Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs

Stem Cures80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

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

Interventions

Bone Marrow ConcentrateBIOLOGICAL

The intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Stem Cures

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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).

Time frame: Two Years

Secondary Outcomes

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).

Time frame: 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).

Time frame: Two Years

Visual Analog Scale (VAS) for leg pain

Time frame: 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)

Time frame: Two Years

PROMIS Mental Health

Data from ClinicalTrials.gov

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