Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs

Phase 2

• Conditions: Sacral Disorder; Low Back Pain; Disc Disease; Disc Degeneration; Radiculopathy; Spinal Stenosis; Arthropathy Vertebrae

• Registration Number: NCT04559295
• Lead Sponsor: Stem Cures

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

Study Timeline

• Study Start: 2018-11-21
• Primary Completion: 2020-03-19
• Study First Submitted: 2020-08-31
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-21
• Last Update Submitted: 2020-09-21
• Study First Posted: 2020-09-22
• Last Update Posted: 2020-09-22
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	Two Years	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

Name	Time	Method
Numeric Rating Scale (NRS)	Two Years	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	Two Years	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	Two Years	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).
EURO Quality of Life (EuroQol)	Two Years	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).
North American Spine Society (NASS) for patient satisfaction	Two Years	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).
PROMIS Physical Health	Two Years	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	Two Years	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).

Trial Locations

Locations (1)

Stem Cures; 🇺🇸 Cincinnati, Ohio, United States