Low Back PainPhase 2/3NCT04559295
Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs
A Phase 2/3 study testing Bone Marrow Concentrate in people with Low Back Pain and Disc Disease, run by Stem Cures at 1 site in United States.
Trial summary
Intradiscal delivery of bone marrow concentrate (BMC) into discs, facet, epidural space, and sacroiliac joints Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain, Disc Disease, Disc Degeneration
- What is being tested?
- Bone Marrow Concentrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2018to 30 Apr 2021
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without protrusions/herniations and facet/sacroiliac joint pain
- Patients with mild to severe spinal stenosis
- Patients with radiculopathy
- Patients with disc extrusions
- Patients with failed spinal fusion
- Patients with mild to severe facet arthropathy
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- Patients with suspected sacroiliac joint disease
- Age 18 to 60 years
- Mild to severe loss of intervertebral disc height
- Pain is not responsive to conservative treatment measures (oral medication, epidural steroid injections, physical therapy)
- Pain persists for an extended period of time (i.e., at least 3 months)
- High intensity zone (HIZ) in annular fissure or adjacent to annular fissure detected on T2 or STIR MRI
- No evidence of contraindications to undergo procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer
- English speaking
Who cannot join
- Spinal Deformity (Scoliosis >20 degrees, Spondylolisthesis)
- Sequestered fragments, severe thecal sac compression
- Severe neurologic deficit
- Non-English speaking
- Bone marrow disorders
- Immunosuppressed Patients
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- Patients with coagulopathy
- Localized infection in the area of skin penetration
- Spinal infection
- Serious medical co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Bone of Marrow Concentrate (BMC) Injection in Discs, Facets, Sacroiliac Joints, and Epidural Space for Chronic Lower Back Pain With and Without Radiculopathy
Intradiscal delivery of bone marrow concentrate (BMC) into discs, facet, epidural space, and sacroiliac joints
Read the detailed description
To study if the outcomes for the injection of bone marrow concentrate (BMC) in patients with disc, facet, epidural space, and sacroiliac joint pain create a clinically meaningful improvement in pain and function. Further analysis will determine if there be any variance in patient reported outcome due to the individual's pre-procedure cell count and analysis.
Hypothesis 1: An injection of autologous BMC into discs, facets, sacroiliac joints, and epidural space will improve pain and function in patients with IDD
Hypothesis 2: There will be a direct relationship between an individual's BMC composition and the patient's reported outcomes
- Conditions
- Low Back Pain, Disc Disease, Disc Degeneration, Arthropathy Vertebrae, Sacral Disorder, Radiculopathy
- Being tested
- Bone Marrow Concentrate
- Keywords
- Stem cells, Bone marrow concentrate, Disc, Minimally invasive, Injections, Facet joint, Sacroiliac joint, Epidural space
- Medical subject headings
- Low Back Pain, Intervertebral Disc Degeneration, Radiculopathy, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow ConcentrateBiological
Also called Stem Cells
The intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints
| Study group | Role | What they receive |
|---|---|---|
| Stem Cells (BMC) | Experimental | Subjects in the BMC arm received an injection of bone marrow concentrate Receives: Biological: Bone Marrow Concentrate |
| Control | No intervention | Subjects in the control arm received no treatment for their condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst).
Measured: Two Years
Secondary outcomes (7)
Numeric Rating Scale (NRS)
The NRS consists of a numeric version of the visual analog scale. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. Scale for NRS is from 0 (best) - 10 (worst).
Measured: Two Years
Visual Analog Scale (VAS) for back pain
When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for back pain is from 0 (best) - 10 (worst).
Measured: Two Years
Visual Analog Scale (VAS) for leg pain
When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for leg pain is from 0 (best) - 10 (worst).
Measured: Two Years
PROMIS Physical Health
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Physical Health is from 16.2 (worst) - 67.7 (best)
Measured: Two Years
PROMIS Mental Health
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Mental Health is from 21.2 (worst) - 67.6 (best).
