Using stem cells from umbilical cords to treat lower back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Xuanwu Hospital Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jiaxiang Ni, Master
• Email: nijiaxiang@yahoo.com
• Phone: 8613910743476

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.