[Tn-talk] Fwd: SCOTS Stem Cell Ophthalmology Treatment Study

Mon Oct 10 19:31:01 UTC 2016

James Alan Boehm
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Blindness never limits-low expectations do! Live the life you want!

> Begin forwarded message:
> 
> From: Karen Davis-Ahng <Karen.Davis-Ahng at tn.gov>
> Subject: FW: SCOTS Stem Cell Ophthalmology Treatment Study
> Date: October 10, 2016 at 1:30:34 PM CDT
> To: "jimmydagerman80 at gmail.com" <jimmydagerman80 at gmail.com>
> 
> Jimmy,
>  
> Below is information about a research trial being conducted in Florida where they are using a patient’s own stem cells to try to repair certain genetic and other eye conditions, such as Retinitis Pigmentosa (RP), some retinal injuries, some optic nerve traumas, etc.  I thought you might be interested to know about it and might want to share with others you know. I am forwarding an email excerpt below that was sent to me by someone who had the procedure this month. Another man in Cookeville, whose news story is linked to far below in the article from the doctors doing the procedure, says that man improved from hand motion to driving again in about 6 months after having the procedure, though it apparently does not work for everyone with his genetic eye condition of RP. The procedure, since it is in research trials, is not covered by insurance, and it’s my understanding the cost at this time is about $20,000 plus travel expenses, etc. But, as with many medical procedures, if enough people benefit from the trials, it may very well one day be covered by insurance, so it’s something we may all want to keep on our radar.
>  
> Karen in VIS at TRC
>  
> From: *********
> Sent: Monday, October 10, 2016 12:48 PM
> To: **********
> Subject: FW: SCOTS Stem Cell Ophthalmology Treatment Study
>  
> Hi all,
>  
> Below is the information about the Stem Cell Ophthalmologic Treatment Study that I participated in last week.
>  
> Dr. Levy, the director of the study explains a lot and lists several conditions that can be treated by this study in the e-mail to me below, and there are a number of links to publications about the study as well as to the National Institute of Health’s information about the study.
>  
> I hope this helps everyone understand the study a bit better.
>  
> One lady who was there with me could read the eye chart at 5 feet on Monday before the surgery, and by Friday, four days after the surgery, she was able to read some of the eye chart at 20 feet.  She was 84 years old and had macular degeneration as well as glaucoma.
>  
> Happy reading!
>  
> Begin forwarded message:
> 
> From: <stevenlevy at mdstemcells.com <mailto:stevenlevy at mdstemcells.com>>
> Date: June 8, 2016 at 6:49:35 PM CDT
> To: **************
> Subject: SCOTS Stem Cell Ophthalmology Treatment Study
> 
> Dear ************,
>    We appreciate your interest in stem cell treatments for eye disease.   We are recruiting for a study that will evaluate the efficacy of such stem cell treatments called the Stem Cell Ophthalmology Treatment Study or SCOTS.  You may review at www.clinicaltrials.gov <http://www.clinicaltrials.gov/>  Identifier NCT01920867. After reviewing this email if you have any questions or want to discuss the procedure and study, please call me at 203-423-9494 during business hours EST (Eastern Standard Time United States ).
>  
> RP is eligible for SCOTS.  RP is not a single disease.  There are 60 separate genes that can cause RP - the most common can have over 600 different mutations.  We have had patient have rather strong improvements- most recently a patient improve from Hand Motion to 20/150 in a month.  We have also had patients have minimal or no improvements.  We cannot predict an individual response at this time. 
>  
> If you would like an evaluation we ask that you email 2 items: 
>  
> 
> 1) If not already provided-
> Patient Name and Date of Birth
> 
> Patient Email and Telephone (mobile preferred)
> Brief History of eye problem
>  
> 
> 2) You may then email a recent eye exam  providing visual acuity, description of the eye, diagnosis and any visual fields. You may also send via fax 203-905-6800
>  
> 
> Other special studies such as photos, Fluorescein Angiograms, OCT, ERG etc are not required because SCOTS inclusion criteria (as listed on NIH)  are based on the eye exam and visual fields (if available).   Once received the exam(s) will be forwarded to our principle investigator who will review and indicate if he believes the patient falls within the guidelines and could potentially benefit from the treatment.  You will then be notified by email - although you are welcome to call.  We strongly prefer any eye exams be sent as a email attachment.  However if you or your ophthalmologist wish to fax any examinations please fax to 203-905-6800. 
