Category Archives: Balanced Journalism

♦ Adult Stem Cells Restore Sight To The Blind

March 13th, 2016 – Stem cell patients are making news! PFSC brings together all the reports on Doug Oliver and Vanna Belton, both of whom have regained vision thanks to a pioneering trial led by Dr. Jeffrey Weiss.

First, THANK YOU! to all PFSC subscribers for responding to the FDA Part 15 Hearing registration drive. As hoped, the overwhelming response caused the FDA to postpone the April 13th hearing, and there will be a collaborative workshop w/ stake holders. We look forward to open dialog with the FDA. More info forthcoming as soon as we learn of it.

Now the leaders in the Senate are looking at ways to advance cellular therapy. Patients will be listened to as constituents. At the end of this post, look for information on how you can support this legislation, which is being introduced on March 15th, 2016. [Update: delayed until March 16th, so we have another day to email our Senators.]

Doug Oliver

Doug Oliver

To help readers understand what this legislation could do for the health of Americans, PFSC will run a series of posts highlighting the positive outcomes from clinical trials, and patient stories. For conditions ranging from orthopedics, to stroke and autoimmune diseases. Starting with this story on vision recovery previously thought to be impossible.

Doug Oliver’s vision has been deteriorating since he was 30 due to a form of macular degeneration called Autosomal Dominant Drusen. By his early 50’s, Doug was legally blind, and could no longer drive or see faces.

Doug’s story was covered by Nashville Fox Affiliate WZTV, in a year-long series of reports by Mikayla Lewis which tracked his recovery from legally blind to regaining his driver’s license. His vision changes are documented in his medical records from exams at Vanderbilt University Eye Institute; he has released these records to the public as part of his effort to spread awareness of this treatment.

Highlighted facts of Doug’s case:

  • May 2015, the time of his first television interview with FOX, (before treatment), his vision was 20/400 in the right eye and 20/2000 in the left.
  • Oct 2015, at the follow-up interview (after treatment in Aug 2015), his vision had improved to 20/40 and 20/40 visual acuity range, which is legal for driving.
  • Dec 2015, Doug received his driver’s license.
  • Mar 2016, his vision is 20/30 in his right eye and 20/40 in the left.
  • Mar 11th, 2016 Mikayla Lewis returns to see Doug taking his wife for a drive “Stem Cell Therapy Helps Blind Man See“.

In his latest interview, Doug addresses a common confusion. When people hear “stem cells” they think of therapies that utilize embryos. The reporter includes an explanation by former Senator Bill Frist, MD that research on use of embryonic cells is fading. Adult stem cells from one’s own tissues are proving to be the safer and more effective method.

Vanna Belton

Vanna Belton

Vanna Belton’s vision was 20/3000 in both eyes, after she lost her sight in a matter of weeks in 2009 due to a severe onset of optic neuritis, leaving her completely blind. Vanna is still considered legally blind, but following stem cell therapy in the SCOTS trial in 2014, she can now see enough to no longer need a white cane. Vanna’s case presentation has been published in Neural Regeneration Research Journal, and is currently being submitted for follow up peer-reviewed publication.

The reports on Vanna’s case span the range from positive, factual, to a little histrionic. Patients considering such an investment in experimental therapy that has not yet reached publication or approval need to have all the information available.

The Baltimore Sun report by Meredith Cohn, an experienced health journalist, falls into the balanced journalism category, exploring the pros and cons. The next two reports are from science blogs, recapping Meredith’s story. Science Alert echoes the balanced tone, while the negative terms like “renegade” indicate the Inverse blog is using sensational terms to attract viewers. Yet the author hedges her bets at the end with “Weiss’ work is important because it’s pushing the frontiers of science well beyond what we even think is possible.”

Is this press release the Principal investigator, Dr. Jeffrey Weiss, a board certified retinal surgeon and ophthalmologist, explains the Florida-based Stem Cell Ophthalmology Treatment Study (SCOTS). It is registered with the National Institutes of Health with identifier NCT01920867. It lists the conditions treated by SCOTS, as well as study contacts. The study uses the patient’s own stem cells obtained under anesthesia from the bone marrow. These cells are injected around and potentially in the eye.

In the above media reports Dr. Weiss states 278 patients have been treated, and 60 percent of his 278 patients with macular degeneration, glaucoma and other diseases have regained some sight.

