Clinical Papers Hemostats Reviewed - Oxi Cell, Gelatin, Collagen, Thrombin, Polysaccharide Powders

A lot of our earlier embedded  document links have gone since our previous embedding agency sold (these things happen in 5 years of blogging). Now Google have this facility I am happy to provide you clinical data for your interest in the links below. 

J&J's Ethicon recalls blood-stopping hemostat; FDA warns of deadly risk

Johnson & Johnson unit Ethicon is recalling its some of Surgiflo hemostatic kits, warning that a packing issue could lead to breaches in the product, and the FDA has assigned its most serious label to the recall.

Surgiflo is a topical, absorbable hemostat used to stop bleeding in surgical procedures. Ethicon became aware of the packing problem back in the spring and is urging customers to return the affected lots once they're identified. The FDA has branded the affair a Class I recall, saying the recalled products could be rendered non-sterile and their use could to lead to serious injury or death.

Ethicon says it is yet to receive any reports of adverse events from Surgiflo, but the FDA is asking customers to report any problems through its online MedWatch system.

Ethicon has a long history of regulatory dustups, including the costly and deadly vaginal mesh debacle and an October Class I over malfunctioning surgical staplers. However, the company last week won FDA approval for its Evarrest Fibrin Sealant Patch, and J&J has committed to spending $185 million to expand Ethicon's suture-making plant in Athens, GA.

- Here's the FDA's notice

3 Chinese drug makers recall 13 chromium-tainted (porcine)gelatin products

Three pharmaceutical companies have recalled their chromium-contaminated drug capsules after authorities suspended sales of 13 types of problematic medicines.
Tonghua Yason Pharmaceuticals in Northeast China's Jilin province said the company decided to recall all tainted products made since 2010.
"Pharmaceutical producers do not possess the capability to examine capsules, so we just simply checked the quality report provided by capsule suppliers and then let them go," an anonymous official with the company's product quality department was quoted as saying by stcn.com, a website run by Securities Times.
But the company said the producer of the problematic capsules was a Zhejiang-based company and was not among those exposed by media.
China Central Television revealed in an investigative program on Sunday that nine pharmaceutical companies were packaging medicines with capsules made with industrial gelatin, which contains a much higher degree of chromium than edible gelatin.
The industrial gelatin was made from waste leather at plants in Jiangxi, Zhejiang and Hebei provinces, according to the report. (Pictured above:  Huge piles of substandard leather scraps at the warehouse of Xueyang Gelatin and Glair Factory in Hengshui, Hebei province, were used to make gelatin that was sold to capsule makers. Wang Min / Xinhua).
Normally, capsules are made with material from animal bones.
Excessive intake of chromium can result in chronic diseases. 

Jilin-based Huinan Tianyu Pharmaceutical posted a statement on its website saying that it is recalling the batch of products exposed by CCTV, but "those products were not problematic because they were produced in 2009 and they accorded with the standards set in related code released in 2000".
The Chinese Pharmacopoeia, amended in 2010, permits no more than 2 milligram of chromium per 1 kilogram of medicine. Before that, the cap was 5 mg per 1 kg for heavy metal, but it had no specific stipulation about chromium, said the announcement.
The company's products were found with 3.54 mg of chromium per 1 kg of medicine.
Dandong Tongyuan Pharmaceutical in Northeast China's Liaoning province also announced the recall of its chromium-contaminated products, according to China News Service.
Xiuzheng Pharmaceutical Group in Jilin said in a statement on its website that the company has suspended sales of the problematic products but said "the capsule suppliers we pick are quality firms that meet all the country's standards and we are re-examining those products".
After the chromium scandal was exposed, websites for three pharmaceutical companies involved, including Xiuzheng, were hit by hackers.
Song Xunjie, a manager with Xueyang Gelatin and Glair Factory in Hebei province, was detained on Monday by police and suspected of setting fire to his factory to eliminate evidence.
The fire did not cause any casualties. The factory had suspended production and police sealed 200 tons of products there.
The factory mainly sold products in Beijing and Zhejiang, as well as cities such as Changzhou, Jiangsu province, and Xiamen, Fujian province, according to Xinhua News Agency.
Sun Zhongshi, an expert with the National Rational Drug Use Monitoring System under the Ministry of Health, said the drug watchdog paid more attention to the quality of medicine inside the capsules rather than the capsules themselves, and should draw a lesson from this scandal.

