Stem Cells vs. Steroids for Discogenic Back Pain

Not Applicable

Suspended

• Conditions: Chronic Low Back Pain; Degenerative Disc Disease
• Interventions: Other: Autologous stem cells; Drug: Corticosteroid; Drug: Local anesthetic

• Registration Number: NCT04735185
• Lead Sponsor: Johns Hopkins University

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 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).

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 with intradiscal steroids.

Up to 106 patients with a clinical diagnosis of chronic discogenic low back pain for greater than 6 months, MRI evidence of lumbar disc degeneration limited to one or two discs with \<50% disc height loss, and positive provocative discography (if clinically indicated) will be randomized to receive intradiscal BMC or steroid and long-acting local anesthetic (bupivacaine).

Those randomized to group I will receive a 2 mL intradiscal injection of autologous bone marrow-derived mesenchymal stem cells from bone marrow aspirate of the posterior ilium, while those randomized to group II will receive an intradiscal injection of the steroid methylprednisolone and the local anesthetic bupivacaine. The first follow-up will occur at 4-weeks post-treatment at which time rescue medications may be prescribed or adjusted but no other analgesic interventions should occur. The primary outcome measure will be pain relief at 3 months post-treatment, while a positive categorical outcome will be a 2-point or greater decrease in average LBP coupled with either a score \> 5/7 on the PGIC (indicating noticeable improvement) or a 10-point decrease in ODI (indicating a clinically meaningful benefit). At 3 months, a repeat MRI will be obtained in selected patients at military treatment facilities (i.e. every 5th patient). Those who fail to experience a positive categorical outcome will be withdrawn from the study to receive alternate care, including an option for intradiscal BMC in those who received corticosteroid. For those who continue to experience a positive outcome, there will be 6- and 12-month follow up visits. At all follow-up visits, histories and physical exams will be performed and questionnaires assessing sleep, function, and anxiety and depression will be administered.

Study Timeline

• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-02-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Study Start: 2025-09-30
• Primary Completion: 2025-11-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intradiscal autologous stem cells	Autologous stem cells	Participants in this arm will have autologous stem cells harvested through bone marrow aspiration. The stem cells that were harvested will be processed and injected into affected intradiscal spaces in the lumber spine.
Intradiscal corticosteroid and local anesthetic	Corticosteroid	Participants in this arm will receive an intradiscal injection of the steroid methylprednisolone and the local anesthetic bupivacaine into affected intradiscal spaces in the lumber spine.
Intradiscal corticosteroid and local anesthetic	Local anesthetic	Participants in this arm will receive an intradiscal injection of the steroid methylprednisolone and the local anesthetic bupivacaine into affected intradiscal spaces in the lumber spine.

Primary Outcome Measures

Name	Time	Method
Mean change in average low back pain score on 0-10 numerical rating scale	Baseline and 3 months	Mean change in average low back pain score over the past week at 3 months compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain)

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale score	1 year	14-question scale measuring anxiety and depression, with each question scored as 0-3 (higher numbers represent greater anxiety or depression).
Athens Insomnia Scale score	1 year	Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.
Patient global impression of change (PGIC) score	1 year	1-7 scale evaluating, with higher scores indicating greater improvement.
Oswestry disability index score	1 year	0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)
Mean change in worst low back pain score on 0-10 numerical rating scale	Baseline and 1 year	Mean change in worst low back pain score over the past week at week 1 year compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain).
Worst low back pain score on 0-10 numerical rating scale	12 months	Worst low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).
Positive categorical outcome	12 months	Greater or equal to 2-point decrease in average low back pain score coupled with a PGIC score of 5 or higher or a decrease on Oswestry disability score of 10 or greater
Disc Degeneration based on MRI	3 months	Disc degeneration on MRI (graded as significantly improved, slightly improved, no change, and worsening degeneration, based on Pfirmann's scale).
Average low back pain score on 0-10 numerical rating scale	1 year	Average low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States