BMAC & Allograft vs BMP-2

NCT ID: NCT02924571

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-24
• Study Completion Date: 2024-06-03

Brief 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.

Detailed Description

This study will be a prospective, randomized clinical study at a single-center, NYU Langone Medical Center. It is intended to compare and evaluate the efficacy of subjects who are either treated with (1) bone marrow aspirate concentrate (BMAC) and allograft or (2) recombinant human bone morphogenetic protein-2 (BMP) or (3) autograft (control) during lumbar spinal fusion with interbody support. The clinical, radiographic, and Health Related Quality of Life (HRQOL) outcomes will be assessed in operatively treated adult spinal degenerative disease patients undergoing lumbar spinal fusion.

Conditions

Spinal Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bone Marrow Aspirate Concentrate (BMAC) + Allograft

A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite.

If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1):

• 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft)
• 2-level fusion: 20 cc of BMAC from 120 cc of BMA
• 3-level fusion: 20 cc of BMAC from 120 cc of BMA
• 4-level fusion: 180 cc kit
• 5-level fusion: 240 cc kit

If not using Harvest Graft Delivery Kit:

• Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls).

Group Type: EXPERIMENTAL

Bone Marrow Aspirate Concentrate (BMAC) + Allograft

Intervention Type: DEVICE

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.

Recombinant Human Bone Morphogenetic Protein-2 (BMP)

12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions.

The BMP kit use per level is as follows:

• 1 Level Fusion: Extra small kit (1.4 cc)
• 2 Level Fusion: Small Kit (2.8cc)
• 3 Level Fusion: (4.2 cc)
• 4 Level Fusion: Medium Kit (5.6cc)
• 5 Level Fusion: (7.0 cc)

Group Type: ACTIVE_COMPARATOR

Recombinant Human Bone Morphogenetic Protein-2 (BMP)

Intervention Type: DEVICE

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.

Autograft

As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion.

Group Type: ACTIVE_COMPARATOR

Autograft

Intervention Type: PROCEDURE

Autograft with bone marrow aspirate.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Autograft

Autograft with bone marrow aspirate.

Intervention Type: PROCEDURE

Other Intervention Names

Harvest BMAC System; INFUSE rhBMP-2

Eligibility Criteria

Inclusion Criteria

• Must be 18 years old or older
• Scheduled for elective posterior or anterior and posterior spinal fusion of the thoracolumbar spine with or without anterior interbody support
• Failed at least 6 weeks of conservative care
• No contraindication to BMAC (as per manufacturer)
• Signed consent form

Exclusion Criteria

• Prior lumbar fusion surgery at operative level (prior discectomy and/or laminectomy allowed)
• Incompetent or missing anterior arch at the affected level (e.g. laminectomy, pars defect)
• Currently requires laminectomy at level of surgery
• Facet joints at implant level are absent or fractured
• Post-traumatic vertebral body compromise or acute fracture at implant level
• Body mass Index (BMI) > 40
• Known allergy to titanium
• Paget's disease, osteomalacia, or any other metabolic bone disease
• Use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids)
• Unlikely to comply with the follow-up evaluation schedule
• Active malignancy defined as history of invasive malignancy, except if the subject has received treatment and displayed no clinical signs and symptoms for at least five years
• Pregnant or planning to become pregnant during the length of study participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Passias

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-01160

Identifier Type: -

Identifier Source: org_study_id