Biologics or biopharmaceuticals are a highly-effective class of medicines that are based on naturally occurring proteins and produced using living cells.
Our Biologics are manufactured from highly refined natural substances, found in the human body using state-of-the-art biotechnology manufacturing techniques with high quality standards.
The Discseel® procedure is comprised of highly purified and exact parts of fibrinogen, prothrombin, the two essential blood proteins involved in the formation of a disc healing. We also introduce an antibiotic into the disc to eliminate infection risk.
Patients will be taller because the disc is going to grow. Patients will have less pain, so they may have to stop taking their pain medicine because they won’t need it. Then last, patients become more active because they don’t have the pain that prevented that in the past. After thousands of surgeries we have had no long-term or serious negative side effects from the Discseel® Procedure.
Any person with long lasting low back pain is a potential candidate. A person with low back pain who’s had surgery or a person with low back pain who prefers to avoid surgery is a potential candidate, because the cushion in the back known as the disc is the most common cause of low back pain.
While a specific amount can’t be given until the doctor evaluates your case, Discseel® Procedure generally costs less than 25% of what a spinal fusion would cost.
The Discseel® Procedure is not currently covered by insurance.
That’s okay and is a situation that many of our patients are in. They’ve had prior surgery, they’ve had fusions, and they’ve had metal inserted into their backs. That’s what we work with, and our goal is to help you have a pain free life.
The cushions in the low back are called discs, and the disc is the most common cause of low back pain. We know that the discs can be injured, degenerated, bulged, and herniated. These conditions need to be corrected, and the best way to correct them is to correct them naturally - not to add hardware, plates, rods, or screws. In the long term, these do not help the patient.
Based on preliminary data we have collected thus far, we know roughly 70% of patients treated with the Fibrin Discseel® Procedure who previously had a failed spinal procedure reported a better outcome in their condition and a positive reduction in pain and function. Recall these are patients who have failed either all or most other treatment options. “Better” is defined as getting better in both function and in pain/symptoms.
The goal is that you only have the procedure once. About 10% of patients return because they either tear the disc again, or they saw some improvement and feel trying it again may give them even better outcomes improvement. On occasion, a patient that does not get better, we offer to help them by considering other options such as diagnostic tests, and if related to disc pain, perhaps trying another biologic such as lumbar PRP or stem cells (harvested from the patient’s Bone Marrow)
It takes millions of dollars to approach the FDA to seek approval. To date, we have not made any attempts to approach the FDA because of costs. We are considering seeking FDA approval once we have trained other physicians to do the procedure, and once the Discseel procedure is offered in many locations. This would allow us to collect very useful data from multiple sites while sourcing the funds needed to apply for FDA approval. Feel good knowing this is an FDA approved biologic that we use off-label, analogous to spine epidural injections of corticosteroid. Those spine epidural injections are not FDA approved, however they are done all the time, and insurance even covers them. Interesting!
We prefer patients to begin walking within a few days after the procedure and continue a daily regime of walking as a lifestyle. We would like patients to avoid bed rest except for the first night we want them to rest in a local hotel unless they live nearby and can rest at home. We would like all patients to avoid flexion (bending over) and rotation (twisting) of the lumbar spine when possible. We remind them that something got them into this position to begin with, which was likely a continuous motion of compressive (flexion) and shear (rotation) forces on the discs over time, so we encourage them to avoid activities that involve flexion and rotation.
You may begin walking a couple of days after the procedure. We do not want you on bed rest. Discs get their nutrients through osmosis, so we encourage all patients to begin walking in small spurts usually on day 2-3 days after the procedure. For the first 4-6 weeks, we encourage walking daily. After the first 4-6 weeks, depending on the patient’s symptoms, they may add other activities into their exercise regime but only at a 10% level and see how they feel afterward. Based on how they feel at a 10% level, hold there for a few weeks, and slowly add to it as they feel better. Use a common-sense approach.
While we do not tell a patient “no”, we have found more patients seem to injure themselves by getting on and off an inversion table from improper body movement, so we say “Use at your own risk but recognize many patients re-injure themselves getting on and off of them.”
Yes, you may have a massage one-week post procedure. You may want to avoid a deep tissue massage the first couple of weeks, but a normal massage is okay. Make sure your massage therapist does not stretch you
You may go back to your chiropractor for follow up care shortly after the procedure so long as they do not manipulate your spine in any way. Please avoid all “popping” and manipulating of your spine. Manipulating the spine may result in tearing a disc if the chiropractor places shear forces on the discs. We like chiropractors and think they are great for offering post-operative care (same with a physical therapist), so please if you consider going back to their care, do so at your own discretion but please ask them to avoid ALL shear and compressive forces on the lumbar and cervical spine.
In the ten plus years of using the specific brand of the fibrin biologic we are currently using, we have never had any adverse reactions or serious events in any patient.
Most patients return to work after about 3-5 days. However, if you need more time off, speak to your physician to see if they are able to write a letter on your behalf to allow you additional time off from work. We strongly advise patients to avoid any heavy lifting for 4-6 weeks.
Patients are free to leave if accompanied by someone after they leave the post-op area. We strongly advise that the patient does NOT drive himself or herself home. Most patients are in post-op for about 30 to 60 min.
While some patients discs immediately plump back up, our goal is not to plump up the discs, but rather, our goal is to promote regeneration of spine tissue where tears reside, thus stopping the disc that have inflamed the spinal nerves and nociceptors (nerves that lives within the outer portion of the disc) from leaking.
Based on our research the majority of our patients “turn the corner” in 3-6 months. However, many patients feel better several weeks following the procedure, and a minority of patients as late as 8-12 months. So it's important to recognize based on past research that we won't know the full outcome of the patient’s procedure until one year out so set the expectations that we do not expect them to “turn the corner for many months.”
The average patient is in their mid 50’s, however we have treated patients as young as 15 and patients in their early 90’s. Our primary demographic is mid 50 year old males however we treat many female patients as well.
No one can answer this question because there has not been enough data collected to show whether or not stem cells add value to healing degenerated spine discs. We believe there is hope with studies that will soon answer this question. One of our partners in NYC has done a small number of Bone Marrow Concentrate (BMC) intradiscal cases and has had positive outcomes. We are currently studying to see whether there is value to adding PRP to the disc after sealing it with fibrin. Dr. Gregory Lutz and Dr. Pauza are currently doing a single-blinded prospective study evaluating this very approach. In the past, Dr. Lutz conducted a double-blinded randomized controlled study looking at injecting intradiscal PRP and it showed very positive results which have maintained for up to two years with a single injection.