Measured: Two Years
North American Spine Society (NASS) for patient satisfaction
The North American Spine Society (NASS) developed an outcome assessment instrument to measure diverse dimensions of the impact of lumbar spine problems. Scale range is from 1 to 4 (best to worst).
Measured: Two Years
EURO Quality of Life (EuroQol)
EuroQol is an instrument which evaluates the generic quality of life developed in Europe and widely used. Scale is from 0.33 (worst - 0.88 (best).
Measured: Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start21 Nov 2018
- Primary completion19 Mar 2020
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A prospective evaluation of a cohort of patients with a specific characteristic over time to see if they develop a particular endpoint or outcome based on a stated hypothesis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stem Cures
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sairam Atluri, MD, Principal investigator, Stem Cures
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559295
- Sponsor's protocol ID
- Regen_003-1018
- Status last verified
- Sep 2020
- First submitted
- 31 Aug 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Bone of Marrow Concentrate (BMC) Injection in Discs, Facets, Sacroiliac Joints, and Epidural Space for Chronic Lower Back Pain With and Without Radiculopathy
- ClinicalTrials.gov ID
- NCT04559295
- Acronym / sponsor ID
- Regen_003-1018
- Conditions
- Low Back Pain, Disc Disease, Disc Degeneration, Arthropathy Vertebrae, Sacral Disorder, Radiculopathy
- Keywords
- Stem cells, Bone marrow concentrate, Disc, Minimally invasive, Injections, Facet joint, Sacroiliac joint, Epidural space
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Stem CuresUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 22 Sep 2020 (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.
Intradiscal delivery of bone marrow concentrate (BMC) into discs, facet, epidural space, and sacroiliac joints
Detailed description
To study if the outcomes for the injection of bone marrow concentrate (BMC) in patients with disc, facet, epidural space, and sacroiliac joint pain create a clinically meaningful improvement in pain and function. Further analysis will determine if there be any variance in patient reported outcome due to the individual's pre-procedure cell count and analysis.
Hypothesis 1: An injection of autologous BMC into discs, facets, sacroiliac joints, and epidural space will improve pain and function in patients with IDD
Hypothesis 2: There will be a direct relationship between an individual's BMC composition and the patient's reported outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective evaluation of a cohort of patients with a specific characteristic over time to see if they develop a particular endpoint or outcome based on a stated hypothesis.
| Arm | Type | Receives |
|---|---|---|
| Stem Cells (BMC) | Experimental | Biological: Bone Marrow ConcentrateSubjects in the BMC arm received an injection of bone marrow concentrate |
| Control | No intervention | –Subjects in the control arm received no treatment for their condition |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without protrusions/herniations and facet/sacroiliac joint pain
- Patients with mild to severe spinal stenosis
- Patients with radiculopathy
- Patients with disc extrusions
- Patients with failed spinal fusion
Key exclusion criteria (10 listed)
- Spinal Deformity (Scoliosis >20 degrees, Spondylolisthesis)
- Sequestered fragments, severe thecal sac compression
- Severe neurologic deficit
- Non-English speaking
- Bone marrow disorders
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 |
|---|---|---|
| Bone Marrow ConcentrateAlso: Stem CellsThe intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints | Biological | Stem Cells (BMC) |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: Two Years
The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst).
7 secondary outcomes
Numeric Rating Scale (NRS)
Time frame: Two Years
Visual Analog Scale (VAS) for back pain
Time frame: Two Years
Visual Analog Scale (VAS) for leg pain
Time frame: Two Years
PROMIS Physical Health
Time frame: Two Years
PROMIS Mental Health
Time frame: Two Years
North American Spine Society (NASS) for patient satisfaction
Time frame: Two Years
EURO Quality of Life (EuroQol)
Time frame: Two Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
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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.
Sairam Atluri, MD principal investigator
Stem Cures
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bone Marrow Concentrate in people with Low Back Pain and Disc Disease, run by Stem Cures 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 14 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Sep 2020. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Oswestry Disability Index (ODI) (time frame: Two Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2020; AzTrials last refreshed its copy on 27 Oct 2026.