>     
>    The treatment is a transfer of active bone marrow derived adult stem cells to an area that has sustained cellular damage. Eligible ophthalmic conditions include retinal diseases such as dry and wet AMD - Age Related Macular degeneration, Myopic Macular degeneration, other hereditary type macular degenerations, hereditary retinopathies such as Retinitis Pigmentosa , Stargardts, Cone-Rod, Rod-Cone, Cone dystrophy, Bests dystrophy, non-perfusion retinopathy, retinal injury, retinal inflammation such as POHS or choroiditis, certain diabetic retinopathies, and optic nerve conditions such as Glaucoma, optic nerve ischemia/ neuropathy/ optic neuritis/optic atrophy/ optic compression / and some trauma.  
>    Our observation of prior treatment  results has been positive in several retinal and optic nerve conditions with improvements in visual acuity and peripheral vision.   Visual improvements have been noted to begin within a short period of time or take several months- depending on the patient, disease and degree of visual loss.  They have varied but about 25-30% improvement or  4 lines of central vision improvement has been seen - for example from 20/200 to 20/60 (metric 6/60 to 6/18) or 20/50 to 20/20 (metric 6/15.1 to 6/6). Improvements in visual fields (peripheral vision) both of Mean Deviation and Pattern Standard Deviation have been seen as well as contrast sensitivity, color vision and the lifting of the fogginess that patients often complain about.  As each patient is different, the informed consent states that results cannot be predicted with certainty and you should understand that SCOTS is designed to determine efficacy of the procedure.  The Stem Cell Ophthalmic Treatment Study is designed to evaluate and allow us to report on the efficacy of this treatment.
>    The treatment includes the pre and first post op eye exams, the stem cell procedure at the licensed surgical center including anesthesia by their board certified anesthesiologists, bone marrow aspiration by our orthopedic surgeon, processing of the bone marrow aspirate to isolate the stem cells using an FDA cleared medical device / CE certified ( Europe)  and eye treatment with your own bone marrow derived adult stem cells by Dr. Weiss- our board certified, fellowship trained retinal surgeon.
> 
>    There are three groups of treatments or arms of the study which may be reviewed on the NIH website.  The administration of the stem cells may include retrobulbar (RB), subtenons(ST), potentially intravitreal (IVIT) or intraocular (IO) .  Intravenous (IV)  is also  provided.  For Arm 1 consisting of RB+ST+IV or Arm 2 consisting of RB+ST+IVIT+IV the cost is $19,600.oo USD.  For Arm 3 consisting of RB+ST+IVIT+IO+IV the cost is $21,600.oo.
>     All final therapeutic decisions are made by you and our retinal surgeon after his direct examination and evaluation, as well as informed consent.
>  
>     We are very proud of this outstanding group of physicians and surgeons performing state-of-the-art adult stem cell treatment for eye disease at the ParkCreek Surgery Center, Coconut Creek, Florida. We believe this offers an opportunity for visual improvement depending on the eye disease and represents the most advanced approach to adult stem cell treatment for ophthalmic disease available anywhere in the world.  The Stem Cell Ophthalmic Treatment Study is designed to evaluate and allow us to report on the efficacy of this treatment. 
> 
>    Travel, hotels, meals and the required pre-op clearance and testing by your medical physician are not included.  Currently the next available treatment dates are July 19 and August 2, 2016.  These will change as patients fill the schedule.   If we need to move a previously scheduled patient, an earlier date may be available.  Arrival would on the weekend just before the treatment , full exam with the retinal doctor on Monday , treatment Tuesday, post-procedure visit Wednesday and again on Friday.  Patients may then travel home on the weekend.   Non-US patients should be mindful of any visa requirements.  
>  
> To get more information:
> On the www.clinicaltrials.gov <http://www.clinicaltrials.gov/> website - search NCT 01920867 or type in SCOTS and find the eye study.
