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Thread: Large animal trial for Chondroitinase is underway

  1. #11
    Quote Originally Posted by GRAMMY View Post
    Anyone wanting to watch the new dog trial posts and photos via Facebook can see it at:

    https://www.facebook.com/ChondroDogsIowaStateVetMed
    Grammy,

    do you know anything about what came out of the pig studies that Acorda was doing in 2011 with Ch'ase (Tony Caggiano at W2W in 2011 said they were doing pig studies)?

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  2. #12
    Quote Originally Posted by paolocipolla View Post
    Grammy, do you know anything about what came out of the pig studies? Paolo
    You can find out here via Phone, Fax or Email: http://www.acorda.com/ContactUs.aspx

  3. #13
    Quote Originally Posted by GRAMMY View Post
    You can find out here via Phone, Fax or Email: http://www.acorda.com/ContactUs.aspx
    I have asked already few weeks ago, but didn't get any reply to my email, so I thought to ask you if you had any info.

    Did you ask too and they didn't reply?

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  4. #14
    Here is an invention similar to ch'ase.

    1. Neurosurgery. 1996 May;38(5):976-83; discussion 983-4. Reduction of extraneural scarring by ADCON-T/N after surgical intervention. Petersen J(1), Russell L, Andrus K, MacKinnon M, Silver J, Kliot M. Author information: (1)Department of Neurological Surgery, University of Washington, Seattle, USA. The effects of ADCON-T/N (Gliatech, Inc., Cleveland, OH), a carbohydrate polymer gel, on peripheral nerve scarring and regeneration were studied in rodents undergoing three types of surgical intervention. Procedure I involved external neurolysis of the sciatic nerve from surrounding tissues and separation of its tibial and peroneal components. Procedure II involved the addition of an abrasive injury. Procedure III involved transection and suture anastomosis of the tibial component. ADCON-T/N or a control gel was locally applied in a blind fashion. Additional animals received no gel, as a further control. Animals underwent second operations 4 weeks after Procedures I and II and 6 weeks after Procedure III. The surgical sites were evaluated using a numerical grading scheme to assess wound healing, sciatic nerve adherence to surrounding tissues, and separability of its tibial and peroneal components. Animals receiving ADCON-T/N demonstrated reduced nerve adherence to surrounding tissues and enhanced separability of the tibial and peroneal components, compared with animals receiving control gel or no gel. Quantitative histological analysis revealed a statistically significant reduction in the amount of dense scar tissue surrounding nerves treated with ADCON-T/N. No evidence of nerve toxicity caused by ADCON-T/N was noted. Counts of regenerating myelinated axons in animals undergoing nerve transection and suture repair did not statistically differ in treated and untreated animals. In conclusion, ADCON-T/N seems to be both safe and effective in reducing extraneural scar formation after peripheral nerve surgery and local trauma.
    Perhaps there are similar problems with the pigs.

    1. Spine (Phila Pa 1976). 2001 Jan 1;26(1):115-7; discussion 118. Unrecognized durotomy after lumbar discectomy: a report of four cases associated with the use of ADCON-L. Le AX(1), Rogers DE, Dawson EG, Kropf MA, De Grange DA, Delamarter RB. Author information: (1)Spine Institute at Saint John's Health Center, Santa Monica, CA, USA. Comment in Spine (Phila Pa 1976). 2001 Nov 1;26(21):2405. STUDY DESIGN: This report describes four cases of symptomatic cerebral spinal fluid leak after lumbar microdiscectomy where ADCON-L was used. OBJECTIVES: To report that ADCON-L may exacerbate cerebral spinal fluid leak from unrecognized, small dural tears after lumbar discectomy. SUMMARY OF BACKGROUND DATA: ADCON-L is a porcine-derived polyglycan that is used with increasing frequency in spinal surgery. It is advocated to reduce postoperative peridural fibrosis and adhesions. METHODS: Four cases of symptomatic cerebral spinal fluid leak after lumbar microdiscectomy were identified. Information on these patients was obtained by chart review. RESULTS: Three patients had small, inadvertent durotomies that were not appreciated at surgery even with the aid of a microscope. The dural violation in the fourth patient occurred at the previous epidural steroid injection site located on the contralateral side of the laminotomy. CONCLUSION: ADCON-L may inhibit dural healing and exacerbate cerebral spinal fluid leak from microscopic durotomies not recognized at the time of surgery.
    1. J Korean Neurosurg Soc. 2010 Sep;48(3):268-71. doi: 10.3340/jkns.2010.48.3.268.
    Epub 2010 Sep 30. Delayed Detected Unexpected Complication of ADCON-L? Gel in Lumbar Surgery. Kim SB(1), Lim YJ. Author information: (1)Department of Neurosurgery, School of Medicine, Kyung Hee University, Seoul, Korea. The ADCON-L gel? (Gliatech, Cleveland, OH, USA), a carbohydrate polymer gel, has been shown in a controlled clinical study to inhibit postsurgical adhesions and improve a patient's clinical outcome. Immediate complication of this gel has been reported in the recent literature including back pain, radiculitis and durotomy. However, delayed detection of disturbance of muscle healing and attachment in late postoperative state has been rarely reported. This report documents an unexpected delayed detected complication of the anti-adhesion barrier gel, which was used after lumbar discectomy one year ago, with review of literature.

