Chronic Low Back PainNCT04735185
Stem Cells vs. Steroids for Discogenic Back Pain
A study testing Autologous stem cells, Corticosteroid and Local anesthetic in people with Chronic Low Back Pain and Degenerative Disc Disease, run by Johns Hopkins University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Low Back Pain, Degenerative Disc Disease
- What is being tested?
- Autologous stem cells, Corticosteroid and Local anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Chronic Low Back Pain, Degenerative Disc Disease
- Being tested
- Autologous stem cells, Corticosteroid, Local anesthetic
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous stem cellsOther
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.
CorticosteroidDrug
In this intervention participants will receive a 1 mL intradiscal injection of the steroid methylprednisolone (40 mg/mL) into each affected disc.
Local anestheticDrug
In this intervention participants will receive a 1 mL intradiscal injection of the local anesthetic bupivacaine 0.5% into each affected disc.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Corticosteroid; Drug: Local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and 3 months
Secondary outcomes (33)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 year
Athens Insomnia Scale score
Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.
Measured: 4 weeks
Athens Insomnia Scale score
Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.
Measured: 3 months
Athens Insomnia Scale score
Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.
Measured: 6 months
Athens Insomnia Scale score
Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.
Measured: 1 year
Patient global impression of change (PGIC) score
1-7 scale evaluating, with higher scores indicating greater improvement.
Measured: 4 weeks
Patient global impression of change (PGIC) score
1-7 scale evaluating, with higher scores indicating greater improvement.
Measured: 3 months
Patient global impression of change (PGIC) score
1-7 scale evaluating, with higher scores indicating greater improvement.
Measured: 6 months
Patient global impression of change (PGIC) score
1-7 scale evaluating, with higher scores indicating greater improvement.
Measured: 1 year
Oswestry disability index score
0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)
Measured: 4 weeks
Oswestry disability index score
0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)
Measured: 3 months
Oswestry disability index score
0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)
Measured: 6 months
Oswestry disability index score
0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start30 Sep 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2028 (estimated)
Why it stopped: Change in protocol per FDA that required funding and logistics that could not be accommodated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- The Geneva Foundation, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Steven Cohen, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735185
- Sponsor's protocol ID
- IRB00250806
- Status last verified
- Oct 2025
- First submitted
- 28 Jan 2021
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be available upon request per approval of the U.S. Department of Defense (DoD).
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.
PubMed 25187512Noriega 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.
PubMed 27661661
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Comparative-effectiveness Study of Intradiscal Autologous Bone Marrow Concentrate Versus Intradiscal Corticosteroid for Chronic Discogenic Low Back Pain
- ClinicalTrials.gov ID
- NCT04735185
- Acronym / sponsor ID
- IRB00250806
- Conditions
- Chronic Low Back Pain, Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in protocol per FDA that required funding and logistics that could not be accommodated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- The Geneva Foundation, United States Department of Defense
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intradiscal autologous stem cells | Active comparator | Other: Autologous stem cellsParticipants 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 | Active comparator | Drug: Corticosteroid, Drug: Local anestheticParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous stem cellsIn 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. | Other | Intradiscal autologous stem cells |
| CorticosteroidIn this intervention participants will receive a 1 mL intradiscal injection of the steroid methylprednisolone (40 mg/mL) into each affected disc. | Drug | Intradiscal corticosteroid and local anesthetic |
| Local anestheticIn this intervention participants will receive a 1 mL intradiscal injection of the local anesthetic bupivacaine 0.5% into each affected disc. | Drug | Intradiscal corticosteroid and local anesthetic |
Primary outcome
Mean change in average low back pain score on 0-10 numerical rating scale
Time frame: 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)
33 secondary outcomes
Hospital Anxiety and Depression Scale score
Time frame: 4 weeks
Hospital Anxiety and Depression Scale score
Time frame: 3 months
Hospital Anxiety and Depression Scale score
Time frame: 6 months
Hospital Anxiety and Depression Scale score
Time frame: 1 year
Athens Insomnia Scale score
Time frame: 4 weeks
Athens Insomnia Scale score
Time frame: 3 months
Athens Insomnia Scale score
Time frame: 6 months
Athens Insomnia Scale score
Time frame: 1 year
Patient global impression of change (PGIC) score
Time frame: 4 weeks
Patient global impression of change (PGIC) score
Time frame: 3 months
Patient global impression of change (PGIC) score
Time frame: 6 months
Patient global impression of change (PGIC) score
Time frame: 1 year
Oswestry disability index score
Time frame: 4 weeks
Oswestry disability index score
Time frame: 3 months
Oswestry disability index score
Time frame: 6 months
Oswestry disability index score
Time frame: 1 year
Disc Degeneration based on MRI
Time frame: 3 months
Average low back pain score on 0-10 numerical rating scale
Time frame: 4 weeks
Average low back pain score on 0-10 numerical rating scale
Time frame: 3 months
Average low back pain score on 0-10 numerical rating scale
Time frame: 6 months
Average low back pain score on 0-10 numerical rating scale
Time frame: 1 year
Mean change in worst low back pain score on 0-10 numerical rating scale
Time frame: Baseline and 4 weeks
Mean change in worst low back pain score on 0-10 numerical rating scale
Time frame: Baseline and 3 months
Mean change in worst low back pain score on 0-10 numerical rating scale
Time frame: Baseline and 6 months
Mean change in worst low back pain score on 0-10 numerical rating scale
Time frame: Baseline and 1 year
Worst low back pain score on 0-10 numerical rating scale
Time frame: 4 weeks
Worst low back pain score on 0-10 numerical rating scale
Time frame: 3 months
Worst low back pain score on 0-10 numerical rating scale
Time frame: 6 months
Worst low back pain score on 0-10 numerical rating scale
Time frame: 12 months
Positive categorical outcome
Time frame: 4 weeks
Positive categorical outcome
Time frame: 3 months
Positive categorical outcome
Time frame: 6 months
Positive categorical outcome
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Background: PubMed 25187512Pettine 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.
- Background: PubMed 27661661Noriega 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.
- Individual participant dataSharing planned: Yes. Will be available upon request per approval of the U.S. Department of Defense (DoD).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Cohen, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous stem cells, Corticosteroid and Local anesthetic in people with Chronic Low Back Pain and Degenerative Disc Disease, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in average low back pain score on 0-10 numerical rating scale (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735185, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025; AzTrials last refreshed its copy on 28 Oct 2026.