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BMAC & Allograft vs BMP-2

NCT02924571 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-07-08

Study results available
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Summary

The aim of this investigation is to compare the use of bone marrow aspirate concentrate (BMAC) and allograft versus recombinant human bone morphogenetic protein-2 (BMP) versus the gold standard fusion in subjects undergoing elective lumbar spinal fusion with interbody support. The safety and efficacy of the surgical interventions will be evaluated by assessing fusion status and subjects' quality of life outcomes.

Conditions

  • Spinal Fusion

Interventions

DEVICE

Bone Marrow Aspirate Concentrate (BMAC) + Allograft

Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.

DEVICE

Recombinant Human Bone Morphogenetic Protein-2 (BMP)

INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.

PROCEDURE

Autograft

Autograft with bone marrow aspirate.

Sponsors & Collaborators

Principal Investigators

  • Peter Passias · NYU Langone Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2024-06-03
Completion
2024-06-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02924571 on ClinicalTrials.gov