Tag Archives: regenerative medicine

Will Real World Patient Evidence Have An Impact On Stem Cell Legislation?

Patients For Stem Cells (PFSC) encourages you to listen to this important webcast regarding the medical innovation bills that are currently before Congress, including the REGROW legislation for cellular therapy. This legislation will determine whether patients have access to life saving cellular therapies in the U.S., or must continue traveling to offshore clinics.

Real World Evidence for Safe and Effective Cures: Medical Innovation for All Americans
The webcast was hosted by the Bipartisan Policy Center (BPC) on June 23, 2016 9:00.

Click here to listen to Webcast, and scroll down the page to access the videos.

We previously covered the impact that Doug Oliver made with his Senator, Lamar Alexander (R-TN). Oliver told his story of recovery from blindness thanks to his own stem cells to Alexander, who is Chairman of the Senate Health, Education, Labor and Pensions Committee. The HELP Committee will be voting in the near future on stem cell legislation like the REGROW bill, which outlines an accelerated approval pathway to cut time and cost of the approval pathway in half. Both Alexander and Oliver will be on the BPC panel.

While PFSC has supported this effort to accelerate approval of cellular therapy, we would like to add two points to the discussion, under the declaration:

Our Cells Are Not Drugs!

1. The REGROW bill reaffirms the FDA’s erroneous jurisdiction over the use of a patient’s own stem cells.

The classification of one’s own stem cells as a drug, makes this therapy subject to the extended drug approval pathway that currently costs $1 billion dollars and takes 10 years. While the bill offers to cut this in half, it is based on the wrong premise that our own stem cells should be considered a drug. This type of therapy is more akin to banking your own blood for a later transfusion. PFSC documented this erroneous regulatory position taken by the FDA in 2012 in The History of FDA Control of Your Body.

Recently, this was further explored by Richard Jaffe, a health care litigator who has worked on many of the most significant, high profile heath care cases of the past twenty plus years, and helped organize and testified at several Congressional Hearings on various issues related to access to experimental medicine.

In an essay titled S 2689: Congress to the rescue on stem cells? (NOT) Richard explains why the REGROW bill would allow the FDA to prohibit some same day autologous stem cell procedures.

“Based on warning letters and recent FDA guidance documents, the clinical use of autologous stem cell therapeutics is essentially over. The only way patients are going to be able to receive autologous stem cell transplants for non-homologous use is either in FDA approved clinical trials or outside the United States.”

An example is the orthopedic treatments currently offered at over 800 clinics across the U.S. This includes procedures where your own stem cells are injected into an injured arthritic hip or knee, at a cost usually under $5,000. Instead of a knee or hip replacement with costs $50,000 to $100,000 and has more risk, pain and poorer outcomes. Putting this on the drug approval pathway would delay access and multiply the cost of a procedure that has already successfully helped thousands of patients avoid disability and stop pain.

eyesTherapies already in use and accumulating safety and effectiveness data should not have to go back to the starting line. This point is clearly underscored by this Fox News article which points out the current move by the FDA further restrict cellular therapy would make cataract treatments illegal!
Cell therapy reversed blindness for 47,000 patients in 2015. So why is it against the law?

2. Just because stem cells are expanded, that doesn’t turn them into a drug.

WalkerswIn January 2016 MD Monthly Magazine published an opinion piece, by one of the founding members of PFSC, SammyJo Wilkinson. She recounted the life-saving cellular therapy she had in 2012 from Houston-based biotechnology company, Celltex Therapeutics. Celltex took her adipose-derived stem cells and cultured them in their state-of-the-art, FDA-regulated laboratory, to reach a therapeutic dose in the hundreds of millions of mesenchymal stem cells, or MSCs. Her first round of therapy was administered in Houston. However, shortly after, the FDA made a ruling that expanded (cultured) adult stem cells constituted a biological drug. Celltex was forced to move therapy to Cancun, Mexico, where SammyJo continued therapy after a year delay.

While Celltex continues to operate a best-in-class cGMP laboratory in Houston, the company exports cells to Mexico, in accordance with the Federal Commission for Protection against Sanitary Risk (COFEPRIS), which is considered the regulatory equivalent of the FDA in Mexico. Cells are used by licensed physicians at Hospital Galenia for therapeutic applications.

Adult stem cell therapy spared SammyJo from 20 years of disabling multiple sclerosis, and impending nursing home care. By 2014 her disease was in remission. Today she is still living at home with her husband. She is pain-free, and four years into recovery. Recently, she reached a milestone with the ability to stand up from her wheelchair and walk 100 feet with a walker.

In her article she quoted one of her long time stem cell heroes, Dr. Andrew von Eschenbach, former FDA director, who is also speaking at the June 23rd BPC Panel discussion. He has gone on record stating:

“Breakthrough technologies deserve a breakthrough in the way the FDA evaluates them. Take regenerative medicine… after proof of concept and safety testing, a product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies.”

The FDA ruling in 2012 claiming that expanded cells are “more than minimally manipulated” was not supported by scientific evidence, and the FDA ignored the fact that the expanded cells that saved SammyJo’s life were identical to the original cells taken from her body.

PFSC is happy to see Real World Patient Evidence given credit, and is happy to add the many success stories we have documented. This is what motivates our grassroots advocacy effort to make this therapy available to all Americans. The current legislative effort needs to take our perspective on FDA over regulation into account. We herewith submit this article as patient testimony to the Congressional hearings on regenerative medicine therapy.

If you agree with the opinions in this article. please express this to your legislators by sending an email in your own words from the one click email for at CellTherapyNow.org

SammyJo Wilkinson
Member, Patients For Stem Cells


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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!

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