Stem Cells vs. Steroids for Discogenic Back Pain

NCT04735185 | Withdrawn DMC

• 1 other identifier: IRB00250806
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Low Back Pain; Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (33)

• Hospital Anxiety and Depression Scale score

  4 weeks

• Hospital Anxiety and Depression Scale score

  3 months

• Hospital Anxiety and Depression Scale score

  6 months

• Hospital Anxiety and Depression Scale score

  1 year

• Athens Insomnia Scale score

  4 weeks

Study Arms (2)

Intradiscal autologous stem cells

ACTIVE COMPARATOR

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

Intradiscal corticosteroid and local anesthetic

ACTIVE COMPARATOR

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; Drug: Local anesthetic

Interventions

Autologous stem cells OTHER

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.

Intradiscal autologous stem cells

Corticosteroid DRUG

In this intervention participants will receive a 1 mL intradiscal injection of the steroid methylprednisolone (40 mg/mL) into each affected disc.

Intradiscal corticosteroid and local anesthetic

Local anesthetic DRUG

In this intervention participants will receive a 1 mL intradiscal injection of the local anesthetic bupivacaine 0.5% into each affected disc.

Intradiscal corticosteroid and local anesthetic

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• The Geneva Foundation: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• 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.

  PMID: 25187512 BACKGROUND

• 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.

  PMID: 27661661 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Adrenal Cortex Hormones; Anesthetics, Local

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Steven Cohen, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We are trying to determine whether intradiscal injection of autologous BMC (bone marrow-derived mesenchymal stem cells) will decrease pain and improve function compared with intradiscal steroid.

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 3, 2021
• Study Start: September 30, 2025
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: For up to 3 years
• Access Criteria: Per approval by the funding organization (U.S. Department of Defense)

Locations

US (1)