Spinal Disc Fibrin Injection -- Clinical Study

[Harrison]

We know that Linda and others have recently had fibrin injection procedures recently. I've been very interested in this new procedure for lots of different reasons, but have been swamped and unable to look into this interesting approach. So, to start off with a link and a question -- how many clinical trials do you see that are open, accessible, but not recruiting patients? See the clinical trial link here.

Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study
This study is ongoing, but not recruiting participants.

Sponsored by: Spinal Restoration, Inc.
Information provided by: Spinal Restoration, Inc.ClinicalTrials.gov Identifier: NCT00693784
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I also found this excerpt from a research report of interest:

Tissue Sealants
Baxter International, Inc.

Baxter’s BioScience business provides biopharmaceuticals derived from human plasma or recombinant technology to treat hemophilia, immune deficiencies, and other blood-related disorders. This business segment also provides vaccines for the prevention and treatment of certain infectious diseases, as well as biosurgery products. Baxter’s biosurgery products include the following:

(1) FloSeal™ Hemostatic Matrix, a high viscosity gel that stops bleeding in less than two minutes;
(2) CoSeal® Surgical Sealant, a synthetic sealing agent for vascular reconstruction; and
(3) Tisseel® VH, a fibrin sealant that consists of a two-component
fibrin biomatrix with highly concentrated human fibrinogen to seal tissue and stop diffuse bleeding.

Baxter’s Tisseel® VH fibrin sealant contains a bovine fibrinolysis inhibitor, aprotinin, which may lead to severe allergic reactions.

On June 20, 2007, Baxter announced that it signed licensing agreements with Intercytex Group (ICX.L-LSE) and Spinal Restoration, Inc. to evaluate Tisseel® VH as a drug delivery vehicle in various regenerative medicine therapies, including as a combination therapy with Intercytex’s ICX-SKN, an investigational skin replacement therapy, and Spinal Restoration’s Biostat Biologix™ Fibrin Sealant, which is specifically for the intervertebral disc area of the spine.

Also see: http://www.spinalrestoration.com/products/biologx.html

[Harrison]

Mechanical analysis of the effects of bacteria and aprotinin on skin wound healing in adult guinea pigs
Wound Repair Regen. 1993 Jul;1(3):187-93.

Wayne Stadelmann, MD; Daniel Greenwald, MD; Lisa Stevens ; Scott Shumway, MD ; Karen Leoni, MS; Thomas Krizek, MD. From the Sections of Plastic Surgery at the University of Chicago, Chicago, Ill.; Massachusetts General Hospital, Boston, Mass.; and the University of South Florida, Tampa, Fla. Correspondence to Reprint requests: Daniel P. Greenwald, MD, 910 South Newport, Tampa, FL 33606.

ABSTRACT
Inhibition of wound healing by bacteria may result in part from the conversion of plasminogen to plasmin. This conversion results in dissolution of the fibrin seal in a wound or between skin graft and bed. Aprotinin blocks conversion to plasmin, preserving the fibrin clot.

The current study was undertaken to determine the effects of high concentrations of bacteria on wound healing and how these effects are mitigated by aprotinin. Dorsal full-thickness skin incisions were made in 40 anesthetized guinea pigs and closed with nylon sutures.

Animals were divided into four groups: (1) control wounds,(2) infected wounds, (3) wounds treated with aprotinin, and (4) infected wounds plus aprotinin (single dose). Animals were killed 3 and 4 weeks after the operation. Skin strips containing segments of the healing wounds were pulled apart by a tensiometer until rupture. Stress-strain curves were generated, and wound strength and toughness were determined.

All wounds, including those inoculated with bacteria, appeared healed. The 3-week infected group healed with the least strength and toughness (p < 0.001). A single dose of aprotinin administered with the bacterial inoculum reversed this inhibition. In the 4-week groups, the strongest and toughest wounds resulted from bacterial inoculation alone. Aprotinin alone augmented wound healing when compared with controls. These data suggest that wound healing in both clean and infected wounds is augmented when the plasminogen-plasmin pathway is inhibited.

