Spinal Fusion Graft Techniques for Degenerative Disc Disease

(BMAC Trial)

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Chronic steroids

Disqualifiers: Spondylolisthesis, Metabolic bone disease, others

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

Compensation: Varies

Number of Visits: 6

Duration: Surgery and immediate recovery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods to help people with degenerative disc disease, a condition that causes back pain due to worn-out discs in the spine. Researchers compare bone marrow aspirate concentrate (BMAC) with allograft to traditional iliac crest bone grafts (ICBG) for spinal fusion surgery. The goal is to determine which method better aids in spinal fusion, potentially reducing pain and improving mobility. Candidates for this study include those who have tried other treatments for at least six weeks without success and are scheduled for spinal fusion surgery.

As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could enhance quality of life.

Do I need to stop my current medications for the trial?

The trial excludes people using medications that interfere with bone healing, like chronic steroids, so you may need to stop those. The protocol doesn't specify about other medications.

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

Previous studies have shown that bone marrow aspirate concentrate (BMAC) is safe for use in spine surgery. Researchers have found that BMAC does not cause serious side effects in patients. However, the low number of stem cells collected from bone marrow might affect the results.

For iliac crest bone grafts (ICBG), studies indicate they are generally safe in lower back surgeries. Some patients may experience a slight increase in blood loss during the operation, but this is usually not significant. Overall, ICBG is considered a safe option for spinal fusion surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the spinal fusion graft techniques for degenerative disc disease because they explore innovative ways to improve spinal fusion outcomes. The BMAC & Allograft technique is unique as it uses bone marrow aspirate concentrate (BMAC) combined with allograft bone chips, potentially enhancing bone healing and fusion due to the regenerative properties of BMAC. This method offers a less invasive alternative to the standard iliac crest bone graft (ICBG), which involves harvesting bone directly from the hip and can be more painful and risky. Both methods aim to stabilize the spine, but the use of BMAC could lead to faster recovery and improved fusion rates, sparking interest in its potential benefits over traditional options.

What evidence suggests that this trial's treatments could be effective for degenerative disc disease?

This trial will compare two spinal fusion graft techniques for degenerative disc disease. Research has shown that using bone marrow aspirate concentrate (BMAC) with donor bone (allograft), which participants in one arm of this trial may receive, can be effective in spinal fusion surgeries. One study found that patients who received BMAC and allograft generally experienced successful spinal fusion, with good bone healing and improved function. Another study indicated that BMAC with allograft might be as effective, or even more so, than traditional bone grafts taken from the hip (iliac crest bone grafts), offering similar success rates in fusion.

Participants in another arm of this trial will receive bone grafts from the hip (ICBG), which have been used successfully in spinal fusion surgeries for a long time. Research consistently shows that ICBG can effectively help bones in the spine fuse together, leading to better stability and less pain. However, ICBG may cause more discomfort because it involves taking bone from the hip. Both treatments have shown promise, but each has its own benefits and considerations. ^{1 3 6 7 8}

Who Is on the Research Team?

Peter Passias, MD

Principal Investigator

NYU School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need elective posterior spinal fusion for thoracolumbar or lumbar spine issues and have not improved after 6 weeks of non-surgical care. They must be able to follow post-op plans, not be pregnant, nor involved in other device trials recently, and free from certain bone diseases or chemical dependencies.

Inclusion Criteria

My back pain affects my daily life significantly.

I am scheduled for a specific back surgery involving the middle to lower spine.

No contraindication to BMAC (as per manufacturer)

Exclusion Criteria

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

I am not taking medications like chronic steroids that affect bone healing.

I currently have cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo posterior lumbar/lumbosacral spinal fusion with either BMAC + allograft or ICBG

Surgery and immediate recovery

Follow-up

Participants are monitored for fusion rate and health-related quality of life parameters

2 years

Visits at 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively

What Are the Treatments Tested in This Trial?

Interventions

• BMAC & Allograft
• Iliac Crest Bone Graft

Trial Overview The study compares the effectiveness of two types of spinal fusion grafts: one using a combination of bone marrow aspirate concentrate (BMAC) with allograft versus the traditional iliac crest bone graft (ICBG). It's a randomized clinical trial at a single center.

How Is the Trial Designed?

Group I: BMAC & Allograft Active Control 1 Intervention

Subjects will be treated with bone marrow aspirate concentrate (BMAC) and allograft during posterior lumbar/lumbosacral spinal fusion. During lumbar spine surgery, 12 teaspoons of bone marrow will be taken (aspirated) from one side of hip bone. This may be repeated on the other side of hip bone for a total of 12, 24, or 36 teaspoons of bone marrow total taken from your hip bone depending on the decision made by the surgeon. The bone marrow will then be concentrated with a machine for 15 minutes to a final volume of 2, 4, or 6 teaspoons of BMAC. BMAC will be combined with packed allograft bone chips using another machine to produce two or three constructed bone logs. The bone logs will be laid along the backside of the spine and between each vertebral body.

Group II: Iliac Crest Bone Graft Active Control 1 Intervention

Subjects who are in the Iliac Crest Bone Graft arm will be treated with Iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion. During lumbar spine surgery, the surgeon will make an incision to expose the iliac crest (hip bone), and cutting out the segments of the bone that will be needed, based on the decision of the surgeon. The bone chips will be laid along the backside of the spine and also between each vertebral body where the bone will fuse into place. When the bone becomes solid/fused, there is no movement in the fused spine.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT01746212

Outcomes of Degenerative Disc Disease Patients Treated ... The purpose of this study is to report the radiographic, clinical, and functional outcomes of a consecutive series of patients diagnosed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8092934/

Stem Cells and Spinal Fusion - PMC Bone marrow aspirate concentrate (BMAC) + allograft compared with iliac crest bone graft during posterior lumbar/lumbosacral spine fusion. Prospective, RCT ...

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

Prospective, Blinded, Non-randomized Study of ... Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate and Allograft. Versus Recombinant Bone Morphogenetic Protein-2 (BMP). NCT Number ...

4. withpower.com withpower.com/trial/phase-intervertebral-disc-degeneration-7-2012-f5478

Spinal Fusion Graft Techniques for Degenerative Disc ... Trial Overview The study compares the effectiveness of two types of spinal fusion grafts: one using a combination of bone marrow aspirate concentrate (BMAC) ...

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 instrumented PLF is a commonly accepted surgical procedure and overall the most common technique performed to obtain fusion in the lumbar spine [8]. It pro-.

6. 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.

7. ijssurgery.com ijssurgery.com/content/early/2023/11/30/8560/mailto%20%3A%20safdar.khan%40osumc.edu

Osteobiologics and Value-Based Care: Challenges ... Animal studies have shown success with autologous stem cells and BMAC, but the yield of mesenchymal stem cells from bone marrow is low,49 and ...

8. journals.lww.com journals.lww.com/jbjsjournal/fulltext/2021/04210/bone_marrow_aspirate_concentrate_combined_with_in.9.aspx

Bone Marrow Aspirate Concentrate Combined with in Situ... The main purpose of this study was to investigate the repair efficacy of BMAC-UPAL gel for the treatment of IVD defects after discectomy in rabbits.