Stem Cells vs. Steroids for Discogenic Back Pain

Randomized, Comparative-effectiveness Study of Intradiscal Autologous Bone Marrow Concentrate Versus Intradiscal Corticosteroid for Chronic Discogenic Low Back Pain

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).

Study Overview

• Status: Withdrawn
• Conditions: Degenerative Disc Disease; Chronic Low Back Pain
• Intervention / Treatment: Other: Autologous stem cells; Drug: Corticosteroid; Drug: Local anesthetic

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intradiscal 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.	Other: Autologous stem cells; In this intervention participants will receive a 2 mL intradiscal injection into each affected disc of autologous bone marrow-derived mesenchymal stem cells from bone marrow aspirate of the posterior ilium.
Active Comparator: Intradiscal corticosteroid and 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.	Drug: Corticosteroid; In this intervention participants will receive a 1 mL intradiscal injection of the steroid methylprednisolone (40 mg/mL) into each affected disc.; Drug: Local anesthetic; In this intervention participants will receive a 1 mL intradiscal injection of the local anesthetic bupivacaine 0.5% into each affected disc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in average low back pain score on 0-10 numerical rating scale	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)	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient global impression of change (PGIC) score	1-7 scale evaluating, with higher scores indicating greater improvement.	4 weeks
Athens Insomnia Scale score	Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.	4 weeks
Hospital Anxiety and Depression Scale score	14-question scale measuring anxiety and depression, with each question scored as 0-3 (higher numbers represent greater anxiety or depression).	4 weeks
Hospital Anxiety and Depression Scale score	14-question scale measuring anxiety and depression, with each question scored as 0-3 (higher numbers represent greater anxiety or depression).	3 months
Hospital Anxiety and Depression Scale score	14-question scale measuring anxiety and depression, with each question scored as 0-3 (higher numbers represent greater anxiety or depression).	6 months
Hospital Anxiety and Depression Scale score	14-question scale measuring anxiety and depression, with each question scored as 0-3 (higher numbers represent greater anxiety or depression).	1 year
Athens Insomnia Scale score	Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.	3 months
Athens Insomnia Scale score	Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.	6 months
Athens Insomnia Scale score	Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.	1 year
Patient global impression of change (PGIC) score	1-7 scale evaluating, with higher scores indicating greater improvement.	3 months
Patient global impression of change (PGIC) score	1-7 scale evaluating, with higher scores indicating greater improvement.	6 months
Patient global impression of change (PGIC) score	1-7 scale evaluating, with higher scores indicating greater improvement.	1 year
Oswestry disability index score	0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)	4 weeks
Oswestry disability index score	0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)	3 months
Oswestry disability index score	0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)	6 months
Oswestry disability index score	0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)	1 year
Disc Degeneration based on MRI	Disc degeneration on MRI (graded as significantly improved, slightly improved, no change, and worsening degeneration, based on Pfirmann's scale).	3 months
Average low back pain score on 0-10 numerical rating scale	Average low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).	4 weeks
Average low back pain score on 0-10 numerical rating scale	Average low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).	3 months
Average low back pain score on 0-10 numerical rating scale	Average low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).	6 months
Average low back pain score on 0-10 numerical rating scale	Average low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).	1 year
Mean change in worst low back pain score on 0-10 numerical rating scale	Mean change in worst low back pain score over the past week at week 4 compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain).	Baseline and 4 weeks
Mean change in worst low back pain score on 0-10 numerical rating scale	Mean change in worst low back pain score over the past week at week 3 months compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain).	Baseline and 3 months
Mean change in worst low back pain score on 0-10 numerical rating scale	Mean change in worst low back pain score over the past week at week 6 months compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain).	Baseline and 6 months
Mean change in worst low back pain score on 0-10 numerical rating scale	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).	Baseline and 1 year
Worst low back pain score on 0-10 numerical rating scale	Worst low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).	4 weeks
Worst low back pain score on 0-10 numerical rating scale	Worst low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).	3 months
Worst low back pain score on 0-10 numerical rating scale	Worst low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).	6 months
Worst low back pain score on 0-10 numerical rating scale	Worst low back pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain).	12 months
Positive categorical outcome	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	4 weeks
Positive categorical outcome	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	3 months
Positive categorical outcome	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	6 months
Positive categorical outcome	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	12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: United States Department of Defense; The Geneva Foundation
• Investigators: Principal Investigator: Steven Cohen, MD, Johns Hopkins University

Publications and helpful links

General Publications

• Pettine KA, Murphy MB, Suzuki RK, Sand TT. Percutaneous injection of autologous bone marrow concentrate cells significantly reduces lumbar discogenic pain through 12 months. Stem Cells. 2015 Jan;33(1):146-56. doi: 10.1002/stem.1845.
• Noriega DC, Ardura F, Hernandez-Ramajo R, Martin-Ferrero MA, Sanchez-Lite I, Toribio B, Alberca M, Garcia V, Moraleda JM, Sanchez A, Garcia-Sancho J. Intervertebral Disc Repair by Allogeneic Mesenchymal Bone Marrow Cells: A Randomized Controlled Trial. Transplantation. 2017 Aug;101(8):1945-1951. doi: 10.1097/TP.0000000000001484.

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2025
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration; Physiological Effects of Drugs; Peripheral Nervous System Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Central Nervous System Agents; Anesthetics, Local; Adrenal Cortex Hormones
• Other Study ID Numbers: IRB00250806

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will be available upon request per approval of the U.S. Department of Defense (DoD).
• IPD Sharing Time Frame: For up to 3 years
• IPD Sharing Access Criteria: Per approval by the funding organization (U.S. Department of Defense)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No