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

NCT03912454 | Unknown

• 1 other identifier: BMAC1601
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Degenerative Disc Disease; Spine Degeneration

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• BMAC injection survival

  12 months post-injection

• MRI evaluation of the degenerative disc

  1 day (Pre-injection) and 12 months post-injection

• CFU-F Analysis

  1 Day of Injection

Study Arms (1)

BMAC Injection

EXPERIMENTAL

Other: Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection

Interventions

Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection OTHER

Subjects will undergo bone marrow aspiration from the iliac crest. Bone marrow will be concentrated and injected into the symptomatic lumbar disc.

BMAC Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Bone and Joint Clinic of Baton Rouge: lead

Study Sites (1)

Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Injections

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 11, 2019
• Study Start: April 8, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

US (1)