Like many of the cellular therapies offered in the U.S. the SCOTS trial is a patient-funded clinical trial; in this case treatments cost $21,000, which insurance does not cover because the procedure is investigational. Doug raised the funds for the treatment from his local community and through a GoFundMe campaign. Vanna spent her wedding budget to pay for treatment and got married at the courthouse instead.

The SCOTS trial is tracking patient results and submitting early initial case reports like Doug and Vanna’s to peer-reviewed publications. This is the first step in the process leading to publishing the results on all of the patients to determine safety and efficacy. If results warrant it, the therapy could be approved. Multiple trials and many years are usually required for approval, but the new legislation being introduced to the Senate HELP Committee could speed this approval process.

MARCH 2016 CELLULAR THERAPY LEGISLATION INTRODUCED

Senators Mark Kirk and Susan Collins are poised to introduce this legislation, because they recognize the hardship placed on patients with difficult to treat diseases, who are left with no option but to raise funds for cellular therapy, and many have to travel outside the U.S. to received treatment.

Mar 16, 2016: The Kirk/Collins bill will be introduced to the Senate HELP Committee.
Apr 06, 2016: The bill is scheduled for markup (approximate date).

YOU CAN HELP PASS STEM CELL LEGISLATION

Click TAKE ACTION for step by step instructions and draft letters you can email your Senators today. Your story can make it clear why this bill will help patients, whether you are a patient, or know someone who needs stem cells. If you are in a state that has a Senator on the HELP Committee, we urge you to schedule an in person meeting during recess March 27th-April 4th.

Patient For Stem Cells will be monitoring this legislative process and reporting developments as they happen. This may finally bring together all the stake holders, the regulators, legislators, researchers, physicians and patients, so that cellular therapy finally gets the high priority that a breakthrough therapy deserves.

Please use the share buttons below spread this post far and wide so our Senators get plenty of emails!

If you have a stem cell story you’d like us to cover, or wish to report on your interaction with your Senator, please Contact PFSC.

Talk to PFSC members on Facebook | Twitter | Google+ | LinkedIn

Want to become a member of Patients For Stem Cells? Just subscribe to our blog!


 

♦ Stem Cells Bring Happy Holidays In 2015

Julie Walks

Julie_Cerrone overcame Avascular Necrosis of the hip with stem cell therapy and threw down her crutches.

For the past 3 years the focus of the PFSC blog has been to challenge stem cell stories by reporters, weighing if they’ve lived up to the standards of objective reporting. The perspective of patients was often ignored. But as unarguable success stories have accumulated, the media has shifted to human interest stories that report joyful patient recoveries. These news stories, plus some first hand reports from patients, will help readers understand why we are trying to get the word out that stem cells should be given a priority path to accelerated approval, and insurance approval.

Julie Cerrone Julie Cerrone tells her story of overcoming multiple crippling conditions, first by shear determination to take charge of her health, through diet and lifestyle changes. Then with the help of her own stem cells, she healed avascular necrosis of the hip which had her on crutches for 3.5 years. Check out the video of her doing yoga and walking strong – without crutches. She was treated at the Centeno-Schultz clinic.

Tucker & Sarah Sarah Hughes and Tucker Beau Hyatt are two young patients who were considered terminal due to Systemic Juvenile Idiopathic Arthritis (SJIA). Their own stem cells were used, extracted from adipose tissue, and cultured in the lab to reach a high enough dose to quiet the disease. Sarah has gone from bedridden to riding horses in little more than a year. Her story was just featured on CNN Turning Points.

Brooklyn Brooklyn Brumfield was in a wheelchair at age 16 and losing function rapidly from Ehlers-Danlos Syndrome. Since expanded stem cells are not yet covered by insurance, her community rallied to raise $100,000 dollars, a portion of which went for expanded stem cell therapy. A year later she has recovered the ability to walk again, covered by this news story.

Sarah, Tucker and Brooklyn, are recovering from life threatening difficult to treat illnesses. Critics complain this is being done outside of clinical trials, but what family wouldn’t turn to a newly emerging therapy with a good safety record to save their child? Their stem cell banking and expansion was done by Celltex Thearpeutics in Houston, Texas. The cells were administered by doctors at Galenia Hospital in Cancun, Mexico. This blog has documented the FDA’s misguided decision to classify expanded stem cells as a drug here and here. Celltex has been tracking over 800 patients treated since 2011. Patients are looking forward to our data making difference, as outlined in an Open Letter From Celltex CEO Dave Eller.

