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

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ClinicalTrials.gov Identifier: NCT03912454
Recruitment Status : Enrolling by invitation
First Posted : April 11, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Bone and Joint Clinic of Baton Rouge

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

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spine Degeneration Other: Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection Not Applicable

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 single level 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of Clinical Outcomes Following a Single Intradiscal Injection of Bone Marrow Aspirate Concentrate (BMAC) for Single Level Discogenic Low Back Pain
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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.




Primary Outcome Measures :
  1. Change in Visual Analog Scale (VAS) Pain Score [ Time Frame: 1 day (Pre-injection) to 12 months post-injection ]
    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.

  2. Change in Oswestry Disability Index [ Time Frame: 1 day (Pre-injection) to 12 months post-injection ]
    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.


Secondary Outcome Measures :
  1. BMAC injection survival [ Time Frame: 12 months post-injection ]
    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?"

  2. MRI evaluation of the degenerative disc [ Time Frame: 1 day (Pre-injection) and 12 months post-injection ]
    A modified Pfirrman grade will be assigned and used to assess changes in the disc pre-injection to 1 year post - injection

  3. CFU-F Analysis [ Time Frame: 1 Day of Injection ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • >1 level 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912454


Locations
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United States, Louisiana
Bone and Joint Clinic of Baton Rouge
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Bone and Joint Clinic of Baton Rouge

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Responsible Party: Bone and Joint Clinic of Baton Rouge
ClinicalTrials.gov Identifier: NCT03912454     History of Changes
Other Study ID Numbers: BMAC1601
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases