Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs

September 21, 2020 updated by: Stem Cures

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45230
        • Stem Cures

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stem Cells (BMC)
Subjects in the BMC arm received an injection of bone marrow concentrate
Biological: Bone Marrow Concentrate
The intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints
Other Names:
  • Stem Cells
NO_INTERVENTION: Control
Subjects in the control arm received no treatment for their condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: 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).
Two Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS)
Time Frame: 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).
Two Years
Visual Analog Scale (VAS) for back pain
Time Frame: 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).
Two Years
PROMIS Physical Health
Time Frame: 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)
Two Years
PROMIS Mental Health
Time Frame: 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).
Two Years
North American Spine Society (NASS) for patient satisfaction
Time Frame: 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).
Two Years
EURO Quality of Life (EuroQol)
Time Frame: 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).
Two Years
Visual Analog Scale (VAS) for leg pain
Time Frame: 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).
Two Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stem Cures

Investigators

  • Principal Investigator: Sairam Atluri, MD, Stem Cures

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 21, 2018

Primary Completion (ACTUAL)

March 19, 2020

Study Completion (ANTICIPATED)

April 30, 2021

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (ACTUAL)

September 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Regen_003-1018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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