Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs

Stem Cures

Status and phase: Unknown; Phase 3; Phase 2

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

Treatments: Biological: Bone Marrow Concentrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04559295

Regen_003-1018

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Stem Cells (BMC)

Experimental group

Description:

Subjects in the BMC arm received an injection of bone marrow concentrate

Treatment:

Biological: Bone Marrow Concentrate

Control

No Intervention group

Description:

Subjects in the control arm received no treatment for their condition