Fibrin Sealant for the Treatment of Symptomatic Lumbar Internal Disc Disruption

[Justin]

At the 17th Annual Scientific Meeting of the International Spine Intervention Society (July 22-25, 2009) an abstract entitled "Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter IDE pilot study with 6-month follow-up" was presented by authors Way Yin, MD; Kevin Pauza, MD; Wayne Olan, MD; Jeff F. Doerzbacher, MS4.

The purpose of this study was to assess the safety and preliminary efficacy of BIOSTAT BIOLOGX® Fibrin Sealant in human adults with chronic symptomatic lumbar internal disc disruption (IDD).

The study includes 15 adults with chronic axial low back pain (CLBP). These patients had "failed" conservative therapy and were deemed appropriate for this study after provocation discography for lumbar discogenic pain.

12 patients were treated at a single level, while 3 patients underwent contiguous two-level treatment.

The primary outcome of the study was to measure safety of the BIOSTAT BIOLOGX® Fibrin Sealant and low back visual analog scale (VAS) and Roland-Moris Disability Questionnaire (RMDQ) measurements were recorded over 6 months.

All 15 patients completed the 6-month assessment. Discitis growing mixed flora was the only complication recorded.

• Mean low back pain VAS scores dropped from 72.4 mm to 31.7 mm at 1 month and to 28.0 mm at 6 months. Mean reduction in VAS = 56.2% over 6 months.
  
• Mean RMDQ scores dropped from 15.2 (at baseline) to 10.0 at 1 month and 8.9 at 6 months. Mean reduction in RMDQ = 41.2% over 6 months.

The authors of the study concluded that the BIOSTAT BIOLOGX® Fibrin Sealant "appears to be intrinsically safe in adults with discogenic CLBP and VAS and RMDQ scores suggest intradiscal fibrin sealant injection may improve pain and function in selected patients with symptomatic IDD."

Here's a link for more information on the BIOSTAT BIOLOGX® Fibrin Sealant.

[Carson]

With numerous new technologies on the horizon and so little known as to the likelihood of their long term viability a time machine transport to 2030 to know how these new technologies fare would be helpful. Unfotunately, my DeLoreon's flux capacitor (for any Back to the Future fans) isn't working so I can only research what the present offers.

Of the few newer treatments I've researched this treatment has increasingly occupied the forefront of the possibilities in my mind. There is also a DuraSeal product I want to research. My thinking is, like fix-a-flat, inject the sealant into disk for extra mileage until surgery is needed.

• Has anyone on SPS undergone the fibrin sealant treatment?
• Is anyone actively considering it?
• Does anyone know someone who has?

I'll look around and add what I find to this thread. Thanks, guys.

[Carson]

News Release

Spinal Restoration Initiates Patient Enrollment for Phase III Study of
Company’s Biostat® System

Landmark Study May Have Broad Ramifications for Spine Physicians and Patients
Suffering from Discogenic Chronic Low Back Pain

Austin, TX - March 16, 2010
Spinal Restoration, Inc. announced today that patient enrollment in the company’s Phase III study of the Biostat System for the treatment of discogenic chronic low back pain is now underway. The study, which will be conducted at 15 U.S. clinical sites, is one of only a few multi-center, randomized, blinded, placebo-controlled trials of a nonsurgical treatment for discogenic low back pain ever to be conducted. If successful, the Biostat System Phase III study could have an extensive, far-reaching impact on the diagnosis and treatment of discogenic chronic low back pain—a debilitating health condition that affects an estimated four million adults in the U.S. annually.
Despite the enormous economic burden associated with chronic low back pain, both the diagnosis and treatment of the condition have been challenging for spine physicians. A majority of diagnostic procedures and nonsurgical and surgical interventions have limited or conflicting data to support their utility and efficacy. An article in a 2008 special focus issue of The Spine Journal warned that “we are still in the era of buyer beware” following a detailed review of available treatment options for chronic low back pain.*
“There is high demand within the current healthcare environment for low back pain treatments that have clearly defined indications, unequivocal efficacy data, and the potential to lower the cost of care for patients,” said Gary Sabins, President and CEO of Spinal Restoration. “Our Phase III study of the Biostat System is designed to provide extensive data addressing each of these critical areas and, for the first time, may give spine physicians the information they need to make better, more informed decisions when treating discogenic chronic low back pain.”
The Biostat System study is the first intradiscal biologic therapy for discogenic pain to enter into a Phase III clinical trial.
“The inclusion and exclusion criteria of the study are extremely rigorous, requiring not only a precise diagnosis of discogenic pain, but also the elimination of potential confounding sources of pain through diagnostic spinal injections, imaging studies and physical examination,” added Dr. Kevin Pauza, lead clinical investigator for the study. “The extent of diagnostic measures combined with the randomized, placebo-controlled, blinded design makes this the most ambitious study ever undertaken within the interventional spine community.”