Courtesy of: http://www3.interscience.wiley.com/j...TRY=1&SRETRY=0

[Harrison]

OK, so it took 16 years to figure out that this helps spine patients heal?! Well, better late than never. The ramifications of this are earth shattering, industry-rocking and mostly HEALING.
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Bactericidal activities of lysozyme and aprotinin against Gram-negative and Gram-positive bacteria related to their basic character

A. Pellegrini U. Thomas , R. von Fellenberg P. Wild Institute of Veterinary Physiology, Division of Applied Veterinary Physiology 1 Institute of Veterinary Anatomy, Laboratory of Electron Microscopy, University of Zürich, Zürich, Switzerland Correspondence to Institute of Veterinary Physiology, Division of Applied Veterinary Physiology, University of Zürich, Winterhurerstrasse 26, CH-8057 Zürich, Switzerland.Copyright 1992 The Society for Applied Bacteriology

ABSTRACT

A. PELLEGRINI, U. THOMAS, R. VON FELLENBERG AND P. WILD. 1992.

Bactericidal properties of aprotinin, a proteinase inhibitor and possibly a defence molecule in bovine species, and of chicken egg white lysozyme, known as muramidase, were investigated. Incubation of various bacteria in the presence of either aprotinin or lysozyme showed that both proteins killed Gram-positive as well as Gram-negative bacteria without addition of complement or EDTA. Denaturation of the two proteins by dithiothreitol did not lead to loss of their bactericidal potency.

Electron microscopic examination of Escherichia coli incubated either with lysozyme or aprotinin revealed that the bacterial cytoplasms gradually disintegrated. Both aprotinin and lysozyme were demonstrated within the affected cytoplasm by immunogold labelling. The results suggest that the bactericidal potency of lysozyme is not only due to muramidase activity but also to its cationic and hydrophobic properties. The bactericidal activity of aprotinin is probably also related to both these properties rather than to its activity as proteinase inhibitor.

Courtesy and source: http://www3.interscience.wiley.com/j...88875/abstract

[steve55]

I have seen Linda's story where she finally found complete relief with the Fibrin procedure, and it seems there are a few others who have found relief with this procedure and thus didnt have to have an ADR or fusion. I know its new, but Im so surprised to see so little about it here and its not even mentioned anywhere on spinehealth.net or any other internet searches I have done.

Well, if anyone cares to add what they know about this new procedure, please do. After my discograjn with Dr Ziglar, Im sending my results and MRI to Dr Pauzin's Research coordinator to see if I am a candidate.

[KBear]

Glad you posted this, because I am very interested in hearing more on it too. Was your discogram the 'easy' kind like I had? (ie. sedation, then being waken then being sedated again.)

[phylly]

I am also interested in what you find out about fibrin. It sounds like a miracle right now. I wonder how many success cases are out there?
Phylly

[Harrison]

Hi all, I've merged Steve's new topic (from Dec. 30th) into the previous one for continuity -- see the rest of the topic I created in November. Hope this helps!

[steve55]

Originally Posted by KBear

Glad you posted this, because I am very interested in hearing more on it too. Was your discogram the 'easy' kind like I had? (ie. sedation, then being waken then being sedated again.)

I havent had my discogram with Dr Ziglar w/ TBI as of yet, I took the 400 question Psyche test today(yikes, what a beat down that was). But I guess based on what you just said, mine will be very much like the discogram I had with Dr Peloza last summer, ......a cake walk

[steve55]

Originally Posted by Harrison

Hi all, I've merged Steve's new topic (from Dec. 30th) into the previous one for continuity -- see the rest of the topic I created in November. Hope this helps!

Good call Harrison! I must have missed the existing Fibrin thread when I originally posted my question about it. I spoke with the fibrin coordinator that another board memebr posted here and she says to get my discogram with Dr Ziglar done first and then Ill send all my charts over to them and see if I am a candidate.

I have quite a dilemma though. Currently I have Aetna who will cover my ADR with Dr Ziglar, but 2 month from now, my employer changes carriers to Humana. I havent read anywhere that humana is ADR friendly, so if I waste too much time trying out this Fibrin thing, I might miss my chance for the insurance covered ADR. What to do.(Sigh) Im hoping thinks move fast enough to where I can just extend cobra (probably $500 /mo)with Aetna for 2-3 months if necessary to see if this Fibrin thing works first. It will be interesting to see what direction I ultimately go.

[Adrienne]

Count me among those interested!