NCT07187362

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

Completed Phase 2, PHASE3 Last updated 8 October 2025

What this trial tests

Phase 2, PHASE3 trial testing Use iliac bone graft in Disc Degenerative Disease in 119 participants. Completed in 31 January 2020.

Timeline

13 October 2015

Primary endpoint
2 August 2019

31 January 2020

Quick facts

Lead sponsor	Midwest Spine & Brain Institute
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	119
Start date	13 October 2015
Primary completion	2 August 2019
Estimated completion	31 January 2020

Drugs / interventions tested

• Use iliac bone graft — full drug profile →
• use bone morphogenetic protein — full drug profile →
• use bone derived allograft MSCs — full drug profile →
• Use adipose tissue derived MSCs — full drug profile →
• Use amnion/placental derived MSCs — full drug profile →

Conditions studied

• Disc Degenerative Disease — all drugs for Disc Degenerative Disease →
• Spine Fusion for Degenerative Spine Disease — all drugs for Spine Fusion for Degenerative Spine Disease →

Sponsor

Midwest Spine & Brain Institute

Who can join

Adults 18 to 65, any sex, with Disc Degenerative Disease or Spine Fusion for Degenerative Spine Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.