BMAC + Allograft vs BMP-2 for Spinal Fusion

Overseen By Gregory Poorman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Chronic steroids

Disqualifiers: Prior lumbar fusion, BMI > 40, Metabolic bone disease, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1 day

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Peter Passias

Principal Investigator

NYU Langone Medical Center

Eligibility Criteria

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.

Inclusion Criteria

No contraindication to BMAC (as per manufacturer)

Signed consent form

I have tried non-surgical treatments for 6 weeks without improvement.

Exclusion Criteria

I need a laminectomy at the surgery level.

Unlikely to comply with the follow-up evaluation schedule

I had cancer but have been symptom-free for over 5 years after treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Operation

Participants undergo pre-operative assessments and preparation for lumbar spinal fusion surgery

1 week

1 visit (in-person)

Treatment

Participants receive lumbar spinal fusion surgery with either BMAC and allograft, BMP, or autograft

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Multiple visits at Week 6, Month 3, Month 6, Month 12, and Month 24

Treatment Details

Interventions

• Autograft
• BMAC
• BMAC + Allograft
• BMP-2

Trial Overview 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.

Participant Groups

Group I: Bone Marrow Aspirate Concentrate (BMAC) + Allograft Experimental Treatment 1 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 Control 1 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: Autograft Active Control 1 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.

Autograft is already approved in United States, European Union for the following indications:

Approved in United States as Autograft for:

• Lumbar fusion
• Spinal fusion
• Bone defects
• Fractures
• Delayed union
• Nonunion

Approved in European Union as Autograft for:

• Orthopedic trauma
• Bone reconstruction
• Spinal fusion
• Lumbar fusion

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+