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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 belowSelect...
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:Select...
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
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 moreAwards & 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.
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.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,408 Previous Clinical Trials
855,737 Total Patients Enrolled
Peter PassiasPrincipal InvestigatorNYU Langone Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a laminectomy at the surgery level.I am 18 years old or older.I had cancer but have been symptom-free for over 5 years after treatment.I have a missing or damaged part in my spine.The joints in my spine where the implant is are either missing or broken.I have a bone condition like Paget's disease or osteomalacia.I have tried non-surgical treatments for 6 weeks without improvement.I am not taking any medications that could affect bone or soft tissue healing.I have a recent fracture or damage in my spine where an implant is or will be placed.I have had a lumbar fusion surgery before.I am scheduled for a specific type of back surgery involving the middle and lower parts of my spine.
Research Study Groups:
This trial has the following groups:- Group 1: Bone Marrow Aspirate Concentrate (BMAC) + Allograft
- Group 2: Recombinant Human Bone Morphogenetic Protein-2 (BMP)
- Group 3: Autograft
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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