Status:
WITHDRAWN
Stem Cells vs. Steroids for Discogenic Back Pain
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
The Geneva Foundation
United States Department of Defense
Conditions:
Chronic Low Back Pain
Degenerative Disc Disease
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
This is a randomized, comparative-effectiveness study comparing intradiscal autologous stem cells (from bone marrow aspirate) to intradiscal corticosteroid for the treatment of chronic discogenic low ...
Detailed Description
In this study, the investigators are attempting to determine if intradiscal injection of autologous bone marrow-derived mesenchymal stem cells (BMC) will decrease pain and improve function compared wi...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Pain duration \> 6 months
- Failure of non-operative treatment \> 3 months
- Average pain score \> 4/10 over the past week
- 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
- Lumbar MRI within the last 18 months showing disc degeneration in \<= 2 lumbar discs; \<50% disc height loss in each disc
- Patient agrees to have disc injection(s) and no other low back interventional or pharmacological treatments for at least 3 months
- Patient agrees to be off all NSAIDs and corticosteroids from 2 weeks prior to and 3 months after the injection.
- Stable dose of analgesic medications for at least 2 weeks
Exclusion
- Previous disc directed therapy involving heat (e.g. Intradiscal electrothermal therapy (IDET), biacuplasty)
- Previous disc injection therapy in the last 3 months (e.g. corticosteroid, platelet rich plasma, stem cells)
- 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)
- Disc extrusion or symptomatic disc protrusion at affected level
- Untreated coagulopathy
- Allergy to contrast dye or local anesthetics
- Negative discography or discography showing \> 2 positive discs
- Pain \> 15 years in duration
- Opioid dose \> 30 mg oral morphine equivalents per day (patients may be tapered down or off opioids)
- Diffuse pain phenotype (e.g. diagnosis of fibromyalgia)
- Secondary gain (e.g. ongoing medical board or litigation related to injury)
- 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.
- Cannot read or understand English
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04735185
Start Date
September 30 2025
End Date
November 30 2028
Last Update
October 7 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287