NCT03912454

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Bone and Joint Clinic of Baton Rouge · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Degenerative Disc Disease
• Spine Degeneration

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-08
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2019-04-11
• Last updated: 2022-03-16

Locations

1 site across 1 country: United States