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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares different methods to help bones fuse in spinal fusion surgery patients. Researchers are examining bone marrow concentrate mixed with donor bone (allograft), a protein called BMP-2, and the usual method using the patient's own bone (autograft). They aim to determine which option promotes better bone healing and improves quality of life. Individuals who have not undergone spinal fusion surgery before and have tried at least six weeks of other treatments without success may qualify for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance recovery and quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use drugs that might interfere with bone or soft tissue healing, like chronic systemic steroids.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Bone Marrow Aspirate Concentrate (BMAC) is safe for use in spine surgery. Studies have found that BMAC is usually well-tolerated, with few complications at the extraction site.

For Recombinant Human Bone Morphogenetic Protein-2 (BMP-2), research indicates it promotes bone growth. However, some patients have experienced side effects, such as swelling at the application site.

Specific safety information for using BMAC with allograft is not available, but BMAC alone is considered safe in spine surgeries. The FDA has approved BMP-2 for certain uses, suggesting it is generally safe. It is important to consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the BMAC + Allograft treatment for spinal fusion because it combines bone marrow aspirate concentrate (BMAC) with allograft bone chips, potentially enhancing bone healing and fusion. This method is unique because BMAC is rich in stem cells and growth factors, aiming to promote better bone regeneration compared to traditional options like autografts or BMP-2. Additionally, the use of the Harvest SmartPrep® system to concentrate BMAC may improve the efficiency and effectiveness of the treatment, offering an innovative approach to spinal fusion surgery.

What evidence suggests that this trial's treatments could be effective for spinal fusion?

Research has shown that both BMAC with allograft and BMP-2 are promising options for spinal fusion surgery. In this trial, participants will receive either BMAC with allograft or BMP-2. Studies have found that BMAC with allograft can be as effective as using the patient's own bone. This method is safe and may reduce treatment costs for patients with complex health conditions. Meanwhile, BMP-2, which aids bone growth, has also proven effective for spinal fusion. It has successfully fused bones and improved patient outcomes. Both treatments offer potential benefits for those needing spinal fusion surgery. ^{2 3 6 7 8}

Who Is on the Research Team?

Peter Passias

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

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

Pregnant or planning to become pregnant during the length of study participation

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8748018/

Bone Marrow Aspirate in Spine Surgery: Case Series and ... We reviewed the rationale, basic science, and clinical science for BMA usage in spine surgery and concluded that BMA is safe for use in spine surgery.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02924571?term=AREA%5BConditionSearch%5D((BRACHYDACTYLY,%20TYPE)%20OR%20(BMP2%20OR%20BMPR1B%20OR%20GDF5))&rank=4

Study Details | NCT02924571 | BMAC & Allograft vs BMP-2 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) ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1529943020303363

12. Health care costs and characteristics of spinal fusion ... Patients treated with BMAC were found to have a lower average cost of treating spine fusion patients with significant comorbidities (4 or 5+ CCI score) compared ...

4. researchgate.net researchgate.net/publication/260120225_Bone_Marrow_Concentrate_With_Allograft_Equivalent_to_Autograft_in_Lumbar_Fusions

Bone Marrow Concentrate With Allograft Equivalent to ... Objective: To compare autologous bone marrow concentrate mixed with allograft cancellous bone to iliac crest autograft in lumbar fusions.

5. insightbiosurg.com insightbiosurg.com/wp-content/uploads/2022/07/Hart-2014-BMAC-for-spinal-fusion-better-than-allograft-alone-RCT.pdf

Allograft alone versus allograft with bone marrow concentrate ... The aim of this study was to investigate the validity of. BMC addition to allografts in instrumented lumbar PLF surgery and confirm or refute the hypothesis ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11206007/

Effectiveness and Complications of Bone Marrow Aspirate ... This study aimed to identify the effectiveness and potential complications on the harvest site and knee of bone marrow aspirate concentrate ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2212628723003092

Bone Marrow Aspirate Concentrate Harvest Techniques for ... The purpose of this Technical Note is to review BMAC-harvesting techniques and 3 common BMAC harvest sites that should be familiar to and accessible to ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/71/NCT02924571/Prot_SAP_000.pdf

Prospective, Blinded, Non-randomized Study of ... Outcomes of Demineralized. Bone Matrix Enriched with Concentrated Bone Marrow Aspirate in Lumbar Fusion. International Journal of Spine.