What side effects are associated with this type of intervention?

The most common treatments for spinal fusion, including Bone Marrow Aspirate Concentrate (BMAC) and Allograft, and Recombinant Human Bone Morphogenetic Protein-2 (BMP-2), have specific side effects. BMAC and allograft treatments may lead to complications such as infection, pain at the donor site, and potential for graft rejection or failure. BMP-2, while promoting higher fusion rates, can cause inflammatory reactions, ectopic bone formation, and potential nerve-related issues. General side effects of spinal fusion surgeries include infection, blood loss, nerve damage, and prolonged recovery times.

What prior FDA approvals exist?

The FDA has approved several treatments for spinal fusion that align with the categories of Bone Marrow Aspirate Concentrate (BMAC) and Allograft, and Recombinant Human Bone Morphogenetic Protein-2 (BMP-2). BMP-2, marketed under the name INFUSE® Bone Graft, is an FDA-approved osteoinductive growth factor used to promote bone growth and fusion. It is commonly used in conjunction with a collagen sponge as a carrier. Additionally, various allograft materials, which may include demineralized bone matrix (DBM) and other scaffold supports, have been approved for use in spinal fusion procedures. These treatments aim to enhance the fusion process by providing a supportive matrix and promoting new bone formation.

What other types of research exist?

Promising novel alternatives for spinal fusion patients include: 1) Natural Bone Collagen Scaffold (NBCS) combined with autologous enriched bone marrow cells, which has shown to support population expansion and differentiation of bone marrow cells in an ovine model. 2) Fully implantable motorized intramedullary nails for limb lengthening and bone transport, which offer a new approach to bone regeneration and stabilization. These alternatives provide innovative methods for enhancing bone growth and stability in spinal fusion procedures.

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Bone Graft

BMAC + Allograft vs BMP-2 for Spinal Fusion

N/A

Waitlist Available

Led By Peter Passias

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Currently requires laminectomy at level of surgery

Incompetent or missing anterior arch at the affected level (e.g. laminectomy, pars defect)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, year 2

Awards & highlights

No Placebo-Only Group

Summary

This trial tests three methods to help bones in the lower back heal after surgery. It compares a mix of bone marrow and donated tissue, a lab-made protein, and the standard method using the patient's own bone. The goal is to find which method works best for patients with spinal issues.

Who is the study for?

This trial is for adults over 18 needing elective spinal fusion surgery, who have tried non-surgical treatments for at least 6 weeks. Candidates should not be pregnant, have a BMI over 40, or suffer from certain bone diseases or allergies to titanium. Prior lumbar surgeries may disqualify them.

What is being tested?

The study compares three methods of spinal fusion: using the patient's own bone graft (autograft), combining bone marrow concentrate (BMAC) with allograft (donor tissue), and using recombinant human BMP-2. It aims to determine which method is safest and most effective in improving quality of life.

What are the potential side effects?

Potential side effects could include pain at the graft site, infection, inflammation around the spine, allergic reactions to materials used in surgery like BMP-2 or titanium if applicable, and complications related to non-healing of bones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a specific type of back surgery involving the middle and lower parts of my spine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need a laminectomy at the surgery level.

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I have a missing or damaged part in my spine.

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The joints in my spine where the implant is are either missing or broken.

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I have a bone condition like Paget's disease or osteomalacia.

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I have a recent fracture or damage in my spine where an implant is or will be placed.

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I have had a lumbar fusion surgery before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, year 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Blood Levels during Intraoperative Period

Change in Blood Levels during Perioperative Period

Change in Euro-Qol 5-Dimension (EQ-5D) Scores from Baseline

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Bone Marrow Aspirate Concentrate (BMAC) + AllograftExperimental Treatment1 Intervention

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 II: Recombinant Human Bone Morphogenetic Protein-2 (BMP)Active Control1 Intervention

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 III: AutograftActive Control1 Intervention

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bone Marrow Aspirate Concentrate (BMAC) and allograft work by using stem cells and scaffold support to enhance bone healing and fusion. The stem cells in BMAC can differentiate into bone-forming cells, while the allograft provides a structure for new bone growth. Recombinant Human Bone Morphogenetic Protein-2 (BMP-2) is an osteoinductive growth factor that promotes the differentiation of mesenchymal stem cells into osteoblasts, which are critical for bone formation. These mechanisms are important for spinal fusion patients as they improve the fusion process, leading to better stability, pain relief, and overall quality of life.