Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs
NCT ID: NCT04559295
Last Updated: 2020-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2018-11-21
2021-04-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Stem Cells (BMC)
Subjects in the BMC arm received an injection of bone marrow concentrate
Bone Marrow Concentrate
The intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints
Control
Subjects in the control arm received no treatment for their condition
No interventions assigned to this group
Interventions
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Bone Marrow Concentrate
The intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Stem Cures
OTHER
Responsible Party
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Principal Investigators
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Sairam Atluri, MD
Role: PRINCIPAL_INVESTIGATOR
Stem Cures
Locations
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Stem Cures
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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Regen_003-1018
Identifier Type: -
Identifier Source: org_study_id
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