Jennifer has used stem cells to treat 3 different conditions

Jennifer has used stem cells to treat 3 different conditions


Jennifer Ziegler reports “As many of you know I had stem cell therapy for MS with Celltex in 2012 with great results, which gave me back a more active life. In 2014 I had platelet rich plasma injections in my heel for plantar fasciitis with a full recovery! This past year I had an ACL injury after a skiing accident. Traditional surgery offered me a 9 mo. recovery time. NOT ACCEPTABLE! I’m a busy girl! Using a bone marrow aspirate taken from my hip and AlphaGems, Dr. McKenna at Riordan-McKenna Institute had me hiking, biking, walking and enjoying life after 1 month, total recovery in 6 weeks! I’ve chosen my own cells 3 times now!”

Jennifer is one of the founding members of PFSC, and was featured in the 2013 Business Week stem cell story, and has been interviewed by Healthcare Elsewhere on her MS treatment.
You find Jennifer on Facebook.

Claire Hooper is recovering from knee and back injury after cellular therapy.

Claire Hooper is recovering from knee and back injury after cellular therapy.

Claire Hooper has been a tireless advocate for access to adult stem cell therapy, and she has shared her own treatment experience in Colorado with Dr. Centeno’s Regenexx treatment for knee and back injury which was causing a great deal of pain and disability. Claire has also been interviewed by Healthcare Elsewhere. Read more about the Regenexx clinical trials and published research here.

Debbie Bertrand's interview with Houston TV news.

Debbie Bertrand interview with Houston TV news.


Debbie Bertrand was one of the first MS patients treated by Celltex for long standing multiple sclerosis. This is one of several TV interviews about the improvements she has experienced, like leaving behind her wheelchair once she could use a walker again. She and her husband Larry have become tireless advocates as well, like all the patients in this post. Once you get relief and recovery from a condition that conventional medicine could not help, we feel driven to tell other patients there is hope.

SammyJo Wilkinson presents the case for accelerated approval

SammyJo Wilkinson presents the case for accelerated approval

This is my story about the Celltex stem cell therapy which has helped me put advanced multiple sclerosis into remission since May 2014, with ongoing mobility recovery. I had the honor of discussing the goal of accelerated approval at a conference for The Alliance for the Advancement of Cellular Therapies (AACT). I have also joined them as Chair of the Patient Advisory Board. AACT is a dedicated group of leading cellular therapy physicians who are committed to bringing regenerative medicine to the patient bedside. Contact me via Facebook.

Doug Flomer demonstrates mobility recovery after stem cells.

Video of Doug Flomer demonstrating his mobility recovery after stem cells.

Doug Flomer decided to get treated with the Celltex therapy, after he saw the recovery his wife SammyJo had from MS. He suffered from an autoimmune disease, rheumatoid arthritis, which was causing pain, weakness and swollen joints in his hands. He saw a rheamatologist who advise fusing his finger joints. Instead he had an IV infusion in 2012 of his own stem cells and remains in pain-free remission. He also had a direct injection for a painful hip injury, which restored his ability to move again without pain.

All the patients featured in this post were treated over a year ago or longer, illustrating lasting recovery. Orthopedic conditions often respond well to a single treatment, while long standing or difficult to treat disease can require repeat dosing to achieve remission. This therapy is in the early stages and not yet covered by insurance. When weighing if you should spend your own money on cellular therapy, please exercise good due diligence. Here is a list of suggestions for doing research.

Further Resources

Stem Cell Pioneers is a discussion forum where patients help each other evaluate therapy options, and they host the excellent Ask The Doctor Q&A where the experts answer patient questions.

Choosing a stem cell clinic: A consumer checklist from The World Stem Cell Summit

Healthcare Elsewhere features many more interviews and stories about patients seeking therapy. Use the search for “stem cells”.

Watch for our next post that will explain how you can make your voice heard by the FDA on patient access to stem cell therapy.

For more stem cell news Like us on Facebook
Follow us on Twitter @PFSCToday
Want to join Patients For Stem Cells? Just subscribe to our blog!


 

4 part series published in Lamar University Press on evolving role of stem cell therapy in American medicine.

