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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03912454
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bone and Joint Clinic of Baton Rouge
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Degenerative Disc Disease, Spine Degeneration
Additional Details

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.

Arms & Interventions

Arms

Experimental: BMAC Injection

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bone and Joint Clinic of Baton Rouge, Baton Rouge, Louisiana

Status

Address

Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, 70808