SOURCE: China Daily

Human Gelatin...

Gelatin is found in everything from Jell-O and marshmallows to cosmetics and candles. But the current method of taking gelatin from the skin and bones of cows and pigs has a number of drawbacks, including variation in quality from batch to batch, the potential for transmitting infectious diseases like Mad Cow and the possibility of triggering immune system responses in humans. We may not have to rely on pig bones for  gelatin forever, though the newest option--human derived gelatin--isn't too appetizing.
Beijing University of Chemical Technology researchers created the slightly creepy productby sticking human gelatin genes into a strain of yeast that can produce gelatin with reliable features--and a virtual guarantee that it won't be contaminated with pathogens or cause immune responses (because the gelatin molecules are based on human DNA sequences). No word on when the gelatin will be available for commercial use, but there are other companies working on similar products.

ArterX™ Clinical Trial Results Announced at Veith Meeting

MOUNTAIN VIEW, Calif., Nov. 18, 2010 /PRNewswire/ -- US clinical trial results for Tenaxis' investigational vascular surgical sealant, ArterX, were presented today at the Veith Meeting in New York.  William M. Stone, MD of the Mayo Clinic, Scottsdale AZ reported a more than 20% margin of improvement for ArterX Surgical Sealant in the sealing of vascular suture lines compared with a control group featuring a commercially available gelatin foam/thrombin combination.
In a presentation titled "A Novel More Effective Glue-Sealant (ArterX) for Hemostasis at Vascular Suture Lines and Other Sites," Dr. Stone reported that ArterX Surgical Sealant achieved immediate hemostasis more than 60% of the time in a 217 patient clinical trial conducted at 11 different hospitals in the US.
President and CEO, David Smith, commented, "We are delighted with the preliminary results of our US clinical trial.  We were also able to show a statistically significant reduction in operating time of 36 minutes in the ArterX group, and ArterX patients were discharged from hospital after 4.1 days, an improvement of 1.3 days over the control group. If approved, we believe that ArterX Surgical Sealant will yield economic benefits for surgeons and hospitals that adopt it."
ArterX Surgical Sealant is currently under review by the FDA and is not available for sale in the USA.
ArterX is CE marked for the EU.

Interesting Thrombin Paper

Clinical use of Topical Thrombin as a Surgical Hemostat. Click to Enlarge - includes commentary on Oxidised Cellulose, Collagen and Gelfoam.

Orthovita Powerhouse validates future Hemostasis Growth

Orthovita have released convincing data relaying their belief in the Orthopedic hemostasis market......see below......

Clinical Benefits and Risks of Topical Hemostats: A Review

You may view or download by clicking on the thumbnail.

Recombinant collagens and synthetic gelatins

FibroGen is the only producer of highly purified, fully characterized recombinant collagens and synthetic gelatins intended to replace similar animal- or plasma-derived materials currently used in a variety of medical, pharmaceutical, and consumer applications. The company's fermentation system enables the large-scale production of medical-grade materials. FibroGen's collagens and gelatins are fully synthetic materials that eliminate the risk of contamination with disease-causing pathogens such as viruses and prions. Currently FibroGen's products are intended for laboratory research purposes only and are not to be used in humans or for any other purposes, including but not limited to, in vitro diagnostic purposes, foods, drugs, medical devices or cosmetics or animals or for commercial purposes.

FibroGen - a company trying to commercialize synthetic collagens and gelatins

Recombinant human collagens and gelatins
Based on expertise in collagen and the role of prolyl hydroxylase enzymes in the formation of collagen, FibroGen has developed the first known recombinant methodology for making fully synthetic collagens that are essentially identical to those found in nature. By making and testing different types of collagen that exist in nature, FibroGen scientists have demonstrated that recombinant type III collagen persists longer in tissue than any form of human or animal type I collagen. This unique characteristic of type III collagen serves as the basis for FibroGen's dermal filler product candidate for cosmetic applications.
Focused efforts over several years have also led to the development of a highly efficient production system employed by FibroGen to supply recombinant human collagens and gelatins (collagen fragments) as biomaterials for use in a variety of pharmaceutical and medical device applications. FibroGen produces recombinant human type III collagen (never before available in commercial quantities), recombinant human type I collagen, and distinct recombinant gelatin molecules optimized for specific applications. FibroGen's biomaterials address the needs of a wide range of customers in the pharmaceutical and medical device industries for safer, highly pure, and fully characterized alternatives to animal-sourced collagen and gelatin.

