NCT04559295

Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs

Study of Bone of Marrow Concentrate (BMC) Injection in Discs, Facets, Sacroiliac Joints, and Epidural Space for Chronic Lower Back Pain With and Without Radiculopathy

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Stem Cures · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Intradiscal delivery of bone marrow concentrate (BMC) into discs, facet, epidural space, and sacroiliac joints

Detailed description

To study if the outcomes for the injection of bone marrow concentrate (BMC) in patients with disc, facet, epidural space, and sacroiliac joint pain create a clinically meaningful improvement in pain and function. Further analysis will determine if there be any variance in patient reported outcome due to the individual's pre-procedure cell count and analysis. Hypothesis 1: An injection of autologous BMC into discs, facets, sacroiliac joints, and epidural space will improve pain and function in patients with IDD Hypothesis 2: There will be a direct relationship between an individual's BMC composition and the patient's reported outcomes

Conditions

• Low Back Pain
• Disc Disease
• Disc Degeneration
• Arthropathy Vertebrae
• Sacral Disorder
• Radiculopathy
• Spinal Stenosis

Interventions

Type	Name	Description
BIOLOGICAL	Bone Marrow Concentrate	The intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints

Timeline

• Start date: 2018-11-21
• Primary completion: 2020-03-19
• Completion: 2021-04-30
• First posted: 2020-09-22
• Last updated: 2020-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study