Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs

Last updated: September 21, 2020
Sponsor: Stem Cures
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Chronic Pain

Spondylolisthesis

Radiculopathy

Treatment

N/A

Clinical Study ID

NCT04559295
Regen_003-1018
  • Ages 18-60
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A high index of suspicion for discogenic pain, i.e. painful degenerative discs with orwithout 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, epiduralsteroid 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 detectedon T2 or STIR MRI

  • No evidence of contraindications to undergo procedure such as pregnancy, activeinfection, bleeding disorder, or metastatic cancer

  • English speaking

Exclusion

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

Study Design

Total Participants: 80
Study Start date:
November 21, 2018
Estimated Completion Date:
April 30, 2021

Study 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

Connect with a study center

  • Stem Cures

    Cincinnati, Ohio 45230
    United States

    Site Not Available

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