Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04559295
• Other study ID #: Regen_003-1018
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: November 21, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2020
• Source: Stem Cures
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 30, 2021
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy Vertebrae
• Back Pain
• Disc Degeneration
• Disc Disease
• Intervertebral Disc Degeneration
• Joint Diseases
• Low Back Pain
• Radiculopathy
• Sacral Disorder
• Spinal Stenosis

Intervention

Biological:
• Bone Marrow Concentrate
The intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints

Locations

Country	Name	City	State
United States	Stem Cures	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Stem Cures

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Two Years
Secondary	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).	Two Years
Secondary	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).	Two Years
Secondary	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).	Two Years
Secondary	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)	Two Years
Secondary	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).	Two Years
Secondary	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).	Two Years
Secondary	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).	Two Years