> Scroll to   More Information 
> and click on  The Role of Patient Funded Clinical Research in Advancing Medical Care  
>  
> Please review our initial papers, television reports and previous press releases:
>  
> Principal Investigator Interview on Fox news broadcast WSVN 7 News
> Seeing is Believing: South Florida Doctor Helps The Blind See Through Experimental Procedure <http://www.wsvn.com/story/31421005/seeing-is-believing-south-florida-doctor-helps-the-blind-see-through-experimental-procedure>
> http://www.wsvn.com/story/31421005/seeing-is-believing-south-florida-doctor-helps-the-blind-see-through-experimental-procedure <http://www.wsvn.com/story/31421005/seeing-is-believing-south-florida-doctor-helps-the-blind-see-through-experimental-procedure>
>  
> ABC news broadcast WMAR
> Baltimore woman once blind, regains vision after retinal stem cell surgery <http://www.abc2news.com/news/in-focus/baltimore-woman-once-blind-regains-vision-after-retinal-stem-cell-surgery#st_refDomain=&st_refQuery=>
> http://www.abc2news.com/news/in-focus/baltimore-woman-once-blind-regains-vision-after-retinal-stem-cell-surgery#st_refDomain=&st_refQuery= <http://www.abc2news.com/news/in-focus/baltimore-woman-once-blind-regains-vision-after-retinal-stem-cell-surgery#st_refDomain=&st_refQuery=>
>  
> ABC news broadcast WPLG
> Retina surgeon breaks new ground in fight against vision loss <http://www.local10.com/video/retina-surgeon-breaks-new-ground-in-fight-against-vision-loss>
> http://www.local10.com/video/retina-surgeon-breaks-new-ground-in-fight-against-vision-loss <http://www.local10.com/video/retina-surgeon-breaks-new-ground-in-fight-against-vision-loss>
>  
> SCOTS patient Doug Oliver crafts legislation with US Senator Lamar Alexander interview on WJHL
> Blind Man sees after stem cell treatment, crafted bill to help others get access to treatment. <http://wjhl.com/2016/05/31/blind-man-sees-after-stem-cell-treatment-crafted-bill-to-help-others-get-access-to-treatment/>
> http://wjhl.com/2016/05/31/blind-man-sees-after-stem-cell-treatment-crafted-bill-to-help-others-get-access-to-treatment/ <http://wjhl.com/2016/05/31/blind-man-sees-after-stem-cell-treatment-crafted-bill-to-help-others-get-access-to-treatment/>
>  
> First medical journal publication:
> Stem Cell Ophthalmology Treatment Study (SCOTS) for retinal and optic nerve diseases: a preliminary report
> http://www.nrronline.org/article.asp?issn=1673-5374;year=2015;volume=10;issue=6;spage=982;epage=988;aulast=Weiss <http://www.nrronline.org/article.asp?issn=1673-5374;year=2015;volume=10;issue=6;spage=982;epage=988;aulast=Weiss>
> 
>  <http://t.co/NRqK0mFh4v>Second medical journal publication:   
> Stem Cell Ophthalmology Treatment Study (SCOTS) for retinal and optic nerve diseases: a case report of improvement in relapsing auto-immune optic neuropathy
> http://bit.ly/mdstemcells10715 <http://bit.ly/mdstemcells10715>
>  
> The Role of Patient Funded Clinical Research in Advancing Medical Care
> 
> bit.ly/mdstemcellsNIH <http://https/www.clinicaltrials.gov/ct2/show/NCT01920867?term=nct+01920867&rank=1>
> (scroll to bottom of NIH site under Additional Information to access)
>  
> 
> Glaucoma Visual Fields Improve Following Stem Cell Treatment
> http://www.pr.com/press-release/614581 <http://www.pr.com/press-release/614581>   OR  http://prlog.org/12444395 <http://prlog.org/12444395>
>  
> SCOTS is mentioned in the article titled:
> Progress of mesenchymal stem cell therapy for neural and retinal diseases. 
