Tag Archives: stem cells

♦ 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.

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♦ 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.

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♦ Patient Power Can Accelerate Access to Stem Cell Therapy

You may know from this blog that Patients For Stem Cells (PFSC) is a grassroots effort by patients who want to advance the progress of stem cell therapy. This therapy is an ideal candidate for the accelerated access programs being called for, from the wave of state laws granting “Right To Try” experimental therapies, to the “21st Century Cures Act” moving quickly through Congress.

AACT.coPFSC is pleased to announce we have joined forces with an organization founded with the goal of accelerating access to life saving cellular therapy, The Alliance for the Advancement of Cellular Therapies (AACT)

We’re inviting PFSC subscribers to join AACT as well. They have generously waived the patient membership fee to kick off this partnership!

To join go to AACT.co, click the Membership option and register for Citizen/Patient Membership – Free!

AACT is organizing the Chicago Stem Cell Showcase Sept 17-18. This is where the doctors and researchers in cellular therapy are gathering to explore “The Dilemma of Difficult Diseases: Cell Therapies to the Rescue?”

The Speakers are medical professionals at the forefront of cellular medicine, They need our support for sticking their necks out, in a regulatory environment that has been less than accommodating. We can do this by building a strong member base for AACT.

Members will get access to resources including:

  • Clinical trial information and statistics
  • Regulatory information and advocacy
  • Informative newsletter
  • Patient forums
  • Access to conference videos

After the Chicago conference, the presentation videos are going to be an incredible education resource for members. Take a look at the packed Agenda, you may see your own illness is going to be addressed by an expert in the field.

Cellular therapy is rarely covered by insurance in the U.S. except for blood cancers. Accelerated access programs are needed in the U.S., similar to what Europe and Japan are already adopting. Starting with difficult diseases for which there are few medical options, like ALS, Parkinson’s, Alzheimer’s, Multiple Sclerosis, Critical Limb Ischemia, Stroke, Heart Disease and many more. Tracking results of patients enrolled in accelerated access can speed approval and insurance coverage.

One of the founding members of PFSC, SammyJo Wilkinson, has volunteered to serve as Patient Advisory Board Chairman for AACT. She is a stem cell patient herself, and knows the frustration patients face. “The AACT patient portal is where patients can get the facts on cellular therapy in plain language. Then they can make better decisions before joining a medical trial, or spending money on therapies not yet covered by insurance. I am thrilled to be part of the PFSC and ACCT partnership!”

SammyJo will be communicating with members as the AACT website develops these resources, and will represent patient opinions to the Executive Board – especially on FDA issues. If you have opinions or want to get involved now in the advocacy process, send SammyJo an email at info@AACT.co

By becoming a member and inviting others to join, you can “AACT Now” to make a difference!

We encourage you to join the discussion in social media and give us your feedback!

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