Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs
Primary Purpose
Low Back Pain, Disc Disease, Disc Degeneration
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bone Marrow Concentrate
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Stem cells, Bone marrow concentrate, Disc, Minimally invasive, Injections, Facet joint, Sacroiliac joint, Epidural space
Eligibility Criteria
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
Sites / Locations
- Stem Cures
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Stem Cells (BMC)
Control
Arm Description
Subjects in the BMC arm received an injection of bone marrow concentrate
Subjects in the control arm received no treatment for their condition
Outcomes
Primary Outcome Measures
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst).
Secondary Outcome Measures
Numeric Rating Scale (NRS)
The NRS consists of a numeric version of the visual analog scale. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. Scale for NRS is from 0 (best) - 10 (worst).
Visual Analog Scale (VAS) for back pain
When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for back pain is from 0 (best) - 10 (worst).
Visual Analog Scale (VAS) for leg pain
When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for leg pain is from 0 (best) - 10 (worst).
PROMIS Physical Health
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Physical Health is from 16.2 (worst) - 67.7 (best)
PROMIS Mental Health
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Mental Health is from 21.2 (worst) - 67.6 (best).
North American Spine Society (NASS) for patient satisfaction
The North American Spine Society (NASS) developed an outcome assessment instrument to measure diverse dimensions of the impact of lumbar spine problems. Scale range is from 1 to 4 (best to worst).
EURO Quality of Life (EuroQol)
EuroQol is an instrument which evaluates the generic quality of life developed in Europe and widely used. Scale is from 0.33 (worst - 0.88 (best).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04559295
Brief Title
Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs
Official Title
Study of Bone of Marrow Concentrate (BMC) Injection in Discs, Facets, Sacroiliac Joints, and Epidural Space for Chronic Lower Back Pain With and Without Radiculopathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 21, 2018 (Actual)
Primary Completion Date
March 19, 2020 (Actual)
Study Completion Date
April 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stem Cures
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Intradiscal delivery of bone marrow concentrate (BMC) into discs, facet, epidural space, and sacroiliac joints
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Disc Disease, Disc Degeneration, Arthropathy Vertebrae, Sacral Disorder, Radiculopathy, Spinal Stenosis
Keywords
Stem cells, Bone marrow concentrate, Disc, Minimally invasive, Injections, Facet joint, Sacroiliac joint, Epidural space
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A prospective evaluation of a cohort of patients with a specific characteristic over time to see if they develop a particular endpoint or outcome based on a stated hypothesis.
Masking
Outcomes Assessor
Masking Description
Independent Observer was blinded as to wether a subject received treatment or was in the control group.
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stem Cells (BMC)
Arm Type
Experimental
Arm Description
Subjects in the BMC arm received an injection of bone marrow concentrate
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects in the control arm received no treatment for their condition
Intervention Type
Biological
Intervention Name(s)
Bone Marrow Concentrate
Other Intervention Name(s)
Stem Cells
Intervention Description
The intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints
Primary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst).
Time Frame
Two Years
Secondary Outcome Measure Information:
Title
Numeric Rating Scale (NRS)
Description
The NRS consists of a numeric version of the visual analog scale. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. Scale for NRS is from 0 (best) - 10 (worst).
Time Frame
Two Years
Title
Visual Analog Scale (VAS) for back pain
Description
When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for back pain is from 0 (best) - 10 (worst).
Time Frame
Two Years
Title
Visual Analog Scale (VAS) for leg pain
Description
When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for leg pain is from 0 (best) - 10 (worst).
Time Frame
Two Years
Title
PROMIS Physical Health
Description
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Physical Health is from 16.2 (worst) - 67.7 (best)
Time Frame
Two Years
Title
PROMIS Mental Health
Description
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Mental Health is from 21.2 (worst) - 67.6 (best).
Time Frame
Two Years
Title
North American Spine Society (NASS) for patient satisfaction
Description
The North American Spine Society (NASS) developed an outcome assessment instrument to measure diverse dimensions of the impact of lumbar spine problems. Scale range is from 1 to 4 (best to worst).
Time Frame
Two Years
Title
EURO Quality of Life (EuroQol)
Description
EuroQol is an instrument which evaluates the generic quality of life developed in Europe and widely used. Scale is from 0.33 (worst - 0.88 (best).
Time Frame
Two Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sairam Atluri, MD
Organizational Affiliation
Stem Cures
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stem Cures
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45230
Country
United States
12. IPD Sharing Statement
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Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs
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