Risks of infected animal and human derived Devices

The FDA has recently changed its position with regard to the use of gelatin. A guidance document has been issued regarding the use of gelatin in FDA-regulated products for human use (Attachment 4). The guidance pertinent to medical devices reads:
"Gelatin produced from bones and hides obtained from cattle residing in, or originating from, countries reporting BSE or from countries that do not meet the latest BSE-related standards of the Office International des Epizooties (OIE) should not be used either in injectable, ophthalmic, or implanted FDA regulated products, or in their manufacture."
The guidance also states:
"At this time there does not appear to be a basis for objection to the use of gelatin produced from bovine hides and bones in FDA products for human use if the gelatin is produced in the United States from US-derived raw materials or from cattle born, raised and slaughtered in other countries that have no reported BSE cases and that meet OIE BSE standards."

Bovine Spongiform Encephalopathy (BSE) is a degenerative disease which affects the central nervous system of cattle. It is similar to other transmissible spongiform encephalopathies (TSEs) such as scrapie in sheep and Creutzfeldt-Jakob Disease (CJD) in humans. At this point in time the incubation period of BSE appears to be from 2 to 8 years. There is currently no treatment, nor is there a validated test to detect the disease in a live animal. Diagnosis is determined by microscopic examination of brain tissue. The nature of the BSE agent is widely theorized to be a prion, an abnormally folded version of a normal cellular protein. The abnormal protein then recruits additional molecules of normal protein and facilitates their conversion to the abnormal form. The agent is extremely resistant to traditional forms of disinfection and sterilization. As new information on the diagnosis, treatment and nature of the agent becomes available, this guidance will be modified as appropriate.
Epidemiologic data suggest that the BSE epidemic in Great Britain which began in 1986 occurred through feeding cattle contaminated meat and bone meal as a protein source. The BSE agent may have been present for a long time, but changes in rendering procedures in the late 70's and early 80's may have enabled the active agent to survive in the animal feeds. The agent is thought to be from scrapie-infected sheep, but cattle with a previously unidentified TSE have not been ruled out. An association between cases of variant CJD in Great Britain and BSE seems likely, although causality has not been proved. To date, there have been no cases of BSE in the United States.
The possibility of introducing the BSE agent through a medical device requires special attention on the part of manufacturers with regard to the sourcing and processing of bovine-derived material. At present this can most easily be accomplished by assuring that the source cattle are free of BSE. In 1993 and more recently, on May 9, 1996, the Food and Drug Administration (FDA) issued letters to manufacturers to request that bovine-derived materials from cattle which have resided in or originated from countries where BSE has been diagnosed not be used in the manufacture of FDA-regulated products. (Attachments 1, 2 and 3)
Since 1989, the USDA has restricted the importation of live ruminants from Great Britain. Currently the USDA restricts the importation of live ruminants from countries where BSE is known to exist, and from those countries that present a significant risk of introducing BSE into the United States. Also restricted (by USDA) from import from these countries are other ruminant-derived products such as bone meal, meat and bone meal, blood meal, offal, glands, and gelatin for animal consumption. FDA recently prohibited protein derived from mammalian tissues to be used in ruminant feed for animals in the US (Federal Register June 5, 1997; 21 CFR Part 589 "Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed").
To track medical devices which either contain or are exposed to animal-derived materials during manufacturing (e.g., human cells grown in media containing fetal calf serum), CDRH has developed the CDRH Biomaterials Database which contains an inventory of these devices, including type of material, animal species and country of origin, and target organ or tisssue for each device. Originally proposed in response to the BSE issue, the Database was expanded to include all animal-derived products (including human) in order to respond to other animal material-based sourcing concerns that may arise in the future.