Comparison of Posterior Cellular Bonegraft Options for Single Level Lumbar Spinal Fusion

NCT07187362 | Completed Phase 2 FDA Drug

• 1 other identifier: HE 15 10 002
• Study Type: interventional
• Target: 119
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study involves the assessment of alternatives to iliac bone graft during spinal fusion surgery. Four types of bone graft alternatives are being compared to iliac bone graft during the posterior portion of an anterior/posterior one-level lumbar spinal fusion. If you choose to participate in this study, you will be randomized (like a flip of a coin) to receive either your own iliac bone graft, bone morphogenetic protein (BMP, made from proteins found in the human body that stimulate bone growth), or one of the following stem-cell based bone graft alternatives for the posterior portion of your fusion surgery:

• Orthofix Trinity-made from donor bone and bone marrow stem cells
• Allosource Allostem-made from donor bone and fat stem cells
• Nutech Nucel-made from donor bone and placenta (after birth) stem cells Each bone graft alternatives has been approved by the United States Food and Drug Administration (FDA) and is commercially available with the exception that BMP application is considered "off-label". That is, BMP it is not approved for this indication, it is currently indicated for anterior fusion. The volume of bone graft that you will receive is the same for each graph type (approximately 5cc). Approximately 150 patients from the Midwest Spine and Brain Institute are expected to be enrolled in this study. If you choose to take part, your participation will last about 2+ year. At approximately 9 - 15 months after your surgery, you will be asked to return to the Midwest Spine and Brain Institute to undergo a limited CT scan of the fusion level to determine how you are healing. Your pain level and functional ability will also be evaluated at this visit.

Conditions

Disc Degenerative Disease; Spine Fusion for Degenerative Spine Disease

Keywords

surgery; allograft bone

Outcome Measures

Primary Outcomes (1)

• Solid spinal fusion

  Assessed by thin cut CT scan

  1 year

Secondary Outcomes (1)

• Pain and disability

  1, 2 and 2+ years

Study Arms (5)

iliac bone graft

ACTIVE COMPARATOR

old standard of care

Biological: Use iliac bone graft

Bone morphogenetic protein

EXPERIMENTAL

Known osteoinductive bone graph

Biological: use bone morphogenetic protein

MSCs from bone allograft

EXPERIMENTAL

extracted MSCs from human cadeveric bone

Biological: use bone derived allograft MSCs

MSCs from amnion/placental tissue

EXPERIMENTAL

MSCs derived from human afterbirth tissue

Biological: Use amnion/placental derived MSCs

MSCs from human adipose tissue

EXPERIMENTAL

MSCs derived from human fat

Biological: Use adipose tissue derived MSCs

Interventions

Use iliac bone graft BIOLOGICAL

iliac bone graft

use bone morphogenetic protein BIOLOGICAL

Bone morphogenetic protein

use bone derived allograft MSCs BIOLOGICAL

MSCs from bone allograft

Use adipose tissue derived MSCs BIOLOGICAL

MSCs from human adipose tissue

Use amnion/placental derived MSCs BIOLOGICAL

MSCs from amnion/placental tissue

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Midwest Spine & Brain Institute: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Glenn R BUTTERMANN

  Midwest Spine & Brain Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principle Investigator

Model Details: randomized, prospective

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 23, 2025
• Study Start: October 13, 2015
• Primary Completion: August 2, 2019
• Study Completion: January 31, 2020
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share