Using stem cells from umbilical cords to treat lower back pain

The Safety/Efficacy Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Lumbar Discogenic Pain

This study is testing whether using stem cells from umbilical cords can help people with chronic lower back pain feel better.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 242 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sclnow Biotechnology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04104412 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of human umbilical cord mesenchymal stem cells in treating lumbar discogenic pain, specifically targeting patients with persistent back pain lasting over six months. Participants will undergo low-temperature plasma ablation and intravertebral disc injection of the stem cells, with evaluations conducted at multiple time points to assess outcomes. The study includes a control group for comparison and employs various safety assessments to monitor participants' health throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with refractory lower back pain for more than six months and specific MRI findings.

Not a fit: Patients with non-spinal origin pain or those who have undergone previous disc surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel and effective option for patients suffering from chronic lumbar discogenic pain.

How similar studies have performed: While the use of mesenchymal stem cells in other conditions has shown promise, this specific application for lumbar discogenic pain is relatively novel and not extensively tested.

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;

Where this trial is running

Beijing, Beijing Municipality

• Xuanwu Hospital Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jiaxiang Ni, Master

Conditions Lumbar Discogenic Pain; lumbar discogenic pain; mesenchymal stem cell