeeding;
9. subjects also receive other treatments that may affect the efficacy and safety of stem cells;
10. failing to control alcohol and other substance abuse during the 6 months prior to enrollment and enrollment period;
11. 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;
Primary outcome measure(s)
- Validity evaluation by detection the change of the VAS pain score relief rate for Lumbar disc pain of participants in different time point and compare with the VAS pain score before treatment — 24 weeks
Recording the VAS scores at 3, 6, 12 and 24 weeks after the operation and compare with the VAS score before the operation. Pain relief rate =(VAS before treatment - VAS after treatment)/VAS before treatment ×100%. VAS scale Use a line with 10 centimeters long as a point between 1 and 10 0 points, no pain, no pain sensation; 1-3 points, mild pain, no effect 4-6 points, moderate pain, affecting work but not life; 7-10 points, severe pain, severe pain, affect work and life. Efficacy evaluation: more than 75% is the basic remission; 50%-75% is effective; 25%-50% effective; Less than 25% is invalid. e.g. the VAS score before the operation is 8, the score in the third week after operation is 6, the pain relief rate is (8-6)/8x 100%=14.3% the VAS score before the operation is 8, the score in the sixth week after operation is 3, the pain relief rate is (8-3)/8x 100%=62.5%
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Beijing | Beijing Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04104412 on ClinicalTrials.gov ↗ ← All trials in China