Stem Cells vs. Steroids for Discogenic Back Pain (NCT04735185) | Clinical Trial Compass
WithdrawnNot Applicable
Stem Cells vs. Steroids for Discogenic Back Pain
Stopped: Change in protocol per FDA that required funding and logistics that could not be accommodated.
United States0Started 2025-09-30
Plain-language 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 back pain (LBP). The primary objective of this study is to determine whether intradiscal autologous stem cells (from bone marrow aspirate) is more effective than intradiscal steroids for the treatment of chronic discogenic low back pain (LBP). Participants in this study will be randomized to receive up to intradiscal stem cell injections at 1 or 2 discs with cells harvested from a bone marrow aspirate drawn from participants' iliac crest, or an equal volume (2 mL) of intradiscal steroids and local anesthetic injected into the discs. In order to identify the painful disc(s), discography may be used at the discretion of the provider. Both treatments are frequently used as part of clinical care (i.e. there is no placebo group).
Who can participate
Age range18 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✕. 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