A Prospective Study of Clinical Outcomes Following a Single Intradiscal Injection of Bone Marrow Aspirate Concentrate (BMAC) for Single Level Discogenic Low Back Pain

This single-institution prospective case series (single arm) study will assess the clinical outcomes of patients diagnosed with 1 or 2 level level discogenic low back pain following an intradiscal injection of bone marrow aspirate concentrate (BMAC).

Study Overview

• Status: Active, not recruiting
• Conditions: Degenerative Disc Disease; Spine Degeneration
• Intervention / Treatment: Other: Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection

Detailed Description

Background:

BMAC is a cellular rich fraction of bone marrow aspirate that can be readily prepared at the point of care without additional processing steps to manipulate or isolate cells. In addition, BMAC contains growth factors from the peripheral blood which may promote disc healing.

Study Summary:

The study population will consist of up to 20 patients aged 18- 60 with unresolved low back pain attributable to intervertebral disc degeneration. Clinical exam will indicate the intervertebral disc as the source of pain with features such as midline pain, pain upon rising from a seated position, or positive responses to centralization maneuvers. Moderate single level lumbar disc (L1-S1) degeneration (<50% disc height) will be confirmed on MRI. Other low back pain generators must be eliminated prior to study enrollment. Subjects must meet minimum score criteria on baseline PROs (VAS>=40 and ODI>=30). Subjects that meet all of the inclusion and none of the exclusion criteria will be invited to participate in the study.

Enrolled subjects will undergo bone marrow aspiration and intradiscal injection by an experienced orthopedic spine surgeon. Subjects will be followed for 1 year to evaluate the effects of the disc injection.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Bone and Joint Clinic of Baton Rouge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages 18 to 60 years
• Symptomatic discogenic low back pain, clinically demonstrated by a loss of lumbar range of motion and pain to deep palpation over the symptomatic disc.
• MRI confirmed single level lumbar disc height loss <50% (Modified Pfirrman grade <=7).

• MRI confirmed isolated lumbar disc degeneration OR

  o If zygapophysial joint degeneration is present on MRI, subject must have failed intra-articular injection or medial branch block (<50% pain relief) to be eligible for enrollment. PI will have final discretion as to whether the patient's symptoms originate from a single disc.

• Patient must have completed at least 3 months conservative treatment. Conservative treatment may include NSAIDs or Acetaminophen when medically appropriate and physiotherapy, chiropractic care, or a guided home exercise program.
• BMI < 40
• Back pain greater than leg pain with back pain rating on a 100 mm visual analog scale (VAS) >= 40 mm
• Pain Catastrophizing Scale <= 30

Exclusion Criteria:

• Prior fusion at the level to be treated
• >2 levels requiring intervention
• Non discogenic source of back pain
• Intradural disc herniation
• Full thickness annular tear at the index level.
• Lumbar spine surgery within the past 6 months.
• Pregnant or breastfeeding.
• Known allergy or sensitivity to heparin or citrate (used for processing BMAC)
• Coagulopathy preventing spinal injection
• Active infection
• Malignancy within past 5 years other than basal cell or squamous cell skin cancer.
• Severe uncontrolled medical condition
• Other significant pain generator that may affect the subject's answers to PRO questionnaires.
• Current Tobacco use
• Pending litigation involving subject's back pain
• Incarcerated at the time of study enrollment
• Inability to give informed consent for study participation for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMAC Injection	Other: Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection; Subjects will undergo bone marrow aspiration from the iliac crest. Bone marrow will be concentrated and injected into the symptomatic lumbar disc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale (VAS) Pain Score	The severity of back and leg pain will be evaluated using a 100 mm visual analog scale (VAS) where a higher number indicates greater pain.	1 day (Pre-injection) to 12 months post-injection
Change in Oswestry Disability Index	The Oswestry Disability Index (ODI) is the most commonly used patient reported outcome measure in patients with low back pain. The ODI score ranges from 0% to 100%. A higher score corresponds to a greater disability.	1 day (Pre-injection) to 12 months post-injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMAC injection survival	The number of subjects who do not proceed to surgery for their discogenic back pain and answer YES to " Are you satisfied with the outcome of this injection? OR NO to "Are you seeking any additional treatments for your discogenic back pain at this time?"	12 months post-injection
MRI evaluation of the degenerative disc	A modified Pfirrman grade will be assigned and used to assess changes in the disc pre-injection to 1 year post - injection	1 day (Pre-injection) and 12 months post-injection
CFU-F Analysis	Cell viability testing and CFU-F assay will be conducted on an aliquot from each subject's BMAC. Number of CFU-F from each patient will be used to correlate with patient reported outcomes.	1 Day of Injection

Collaborators and Investigators

• Sponsor: Bone and Joint Clinic of Baton Rouge

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Intervertebral Disc Degeneration
• Other Study ID Numbers: BMAC1601

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No