Back pain study pulled before it even started
NCT ID NCT04735185
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to compare two treatments for chronic low back pain caused by worn-out discs: injections of a person's own stem cells (from bone marrow) versus steroid injections. It planned to enroll adults with pain lasting over 6 months who had not improved with other treatments. However, the study was withdrawn before any participants were enrolled, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 to 100 years
- 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 ≥ 18 2. Pain duration \> 6 months 3. Failure of non-operative treatment \> 3 months 4. Average pain score \> 4/10 over the past week 5. Presumed clinical diagnosis of discogenic low back pain (such as back\>leg pain, no or minimal radiation of pain past knee level, no significant improvement with epidural steroid injection, facet injections, sacroiliac joint injections and/or trigger point injections 6. Lumbar MRI within the last 18 months showing disc degeneration in \<= 2 lumbar discs; \<50% disc height loss in each disc 7. Patient agrees to have disc injection(s) and no other low back interventional or pharmacological treatments for at least 3 months 8. Patient agrees to be off all NSAIDs and corticosteroids from 2 weeks prior to and 3 months after the injection. 9. Stable dose of analgesic medications for at least 2 weeks Exclusion Criteria: 1. Previous disc directed therapy involving heat (e.g. Intradiscal electrothermal therapy (IDET), biacuplasty) 2. Previous disc injection therapy in the last 3 months (e.g. corticosteroid, platelet rich plasma, stem cells) 3. Previous lumbar spine surgery (e.g. discectomy, fusion) at the affected levels (i.e. those with relief after surgery in whom adjacent segment discogenic pain is suspected can be considered on a case-by-case basis) 4. Disc extrusion or symptomatic disc protrusion at affected level 5. Untreated coagulopathy 6. Allergy to contrast dye or local anesthetics 7. Negative discography or discography showing \> 2 positive discs 8. Pain \> 15 years in duration 9. Opioid dose \> 30 mg oral morphine equivalents per day (patients may be tapered down or off opioids) 10. Diffuse pain phenotype (e.g. diagnosis of fibromyalgia) 11. Secondary gain (e.g. ongoing medical board or litigation related to injury) 12. Pregnancy (study subject report of negative pregnancy status will be sufficient to participate. Testing will be provided if subject is unsure or requests a test to confirm. 13. Cannot read or understand English
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
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Other studies related to the condition(s) this trial covers.
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