  5. #15
    Quote Originally Posted by crabbyshark View Post
    Here is an invention similar to ch'ase. Perhaps there are similar problems with the pigs.
    Chondroitinase isn't a carbohydrate polymer gel used as an anti-adhesion barrier. Maybe hogs leak or have adhesion problems with surrounding tissues, I don't know...

  6. #16
    Quote Originally Posted by GRAMMY View Post
    Chondroitinase isn't a carbohydrate polymer gel used as an anti-adhesion barrier. Maybe hogs leak or have adhesion problems with surrounding tissues, I don't know...
    file:///Users/jerrysilver/Desktop/ADCON%20Clinical%20Paper%20British%20Journal%20of% 20Plastic%20Surgery%20%20%20%20%20%202000-2.pdf

    Post this address in your browser. One of my better achievements.

  7. #17
    Quote Originally Posted by jsilver View Post
    file:///Users/jerrysilver/Desktop/ADCON%20Clinical%20Paper%20British%20Journal%20of% 20Plastic%20Surgery%20%20%20%20%20%202000-2.pdf

    Post this address in your browser. One of my better achievements.
    Thank you Dr. Silver. I'm unfamiliar with the animal studies that led up to the inception of the ADCON gel but I was aware that it's been used in over 300,000 operations and 34 countries have it available. It is indeed a remarkable product and the photo's of the 3 plastic surgery case patients in the publication are super.

    "The use of ADCON-T/N glycosaminoglycan gel in the revision of tethered scars" D. E. Boyce, G. Bantick* and M. S. C. Murison*
    British Journal of Plastic" Surgery (2000), 53, 403405
    9 2000 The British Association of Plastic Surgeons
    doi: 10.1045/bjps.2000.3317

    SUMMARY. Recurrent subdermal scar tethering is a difficult management problem in areas of high tissue mobility.
    We describe a novel solution to this clinical problem, which involves instilling the anti-fibrotic get ADCON|
    T/N in the plane between the skin and the underlying structures. We present our results in three difficult clinical
    situations where excellent results have been achieved using this method. 9 2000 The British Association of Plastic
    Surgeons

  8. #18
    The plastic surgery stuff is not impressive. How do you know that those people wouldn't have gotten better without the use of ADCON at all?

    http://www.locateadoc.com/pictures/s...-repair-c23130

    http://www.realself.com/photo/672300

    Do those people look different than the people in the ADCON study?



    Evidence suggests ADCON is ineffective, if not hazardous.

    1. Eur Spine J. 2008 Dec;17(12):1714-20. doi: 10.1007/s00586-008-0805-8. Epub 2008 Oct 23.Peridural scar and its relation to clinical outcome: a randomised study on surgically treated lumbar disc herniation patients. R?nnberg K(1), Lind B, Zoega B, Gadeholt-G?thlin G, Halldin K, Gellerstedt M, Brisby H. Author information: (1)Department of Orthopaedics, Sahlgrenska University Hospital, G?teborg University, 413 45, G?teborg, Sweden. katarina.ronnberg@vgregion.se A prospective randomised 2-year follow-up study on patients undergoing lumbar disc herniation surgery. The objective was to investigate the relationship between peridural scarring and clinical outcome, the scar development 6 and 24 months postoperatively by using MRI, and if ADCON-L (a bioresorbable carbohydrate polymer gel) has an effect on scar size and/or improve patients' outcome after lumbar disc herniation surgery. The association between peridural scarring and recurrent pain after lumbar disc herniation surgery is debated. Numerous materials have been used in attempts to prevent or reduce postoperative peridural scarring; however, there are conflicting data regarding the clinical effects. The study included 119 patients whose mean age was 39 years (18-66); 51 (47%) were women. Sixty patients (56%) were perioperatively randomised to receive ADCON-L, and 48 (44%) served as controls. All patients underwent MRI at 6 and 24 months postoperatively, and an independent radiologist graded the size, location and development of the scar, by using a previously described scoring system. Pre- and 2-year postoperatively patients graded their leg pain on a visual analogue scale (VAS). At the 2-year follow-up patients rated their satisfaction with treatment (subjective outcome) and were evaluated by an independent neurologist (objective outcome), using MacNab score. There was no relationship between size or localisation of the scar and any of the clinical outcomes (VAS, subjective and objective outcome). The scar size decreased between 6 and 24 months in 49%, was unchanged in 42% and increased in 9% of the patients. Patients treated with ADCON-L did not demonstrate any adverse effects, nor did they demonstrate less scarring or better clinical outcome than control patients. No significant association between the presence of extensive peridural scar or localisation of scar formation and clinical outcome could be detected in the present study. Further, no positive or negative effects of ADCON-L used in disc herniation surgery could be seen.

