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Intradiscal delivery of bone marrow concentrate (BMC) into discs, facet, epidural space, and sacroiliac joints
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem Cells (BMC) | Experimental | Subjects 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow Concentrate | Biological | The intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sairam Atluri, MD | Stem Cures | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stem Cures | Cincinnati | Ohio | 45230 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D055959 | Intervertebral Disc Degeneration |
| D011843 | Radiculopathy |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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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.
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Independent Observer was blinded as to wether a subject received treatment or was in the control group.
|
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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |