Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs

Status unconfirmed · Phase 2/Phase 3

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

In brief

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

Key facts

Study ID

NCT04559295

Run by

Stem Cures

People needed

80

Starts

2018-11-21

Expected to finish

2021-04-30

Last updated by the study team

2020-09-22

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stem Cures — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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