Trial | NCT04559295  Report issue

Title

Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs
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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
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 Started
Nov 21
2018
Primary Completion
Mar 19
2020
Study Completion
Apr 30
2021
Anticipated
Last Update
Sep 22
2020

Biological Bone Marrow Concentrate

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

  • Other names: Stem Cells

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

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
No Results Posted