PRP & ACell Implants now available at US Institute for Advanced Sinus Care & Research

Any topic that is related to ENS, that is not covered in other forum sections.
usasinus
Joined: 07 Jul 2014, 19:18

07 Jul 2014, 19:18 #1

The newly created US Institute for Advanced Sinus Care & Research is now offering platelet-rich plasma injections combined with acellular dermis implants for patients with Empty Nose Syndrome.
We have had positive experiences with our initial patients. Please visit our website at usasinus.org for further information.

The Institute is physically located in Columbus Ohio.  Dr. Subinoy Das, former Director of Sinus Surgery at The Ohio State University, Audit Chair and Fellow of the American Rhinologic Society, and 
winner of the 2013 Fowler Award for the Top Basic Science Research Project in Otolaryngology is the new Medical Director.  The Institute collaborates with leading otolaryngologists throughout the 
world in an effort to provide patients with advanced and rare sinus diseases with cutting edge therapies. For more information, please visit www.usasinus.org or contact Ms. Melanie Clark at usasinus@gmail.com.

 
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usasinus
Joined: 07 Jul 2014, 19:18

21 Jul 2014, 23:40 #2

Responses to Inquiries to U.S. Institute for Advanced Sinus Care and Research

Dear EmptyNoseSyndrome.Org Community,

We have received several inquiries from members of this site and so I hope to reply to many of these common questions in an effort to be helpful and efficient.

1. Who are we and why did we form?

Several forces coalesced to drive the development of our Institute. I received the Edmund Prince Fowler Award for the Top Basic Science Research thesis submitted to the Triological Society, the most prestigious academic society in Otolaryngology, in 2013. My NIH-funded research for the last six years has been trying to ascertain why bacteria cause chronic sinusitis. Through the use of proteomics-based testing and advanced bacterial biofilm analysis, we were able to create a rapid, point-of-care test for chinchillas that could identify whether the cause of a common-cold was due to a virus or bacterial source. As a result, I was encouraged by the State of Ohio to give up my position as the Director of Rhinology at The Ohio State University and develop a startup company (www.entvantagedx.com) to develop this test for humans. My intellectual property was patented, licensed, and so far we have received over 3 million in funding commitments to develop this test. In the course of developing this startup, I met several venture-capitalists, physicians, and patients who were frustrated with the high-cost, low value American healthcare product, a situation that frankly may become worse with the Affordable Care Act, particularly for patients with non life-threatening, rare, or advanced specialty disorders, as opposed to care that may improve for patients with common, life-threatening, preventable diseases, such as diabetes, heart disease, etc. My patients have suffered from the former, which are at risk of being overlooked as insurance companies and the federal government increasingly decide which diseases will be paid for and prioritized in American society. As a result, a group of over 20 physicians, business-leaders, entrepreneurs, industry leaders, patients, and patient advocates have banded together to develop another startup, a private institute devoted to finding cures for advanced and rare sinus disorders. We are in our infancy, and are developing relationships with many top doctors across the country in the field of rhinology and related specialties. Along with our sister company, ENTVantage, DX, Inc., we have invited/are in the process of negotiating contracts with Dr. Harold Pillsbury (past President of the American Board of Otolaryngology and President of the Academy of Otolaryngology-Head and Neck Surgery), Dr. Brent A. Senior (past-president of the American Rhinological Society), Dr. Steven Houser, (upcoming president of the American Academy of Otolaryngic Allergy), Dr. Don Gonzales (founder of ENTrigue and inventor of the septal stapler, serpentine sinus instruments, and holder of over 60 patents), Dr. Amber Luong, (a leading sinus researcher at UT Houston), Dr. Jayakar Nayak (a leading stem-cell sinus researcher at Stanford University), and other world-leaders to serve as the Board of Directors for our Institute.

2. Why have we developed an interest in Empty Nose Syndrome?

Our original interest was to develop stem cell therapies to repair the damaged sinus lining for patients suffering from advanced forms of chronic sinusitis. Currently, stem cell therapy is likely not safe enough for these patients, as there are significant immunology challenges and a risk for cancer or out of control growth created by induced pluripotent stem cells. As a potential bridge to this therapy, we have been studying the value of platelet-rich plasma for our patients. In the development of this technology and in discussions with Dr. Houser, we have realized that the Empty Nose Syndrome community, particularly overseas, is much larger than members of the American Rhinologic Society has realized. We have had several patients independently approach us over the last year and ask for a combination of platelet-rich plasma and Acell Matristem implants. Our initial patients have all had very promising results, and as a result, we cautiously decided to inform this forum about our offering of combined PRP/Matristem implants for treatment of Empty Nose Syndrome.

3. What do you think combined PRP-Matristem implantation is effective? What does the procedure entail? Why so expensive?

Platelet-rich plasma contains many types of growth factors, when concentrated in an area, might induce wound-healing, neovascularization, and new nerve growth. When combined with Matristem, which is a form of collagen created by researchers at Harvard University, we believe that the collagen provides a scaffold of several types of collagen, and the PRP acts as an activator to hopefully induce tissue regeneration in a locally affected area. The procedure entails drawing 60 mL of blood, and using an expensive and patented double-syringe/centrifuge system to enrich platelets. The centifruge takes 5 minutes to spin blood at several programmed cycles and enriches platelets. These are then mixed with the soluble collagen implant and injected into turbinate remnants or nasal floor/septum in an effort to induce wound-healing. The injections have been repeated several times for a few patients. We frankly do not know the optimal injection frequency or other critical parameters for Empty Nose Syndrome, and experiences in orthopaedics are driving our initial parameters. Arthrex, which is the top vendor is this area charges us $15,000 for the centrifuge and $400 for each syringe kit; Acell charges between $100-400 for the implant. In addition, this therapy is considered experimental and unfortunately not covered by insurance companies. To recoup our cost, our prices were set at $1845 and $1500 for repeat injections. These were set by our financial administrators solely in an effort to recoup costs. Zero percent of the cost is used to supplement or defray any administrative or physician salaries for the procedure.