> http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3999769/ <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3999769/>
>  
> Optic Nerve Regenerates Following Stem Cell Treatment
> http://prlog.org/12314576 <http://prlog.org/12314576>
>  
> In the Columbus Dispatch Newspaper with video of patient:
> Stem-cell treatment may help those with severe vision problems
> http://www.dispatch.com/content/stories/life_and_entertainment/2014/03/27/relief-in-sight.html <http://www.dispatch.com/content/stories/life_and_entertainment/2014/03/27/relief-in-sight.html>
>  
>  
> Top 10 Stem Cell Advances in 2013
> http://prlog.org/12261445 <http://prlog.org/12261445>
>  
> Leber Hereditary Optic Neuropathy and Stem Cell Eye Treatment
> http://prlog.org/12256869 <http://prlog.org/12256869>
>  
> 5 Things You Need To Know About Stem Cell Treatment for the Eyes
> http://prlog.org/12254493 <http://prlog.org/12254493>
> MD Stem Cells Reports On SCOTS New Stem Cell Surgery for Optic Nerve Disease  
> http://bit.ly/16R0QDN <http://bit.ly/16R0QDN>
>  
> MD Stem Cells Shares SCOTS New Stem Cell Surgical Technique for Age Related Macular Degeneration    http://markets.pe.com/pe/news/read?GUID=25353654 <http://markets.pe.com/pe/news/read?GUID=25353654>
>  
> MD Stem Cells Indicates Government Shutdown Will Not Impact SCOTS Eye Stem Cell Treatment Study http://prlog.org/12219335 <http://prlog.org/12219335>
>  
> MD Stem Cells Begins the Largest Stem Cell Eye Treatment Study to Date    
> http://bit.ly/15J86TK <http://bit.ly/15J86TK>
>  
> MD Stem Cells Shows Retinal Eye Disease Responds to Stem Cells With Significant Vision Improvement        http://bit.ly/11XZnZn <http://bit.ly/11XZnZn>
> 
> MD Stem Cells Continues Billion Cell Treatments for Eye Disease  http://www.pr.com/press-release/490668 <http://www.pr.com/press-release/490668>    
> 
> http://www.pressking.com/press-releases/Eye-Doctor-Finds-Impressive-Vision-Improvements-from-Stem-Cell-Treatment-Reports-MD-Stem-Cells-057124 <http://www.pressking.com/press-releases/Eye-Doctor-Finds-Impressive-Vision-Improvements-from-Stem-Cell-Treatment-Reports-MD-Stem-Cells-057124> 
> 
> 
> http://www.pressking.com/press-releases/MD-Stem-Cells-Macular-Degeneration-Patient-Continues-to-Improve-Following-Stem-Cell-Treatments-052762 <http://www.pressking.com/press-releases/MD-Stem-Cells-Macular-Degeneration-Patient-Continues-to-Improve-Following-Stem-Cell-Treatments-052762>
> 
> 
> http://www.biospace.com/News/md-stem-cells-very-elderly-benefit-from-stem-cells/288338 <http://www.biospace.com/News/md-stem-cells-very-elderly-benefit-from-stem-cells/288338>
> 
> http://www.biospace.com/News/md-stem-cells-begins-intravitreal-stem-cell/287886 <http://www.biospace.com/News/md-stem-cells-begins-intravitreal-stem-cell/287886>
> 
> http://www.biospace.com/News/md-stem-cells-release-billion-cell-milestone/286928 <http://www.biospace.com/News/md-stem-cells-release-billion-cell-milestone/286928> 
> 
> http://www.biospace.com/News/md-stem-cells-release-optic-nerve-vision-loss/285669 <http://www.biospace.com/News/md-stem-cells-release-optic-nerve-vision-loss/285669>
> 
> http://www.prlog.org/12055424-myopic-macular-degeneration-improves-with-new-stem-cell-treatment.html <http://www.prlog.org/12055424-myopic-macular-degeneration-improves-with-new-stem-cell-treatment.html>
> 
> http://www.prweb.com/releases/2012/11/prweb10187261.htm <http://www.prweb.com/releases/2012/11/prweb10187261.htm> 
> 
> http://www.prweb.com/releases/2012/11/prweb10131236.htm <http://www.prweb.com/releases/2012/11/prweb10131236.htm>
>  
> 
> I look forward to being of assistance.  
> 
> 
> Kind regards,
>  
> Steven Levy MD
> SCOTS Study Director
> President, MD Stem Cells
>  
> Jeffrey Weiss MD
> SCOTS Principle Investigator
> Retina Associates South Florida
>  
> Contact:
> stevenlevy at mdstemcells.com <mailto:stevenlevy at mdstemcells.com>
> 203-423-9494 ( East Coast USA)
> Steven Levy MD
> 