[Carson]

repost

[RonM]

I am a volunteer for this study. I go through the inclusion, exclusion testing this week. They are claiming they are getting pain relief for about a six month period. Has anyone had anyone on here had any experience with this study?

I had thought about trying to get into the stem cell study instead of this one but in the end I flipped a coin to make the choice. Probably not the best way to go about making a treatment decision.

[RonM]

I thought I would share my experience with this study since I was accepted as a participant in case anyone was interested. First of all I have no idea if I received the placebo or the drug so for now I am just sharing my experience with the procedure of the entire thing.

Once they determine you are a candidate with the above mentioned tests and you have time to recover they schedule your trip back to the testing site. For me this ended up being a two day trip. Day one was another MRI and a battery of X-rays followed with informed consent discussion with a case manager and a brief discussion with a doctor. I was there probably for an hour total. They then scheduled the procedure for the following day.

On the day of they had me check into an outpatient surgical center bright and early. I couldn't sleep anyhow from my excitement so I was ready to "rock and roll". They start you on an IV of antibiotics for about an hour. Lots of different people come in and ask various questions that seemed routine. Finally they come in and roll you to the surgical room and roll you over to a surgical table. Everyone had masks and hair nets on and I was thinking there were about eight people in the room. Without warning I was knocked out and the next thing I knew I was in the recovery area and the case manager that I had talked to the previous day was asking if I knew if I had gotten the study drug or the placebo. I said that I did not know but that I was very sore. She told me to sign that I did not know. The doctor came in later and did some checks and they let me go. I am now two days out and still in severe pain, but it is a slightly different nature of pain. I was probably there about three hours total. The first follow-up visit is one week after the procedure.

They said to expect more pain for about 72 hours so I am still hopeful and will remain positive. I will post updates as they occur for anyone considering this. There are several limitations most of which I could not do before.

[Justin]

Hi Ron,

Thank you for sharing your experience with us--it is much appreciated. If would be great to start a thread in the Surgical Outcomes Forum (even though you didn't technically have surgery, it would be a great way to document your experience and would be extremely helpful for others and you'll be able to reflect on your progress as well.

Be well.

I thought I would share my experience with this study since I was accepted as a participant in case anyone was interested. First of all I have no idea if I received the placebo or the drug so for now I am just sharing my experience with the procedure of the entire thing.

Once they determine you are a candidate with the above mentioned tests and you have time to recover they schedule your trip back to the testing site. For me this ended up being a two day trip. Day one was another MRI and a battery of X-rays followed with informed consent discussion with a case manager and a brief discussion with a doctor. I was there probably for an hour total. They then scheduled the procedure for the following day.

On the day of they had me check into an outpatient surgical center bright and early. I couldn't sleep anyhow from my excitement so I was ready to "rock and roll". They start you on an IV of antibiotics for about an hour. Lots of different people come in and ask various questions that seemed routine. Finally they come in and roll you to the surgical room and roll you over to a surgical table. Everyone had masks and hair nets on and I was thinking there were about eight people in the room. Without warning I was knocked out and the next thing I knew I was in the recovery area and the case manager that I had talked to the previous day was asking if I knew if I had gotten the study drug or the placebo. I said that I did not know but that I was very sore. She told me to sign that I did not know. The doctor came in later and did some checks and they let me go. I am now two days out and still in severe pain, but it is a slightly different nature of pain. I was probably there about three hours total. The first follow-up visit is one week after the procedure.

They said to expect more pain for about 72 hours so I am still hopeful and will remain positive. I will post updates as they occur for anyone considering this. There are several limitations most of which I could not do before.

[RonM]

Ok I shared my entire experience so far in the surgical outcomes forum. If it was not done in a correct manner please ax the thread or correct the title/prefix.