4. What about patients who have not had a turbinate reduction, have had implants already, but still have symptoms of Empty Nose Syndrome? Can they be helped? Why did you diagnose a member with Body Dysmorphic Disorder?

Until recently, much of the teaching and understanding of Empty Nose Syndrome was thought to be related to the creation of turbulent nasal airflow from the over-resection of nasal tissue and disruption of the normal laminar airflow physiology. Evidence of atrophic mucosa and/or crusting were objective symptoms that we would look for on nasal endoscopy to confirm this diagnosis. Recently, research has been performed that suggests that abnormal pressure and/or temperature sensation and disruption of the normal nasal cycle maybe a cause of more of the debilitative symptoms. Dr. Steven Houser, a rhinologist practicing at Case Western Reserve University and likely the top subject matter expert on ENS, and well-known to many in this group, has recently published a paper that underwent rigorous peer-review and was accepted in the Laryngoscope, our top journal in our field, that theorizes on the importance of neural damage in this disease. As as result, we are realizing that many patients who have had septoplasties, open rhinoplasties, mild turbinate reductions in terms of volume, but possibly with over aggressive cautery or radiofrequency etc, may be suffering from symptoms of this disease. While HIPAA laws prevent me from commenting on any personal medical care or confirming or denying any individual medical diagnoses, I have been likely wrong in dismissing the diagnosis of ENS in certain patients with normal-appearing nasal mucosa on nasal endoscopy.

5. Why does the ARS, the NIH, and ENT Community not devote more resources to prevent this disease and/or cure this disease

ENS, as many on this forum are aware of, is particularly devastating because it is often caused by a medical expert in the field of nasal care, and then adamantly denied with the dismissal/double victimization of the patient by the medical community. It is difficult for the ENT community to deal with because the same procedure performed on so many other patients leads to a positive outcome. As a result, the true incidence and prevalence of this disease is likely severely-underestimated by our academic community. I, along with other academic rhinologists, have been selected to select which research grants are funded by the American College of Surgeons, the Triological Society, and other granting organizations, and I myself have been wrong on the prevalence of ENS and likely have dismissed patients with disease in my career. The same holds true for patients who suffer from other rare diseases such as Idiopathic Intracranial Hypertension, Cystic-fibrosis related variants of chronic sinusitis, Wegener's Disease, and others. Our Institute is trying to improve the quality of field of rhinology in directing patients with rare and advanced diseases to the correct subject matter experts in their field in our best attempt to alleviate the suffering from these difficult problems. All patients who receive PRP/Matristem will be prospectively enrolled in a study. We will then submit the results of this study for an oral presentation to the American Rhinological Society tentatively planned for COSM in April 2016, which should have a strong educational impact for this disease.

We hope this helps. We will continue to provide responses from time to time and inform this forum on any new developments in the treatment of ENS when we become aware of them.

Sincerely, Shu Das, MD on behalf of the US Institute for Advanced Sinus Care and Research
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Jonathan
Joined: 30 Sep 2008, 09:46

22 Jul 2014, 16:11 #3

Thank you so much for this information and for your efforts. 
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torrentlink
Joined: 15 Jul 2013, 22:59

23 Jul 2014, 17:51 #4

Thank you for your effort on helping us. 
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torrentlink
Joined: 15 Jul 2013, 22:59

30 Jul 2014, 17:36 #5

Dr Shu:
You are the man! It is really hard to find an ENT who is willing to help ENS sufferers besides you and Dr houser. we are hoping to form an international association and raise some fund to support your rearch. Again. thank you for having a warm heart to help us.
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Jonathan
Joined: 30 Sep 2008, 09:46

30 Jul 2014, 22:33 #6

Dear Dr Das,
Do you think this trial Transplantation of adipose-derived stem cells combined with decellularized cartilage ECM: A novel approach to nasal septum perforation repair could be applied to ENS patients? can be applied to ENS patients?

Are you informed of a nasal spray with growth factors, liposomes and vitamin A and E made by a Spanish chemist, Dr Fernando Barrachina, in Valencia (Spain)? I think it would be a good idea to contact him and see if he can help. 

Thank you so much for your support. 
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usasinus
Joined: 07 Jul 2014, 19:18

01 Aug 2014, 00:43 #8

Dear ENS Forum,
We are looking to initially create a clinical registry of sufferers with ENS. This will require a significant amount of work. We will need to get signed consents, partial HIPAA waivers, and have ENS sufferers fill out detailed questionnaires and validated quality of life surveys. If anyone is interested in assisting us with this endeavor, please contact us at usasinus@gmail.com.

I do feel that transplant of adipose-derived stem cells (likely alone) would be valuable for many of my patients, including those with chronic sinusitis (our main interest with nearly 1 million sufferers in the US alone), patients with septal perforations, patients with ENS, and other patients who have experienced neural/epithelial damage to their nasal mucosa.

Will keep you all informed on our progress..

Best wishes, Shu
Last edited by usasinus on 12 May 2016, 19:55, edited 1 time in total.
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torrentlink
Joined: 15 Jul 2013, 22:59

01 Aug 2014, 00:55 #9

Great, thank you Dr Das. 

Can someone please put this post to the top of the thread? 
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