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.
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.
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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