Could stem cells ease your aching back?
NCT ID NCT04104412
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether stem cells from umbilical cords can safely relieve chronic low back pain caused by damaged spinal discs. It involves 242 adults with persistent pain for over 6 months. Participants receive stem cells injected into the disc, and researchers track pain levels and disability over 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- human umbilical cord mesenchymal stem cells
- What this could lead to
- If it works, this could point toward a new way to treat chronic back pain without surgery or long-term painkillers.
- What could go wrong
- This is a very early Phase 1 trial, so it is mainly checking safety. The stem cells may not reduce pain, and there could be unknown side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 242 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2019
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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;
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Xuanwu Hospital Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100053, China
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