    1. J Neurol Neurosurg Psychiatry. 2005 Jul;76(7):1031-3. Bilateral subdural haematomata and lumbar pseudomeningocele due to a chronic leakage of liquor cerebrospinalis after a lumbar discectomy with the application of ADCON-L gel. Kuhn J(1), Hofmann B, Knitelius HO, Coenen HH, Bewermeyer H. Author information: (1)Department of Neurology, Kliniken der Stadt K?ln, Krankenhaus Merheim, Ostmerheimerstrasse 200, D-51109 Cologne, Germany. Kuhnj@kliniken-koeln.de The anti-adhesion gel ADCON-L has been available since the end of the 1990s. During disc surgery it can be applied to the spinal nerve roots and the dura mater spinalis in order to inhibit fibroblast migration and thus avoid postoperative adhesions or excessive keloids, respectively. Due to the way ADCON-L works, inadvertent, intraoperational dural lesions may stay open much longer than usual because ADCON-L inhibits the natural healing process. Possible consequences are a chronic leakage of cerebrospinal fluid in combination with intracranial hypotension syndrome. We report on a patient who underwent lumbar disc surgery with application of ADCON-L gel. Postoperatively he suffered from acute headache, nausea, and vomiting. A lumbar pseudomeningocele was demonstrated on magnetic resonance imaging (MRI). Furthermore, cranial MRI revealed bilateral, chronic subdural haematomata which indicated intracranial hypotension syndrome or continuous leakage of cerebrospinal fluid at the lumbar site. With conservative treatment the problems were gradually reduced and eventually the subdural haematomata were no longer detected. The pseudomeningocele persisted over a 4 month period of observation. Because of the complications we found, the local application of ADCON-L during lumbar disc surgery should be critically evaluated.

  9. #19
    Quote Originally Posted by crabbyshark View Post
    The plastic surgery stuff is not impressive. How do you know that those people wouldn't have gotten better without the use of ADCON at all?

    http://www.locateadoc.com/pictures/s...-repair-c23130

    http://www.realself.com/photo/672300

    Do those people look different than the people in the ADCON study?



    Evidence suggests ADCON is ineffective, if not hazardous.


    As usual you have no idea what you are talking about and, also as usual, you like to highlight only the negative. A complication with ADCON can occur when surgeons inadvertently puncture the dura when they perform discectomies. The product works so well that it inhibits the natural scarring process that would usually close small dural leaks. ADCON is being marketed by a company called BiosCompass. They are a wonderful group of people who recently acquired the rights to ADCON and they are committed to bringing a highly beneficial product back to the US market. ADCON works wonderfully well to prevent painful peripheral nerve adhesive entrapments, disfiguring and painful scarring between the skin and underlying structures after deep lacerations, tracheotomies etc (see British Journal paper), abdominal adhesions, pelvic adhesions and adhesions around implants. It works to prevent a devastating condition known as failed back syndrome that can develop after discectomies. And the uses go on and on. Anybody reading this post and knows of someone suffering with pain due to adhesion formation anywhere in the body should contact BiosCompass because they can possibly help with FDA compassionate use.

  10. #20
    Here's a few other human studies mentioned in addition to the British Association of Plastic Surgeons publication.

    Efficacy of Adcon-T/N after primary flexor tendon repair in zone II: a controlled clinical trial. Golash A, Kay A, Warner JG, Peck F, Watson JS, Lees VC. Department of Plastic Surgery, Wythenshawe Hospital, Wythenshawe, Manchester, UK. J Hand Surg (Br) 2003, Apr 28(2): 113-5

    Summary: prospective, double-blind, randomised, controlled trial, 45 patients with 82 flexor tendon repairs in 50 digits. Time to achieve final range of motion was significantly shorter in Adcon treated patients. Rupture rate (esp late) was higher in Adcon patients but this was not significant.