Graphics by William Jones and Chelsea Henderson, Lamar University Press

Graphics by William Jones and Chelsea Henderson, Lamar University Press

Reported by Chelsea Henderson, named University Press editor at Lamar University in 2012, where her work has earned Excellence in Media awards. Chelsea has done a remarkable job of investigative reporting over the the past year on stem cell therapy. Interviews covered all stakeholders, including patients like PFSC members Claire Hooper and SammyJo Wilkinson, to explore the controversy that has arisen following the FDA’s determination that patients cannot utilize their own stem cells in the U.S., forcing them to resort to medical tourism abroad. Chelsea also tracked down regulators, doctors and scientific experts, to examine the scientific facts, and the restrictive regulations that no-option patients see as a death sentence.

The different types of stem cells are explained in clear language and illuminating graphics, starting with embryonic and man-made engineered induced pluripotent stem cells, which haven’t even entered human trials yet. Then autologous adult stem cells are examined, which have been in use for many years. The patient interviews she conducted reveal recoveries from conditions like multiples sclerosis and cerebral palsy, with positive results these patients had never been able to obtain with traditional medicine.

These reports represent the balanced reporting that Patients For Stem Cells has found to be lacking in much of the press stories on stem cells. This series stands as a comprehensive primer for anyone who needs to come up to speed on this important topic.

Stem cells spark controversy
October 23, 2013

FDA wary of ‘biological drugs’
October 30, 2013

Patients seek to reclaim stem cells
November 6, 2013

Handley leaves US for stem cells
November 13, 2013

Interview With The Author

PFSC How did this story come about, what caught your interest?

CH I began researching stem cells after my boss told me about his friend, an artist and Lamar University graduate, who was raising funds for stem cell treatment during the summer of 2012. She had multiple sclerosis, which I knew nothing about, so I wanted to educate myself about her disease, as well as how stem cells could be used as treatment. At this point in time, my research was only supposed to prepare me for that one article. But the more I discovered, the more gaps I found in the research and the less things made sense. I couldn’t understand how the scientific community could present the full potential of stem cells, there were patients all across the globe who were more than willing to use their own cells to heal their degenerating bodies, and somehow, the FDA had banned patients from doing so. That’s how my one story about an artist with MS turned into a two-piece story package and a four-part series.

PFSC What surprised you the most in your discovery research on stem cells?

PFSC When I began researching stem cells a year and a half ago, everything was new to me. I had no prior knowledge going in – I had never even heard of stem cells before. Once I became more educated, I was infuriated by how stem cells are regulated in the United States. The most surprising thing, however, was how the Food and Drug Administration handles inquiries about stem cells. Heidi Rebello, FDA Office of Media Affairs’ deputy director of operations, was the only FDA representative out of the 18 I contacted who agreed to answer my questions. Even then, all she did was paraphrase parts of the Code of Federal Regulations and send me a link to the full text. It was frustrating and complicated, and the only thing I could think during that lengthy process was, “Wow. If they’re making me jump through this many hoops just for some information, how are they treating sick patients who just want access to use their own cells?” This made me push even harder, and really helped turn writing this series into a civil rights issue.

PFSC Do you think you yourself will bank your stem cells, as insurance for future medical use?

CH I would love to bank my stem cells for future medical use. Without insurance coverage of such a procedure or any extra funds to speak of, however, this security is not an option for me at this time. If I ever needed to use my own stem cells, I would have to raise funds in order to travel abroad. I, like so many suffering Americans today, would be forced to engage in medical tourism just to access my own cells.

PFSC Knowing what you know now about the FDA regulations of our stem cells, do you agree or disagree with those regulations?

CH I absolutely disagree with how autologous stem cells are regulated. I understand why embryonic and induced pluripotent stem cells are regulated the way they are, and the FDA is 100 percent correct in doing so. However, I see no reason for the FDA to regulate autologous stem cells they way it does. The only danger I can see in using autologous stem cells is in mixing them with potentially harmful substances. But after interviewing stem cell patients, I am confident in saying that the ones that want to use their own stem cells – not embryonic or induced pluripotent – do not want a stem cell cocktail. They want to use their cells, and I see no reason for the FDA to interfere with that.

To help spread awareness, share this post by clicking the share buttons below.
Like us on Facebook
Follow us on Twitter @PFSCToday
And more stories on Pinterest
Join the stem cell discussion on LinkedIn
Want to become a member of Patients For Stem Cells? Just subscribe to our blog!