Clinical trial NCT04559295: Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Low Back Pain
Disc Disease
Disc Degeneration
Arthropathy Vertebrae
Sacral Disorder
Radiculopathy
Spinal Stenosis
Keywords: Stem cells
Bone marrow concentrate
Disc
Minimally invasive
Injections
Facet joint
Sacroiliac joint
Epidural space
Lead sponsor: Stem Cures
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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

Eligibility criteria: 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

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Two Years
Secondary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: Two Years
measure: Visual Analog Scale (VAS) for back pain
timeFrame: Two Years
measure: Visual Analog Scale (VAS) for leg pain
timeFrame: Two Years
measure: PROMIS Physical Health
timeFrame: Two Years
measure: PROMIS Mental Health
timeFrame: Two Years
measure: North American Spine Society (NASS) for patient satisfaction
timeFrame: Two Years
measure: EURO Quality of Life (EuroQol)
timeFrame: Two Years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Stem Cures
state: Ohio
Study officials:
affiliation: Stem Cures
name: Sairam Atluri, MD
role: PRINCIPAL_INVESTIGATOR
References: