Bone Marrow Aspirate Concentrate (BMAC) for Fusion of Spine (Disease)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
New York University School of Medicine, New York, NY
Fusion of Spine (Disease)
Bone Marrow Aspirate Concentrate (BMAC) - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a specific type of bone graft may help improve the quality of life for individuals who have had spinal surgery.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Bone Marrow Aspirate Concentrate (BMAC) will improve 3 primary outcomes in patients with Fusion of Spine (Disease). Measurement will happen over the course of Baseline to 2 Years.

Baseline to 2 Years
Numeric Pain Rating Scale (NRS)
Oswestry Disability Index (ODI)
SF-12 (Short Form Health Survey)

Trial Safety

Trial Design

2 Treatment Groups

Recombinant Human Bone Morphogenetic Protein-2 (BMP)
1 of 2
Bone Marrow Aspirate Concentrate (BMAC)
1 of 2
Active Control
Experimental Treatment

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Bone Marrow Aspirate Concentrate (BMAC) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Bone Marrow Aspirate Concentrate (BMAC)
Procedure
Recombinant Human Bone Morphogenetic Protein-2 (BMP)
Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 2 years for reporting.

Closest Location

New York University School of Medicine - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
device placement The person is scheduled to have a spinal fusion surgery, either for the back of the thoracic spine or for the back of the lumbar spine, with or without a device to support the spine in the front. show original
You must be eighteen years old or older in order to use this service. show original
Signed consent form
They have tried at least 6 weeks of conservative care, which has failed. show original
There is no reason you can't use BMAC, according to the manufacturer. show original

Patient Q&A Section

What is fusion of spine (disease)?

"The most commonly reported back symptoms include pain, stiffness and swelling in one or more joints. Chronic low back symptoms are strongly associated with disability and are usually attributed to spinal osteophytes or disc herniations." - Anonymous Online Contributor

Unverified Answer

What causes fusion of spine (disease)?

"Spinal fusion can be caused by many factors including trauma (from a fall or a motor vehicle accident), bone pain or instability, spinal malformation, or spinal metastases. In these cases, spinal fusion may be the only treatment option." - Anonymous Online Contributor

Unverified Answer

Can fusion of spine (disease) be cured?

"Data from a recent study of this study indicate that the current concepts of spinal fusion may not be sufficient to prevent the disease progression. The application of an algorithm to detect fusion of spine by fluoroscopy in pre-operation phase is effective in prevention of further disease progression." - Anonymous Online Contributor

Unverified Answer

What are the signs of fusion of spine (disease)?

"Signs of the fusion may include a change in the height of the back, worsening pain or numbness, a gradual stiffness in the back, and an abnormal gait. It is important to note that signs and symptoms of the spinal disease are nonspecific to fusion, and may vary according to the specifics of the condition." - Anonymous Online Contributor

Unverified Answer

How many people get fusion of spine (disease) a year in the United States?

"In the US, fusion surgery is performed on more people annually than people who suffer total disc replacements. The rate of surgically related complications was low in comparison to reports from many countries." - Anonymous Online Contributor

Unverified Answer

What are common treatments for fusion of spine (disease)?

"It's important to note that any treatment will take a time period and that it will take an interdisciplinary team to help get you back on track. \nSpinal fusion is a treatment option that is used to help alleviate the pain and symptoms of spinal diseases such as cancer, degenerative disease, or a deformity. The procedure involves making holes in the bone, implants, pedicle screws, and bone grafts are put in. The surgical procedure depends on the situation as well as preference.\n\n- Bone graft:\nAn implant (pedicle graft), a [spine fusion technique] to add to the fusion of the spine." - Anonymous Online Contributor

Unverified Answer

Is bone marrow aspirate concentrate (bmac) typically used in combination with any other treatments?

"The number of treatments used differed significantly by type of disease (P<0.0001). The most common combinations were TBI (52.8%), BAC/TBI (9.6% and 11.1% for DS and DS/PDS), BAC/R-DME (17.3%), BAC/RMT (9.5%), and BAC/RMZ (9.5%) BAC alone (29%). BAC was also combined with several other treatments, including BAC plus GM-CSF, BAC plus GM-CSA, and BAC plus R-EUS." - Anonymous Online Contributor

Unverified Answer

What is the latest research for fusion of spine (disease)?

"Current surgical methods for spinal fusion (that is spine surgery) are effective. There is new research to [improve the outcomes] and [find alternative technologies to spinal fusion (disease)], such as using [stereotactic body radiation therapy] and [bone grafting] instead of using titanium rods. Future research is needed for [lumbar and cervical fusion of spine.] In May 2017, the Food and Drug Administration approved FLEXfil (Dryoco/Dexidys, a new technique for spinal fusion surgery that uses an artificial disk made of a metal alloy) is the new type of hardware for spine fusion surgery." - Anonymous Online Contributor

Unverified Answer

Is bone marrow aspirate concentrate (bmac) safe for people?

"bmac is not associated with higher rates of cancer or infection in older people with cancer than are similar controls who received placebo or injections of placebo. This finding supports the use of bmac in people with cancer at different life stages." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in bone marrow aspirate concentrate (bmac) for therapeutic use?

"The FDA approved the first FDA-approved use of BMAC infusions in an acute setting for patients with severe aplastic anemia. In the setting of severe aplastic anaemia, an FDA approved BMAC clinical trial showed a 1 year probability of erythropoiesis reconstitution that was comparable to that of a standard of care RBC transfusion. Because B-cell reconstitution is a prerequisite for B-cell reconstitution in a patient with complete leucocyte aplasia, these findings would have significant effects on the field of hematopoietic stem cell transplantation." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating fusion of spine (disease)?

"There have been many new discoveries of some sort with fusion, but there is still no effective therapeutic solution. We don't have to wait for another decade or more before we will get a new treatment for spinal fusion. The Power has helped patients with spinal fusion to create a more functional fused spine, and they are already starting their new and much-needed [power] life." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets fusion of spine (disease)?

"A total of 43,057 people received a fusion of the spine surgery with an average age of 53 and a standard deviation of 13 years. The overall median time of follow-up prior to death was 10.1 years. People who were 50 to 89 were most often alive 4 years after surgery. The age of patients for fusion of the spine surgery was from 0 to 74 years. The age at the time of fusion varied between patients being 28 to 77 years in the years after 2003. At the peak age, the life expectancy was 74 days in males, and 50 days in females. The life expectancy was lower in the younger age." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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