    The use of Adcon-T/N after repair of zone II flexor tendons. Liew SH, Potokar T, Bantick GL, Morgan I, Ford C, Murison MS. Welsh Center for Burns and Plastic Surgery, Morriston Hospital, Swansea, UK Chir Main 2001 Oct; 20(5): 384-7

    Summary: double-blind, randomised trial in 59 patients(Adcon-T/N vs control), early mobilisation. At 6 months, better PIP motion in Adcon group.

    Treatment of recurrent peripheral nerve entrapment problems: role of scar formation and its possible treatment. McCall TD, Grant GA, Britz GW, Goodkin R, Kliot M. Dept Neurological Surg, University of Washington School of Medicine, Seattle, USA. Neurosurg Clin N Am 2001 Apr; 12(2): 329-39

    Summary: retrospective review: prolonged clinical improvement in 67% of patients treated with Adcon-T/N after re-operation of a peripheral nerve versus 50% in the group not treated with Adcon-T/N at re-operation.

    The effectiveness of Adcon-T/N, a new anti-adhesion barrier gel, in fresh divisions of the flexor tendons in zone II. Mentzel M, Hoss H, Keppler P, Ebinger T, Kinzl L, Wachter NJ.
    Dept Traumatology, Hand- and Reconstructive Surgery, University of Ulm, Germany. J Hand Surg [Br] 2000 Dec; 25(6):590-2

    Summary: prospective, randomised, 30 patients with fresh trauma of the flexor tendons in zone II of the hand: excellent results at 12 weeks in 15/16 Adcon-T/N treated patients versus 12/14 control but no statistically significant difference of total active motion and extension lag between the groups.

    The use of Adcon-T/N glycosaminoglycan gel in the revision of tethered scars.
    Boyce DE, Bantick G, Murison MS. West Midlands Regional Plastic and Jaw Surgery Unit, Wordsley Hospital, Stourbridge, West Midlands, UK. Br J Plast Surg 2000 Jul;53(5):403-5

    Summary: excellent results in recurrent subdermal scar tethering by instilling Adcon-T/N in the plane between the skin and the underlying structures.

    Adcon-T/N as an adjuvant in tendon transfers in tetraplegia. Gagliano C, Della Rosa N, Leti Acciaro A, Caserta G, Landi A. S.C.Chir Mano e Microchirurgia, Azienda Ospedaliera Modena, Italia. Poster session at tetaplegia congress in 1999.

    Summary: 3 tetraplegia patients needing tendon transfers in hands were treated with Adcon-T/N around tendons ( 1st in July 1995): no adhesions in any of the patients and good ROM at 4 years, 1.6 years and 2 months post-op.

    Comment am?liorer la chirurgie des tendons de la main. Merle M, Dautel G, Dumontier C. Service de Chirurgie Plastique et Reconstructrice de l’Appareil Locomoteur au
    CHU de Nancy. Review in French in Journal Fran?ais de l’Orthop?die: ma?trise orthop?dique. 1998.

    Summary : extensive review of Adcon-T/N studies and why its use is advocated.

    Peritendinous and perineural scar adhesions. Treatment with a new anti-adhesion barrier gel, Adcon-T/N.
    Merle M, Foucher G, Egloff DV. Service de Chirurgie Plastique et Reconstructrice de l’Appareil Locomoteur au CHU de Nancy. In : Hand Surgery, Rehart S, Zichner L, Thieme Stuttgart, 1997, 33-40.

    Ttendon tenolysis: better functional outcome and no ruptures. With Adcon-T/N postop mobilisation could be postponed resulting in less pain for patient.

    Summary : excellent tolerance, absence of infections and allergies, absence of tendon ruptures, better ROM than control population, most obvious in extensor tendon tenolysis: better functional outcome and no ruptures. With Adcon-T/N postop mobilisation could be postponed resulting in less pain for patient.

    A novel bioresorbable barrier gel (Adcon-T/N)for the inhibition of postoperative peritendinous adhesions: A clinical study in tenolysis procedures of the hand.
    Raffoul W, Egloff DV. Clinique Chirurgicale Permanence Longeraie and CHU Vaudois, Lausanne, Switzerland. Poster presentation at the 20th World Congress of the SICOT, Aug 19-23,
    1996, Amsterdam, The Netherlands.

    Summary: retrospective, with control 32 cases of tenolysis procedures on digits: significantly greater ROM in Adcon-T/N treated patients, no significant adverse effects.

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