FDA Public Hearing On Stem Cell Access – Registration Deadline Jan 8th

Wear this T-Shirt to the FDA hearing!  Available from  Bioinformant.

Wear this T-Shirt to the FDA hearing!
Available from Bioinformant.

Update: A huge number of registrations arrived at the FDA. Thank you everyone, your voice is being heard! More info coming soon.
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The FDA has announced a 1 day public hearing to obtain input on the four recently issued draft guidances relating to the regulation of stem cell therapy in the U.S. The restrictive proposed regulations will prevent countless patients from receiving this life-changing treatment. The FDA will consider information from medical professional as well as the public/patients on the finalization of these guidances on April 13, 2016.

Read examples here of how stem cell therapy has been making news for saving patients from disabling, even life threatening illness. The FDA regulations would further limit or stop access to these treatments in America.

WE NEED TO LET OUR COLLECTIVE PATIENT VOICE BE HEARD!!!

Step 1: Register for the FDA Public Meeting

April 13, 2016 8:00 a.m. – 5:00 p.m.
FDA’s White Oak Campus
10903 New Hampshire Avenue
Silver Spring, Maryland 20903
Directions
To register by Jan 8th 2015, send an email to: CBERPublicEvents@fda.hhs.gov

Please register even if you can’t attend in person. We are requesting webinar access for those who cannot travel.
Provide the following info in your email.

1. Full name
2. Titles
3. Affiliation
4. Address
5. Email
6. Phone number
7. Your comment

For Affiliation, here are some suggestions:
• Patients For Stem Cells
• Alliance for the Advancement of Cellular Therapies (AACT)
• Stem Cell Pioneers

Comments are not required, but you can include one about your concerns. Please save it for submitting to the Federal Register. Instruction on how to do this will follow.
Here are some comment examples:

As a “No Option Patient” with a disabling chronic disease, I would like the option to be treated with my own cells, especially when all other FDA approved therapies have failed me. Please consider this when rendering your decision on the minimal manipulation of stem cells.

As a patient who has received cell therapy with quality of life benefits I can attest I wouldn’t be alive today if it wasn’t for the adult stem cell therapy I have received. I should have the right to this therapy here in the U.S. without having to travel offshore.

I am a caregiver of a once vibrant, active and intelligent human being. It is heartbreaking to watch the deterioration of a loved one who could potentially benefit from cell therapy. This a travesty beyond measure.

Step 2: Inform your representative

The FDA is a non-elected appointed regulatory body. Citizens have little recourse to object to the control they are trying to take of the practice of medicine. Please inform your elected Representatives of what is happening.

To find your Representative’s contact and email info, click here.

Step 3: Become an informed advocate

Here is the FDA public notice on the meeting:
Federal Register Notice: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments

You will notice that no attempt is made to translate the technical medical jargon into plain language. That’s why we are very lucky to have the support of AACT, whose directors are some of the leading cellular medicine physicians in the world. The healing they have witnessed in the patients they have treated has motivated them to stand up the FDA.

AACT will be providing updates and further education on the FDA’s actions, as well as further instructions on how to submit comments to the FDA before and after the April 13th meeting. Citizen/Patient Membership is free, but consider a donation if you can.

To join AACT click here: AACT Membership

Here are the topics AACT will be addressing:

    1) Overview of regenerative cells and potential usefulness to medical practice, explaining the scientific data available for us of non-embryonic stem cells, their safety and ethical acceptance.
    2) Forcing US citizens to leave home as medical tourists for untested therapies.
    3) Importance of the physician’s role in the “Practice of Medicine” and the physician patient covenant.
    4) Patient’s Bill of Rights including access to all potential treatments regardless of costs.
    5) Patient’s “Right to Try” laws and the off label use of regenerative cells.
    6) Economic (a) and Academic loss (b) associated with restrictive regressive regulations
    a) Allowing for patient funded clinical studies in the US.
    b) Establishing general and disease specific patient registries designed to collaboratively advance the science and clinical protocols.
    7) Bioethical concerns associated with delaying/denying the aggressive testing and development of quality of life improving and life saving therapies.
    8) The de facto exclusions of these therapies for children in the US.

Thank you for your efforts!

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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