Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs

Study Overview
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Brief Summary
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Intradiscal delivery of bone marrow concentrate (BMC) into discs, facet, epidural space, and sacroiliac joints

Detailed Description
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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

Official Title
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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

Conditions
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Low Back Pain, Disc Disease, Disc Degeneration, Arthropathy Vertebrae, Sacral Disorder, Radiculopathy, Spinal Stenosis

Intervention / Treatment
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* Biological: Bone Marrow Concentrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: Spinal Deformity (Scoliosis >20 degrees, Spondylolisthesis) Sequestered fragments, severe thecal sac compression Severe neurologic deficit Non-English speaking Bone marrow disorders Immunosuppressed Patients Patients with coagulopathy Localized infection in the area of skin penetration Spinal infection Serious medical co-morbidities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cells (BMC)<br>Subjects in the BMC arm received an injection of bone marrow concentrate | Biological: Bone Marrow Concentrate<br>* The intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints<br>* Other names: Stem Cells;|
| No Intervention: Control<br>Subjects in the control arm received no treatment for their condition | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Two Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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) | 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). | 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). | 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). | Two Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem cells, Bone marrow concentrate, Disc, Minimally invasive, Injections, Facet joint, Sacroiliac joint, Epidural space