Stem Cells vs. Steroids for Discogenic Back Pain

• Status: Not yet recruiting
• Trial end date: 2025-11-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: The Geneva Foundation; United States Department of Defense
• Treatments: Anesthetics; Anesthetics, Local

Criteria

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