NCT04104412 The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-LDP) for Lumbar Discogenic Pain
| NCT ID | NCT04104412 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sclnow Biotechnology Co., Ltd. |
| Condition | Lumbar Discogenic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 242 participants |
| Start Date | 2019-08-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 242 participants in total. It began in 2019-08-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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;
Contact & Investigator
Yuanzhang Tang, Doctor
STUDY DIRECTOR
Xuanwu Hospital, Beijing
Frequently Asked Questions
Who can join the NCT04104412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lumbar Discogenic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04104412 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04104412 currently recruiting?
Yes, NCT04104412 is actively recruiting participants. Contact the research team at nijiaxiang@yahoo.com for enrollment information.
Where is the NCT04104412 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04104412 clinical trial?
NCT04104412 is sponsored by Sclnow Biotechnology Co., Ltd.. The principal investigator is Yuanzhang Tang, Doctor at Xuanwu Hospital, Beijing. The trial plans to enroll 242 participants.