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

Status unconfirmed · Not applicable

Conditions studied: Degenerative Disc Disease, Spine Degeneration

In brief

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).

Key facts

Study ID

NCT03912454

Run by

Bone and Joint Clinic of Baton Rouge

People needed

20

Starts

2019-04-08

Expected to finish

2022-09-01

Last updated by the study team

2022-03-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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