Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs (NCT04559295) | Clinical Trial Compass
UnknownPhase 2/3
Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs
United States80 participantsStarted 2018-11-21
Plain-language summary
Intradiscal delivery of bone marrow concentrate (BMC) into discs, facet, epidural space, and sacroiliac joints
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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