Tag Archives: adult stem cells

Texas Stem Cell Legislation 2017 – Action Alert

TXCap UPDATE June 2017 THANK YOU to everyone who wrote and called the Texas Legislature! HB810 Charlie’s Law was signed by Gov. Greg Abbott. The Texas Board of Health will define rules starting in Oct. 2017. Here is a news report as of Sept. 25, 2017 The future of stem cell therapy in Texas
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May 13th, 2017 – There are currently bills before the Texas Legislature that would allow access to adult stem cell therapy in the State of Texas, rather than by travelling outside of the U.S.

This week advocacy members of Patients For Stem Cells testified before the Texas House of Representatives in support of these bills, and we are happy to report House Bill 810 by Rep. Tan Parker, passed the Texas House with 150 yes votes and zero no votes.

An emotional speech by Rep. Drew Springer, R-Muenster, about his wife’s need for a medical cure from stem-cell research, brought together this unanimous, bi-partisan vote.

Now the Texas Senate needs to hear from their Texas constituents! The next step is the Senate vote, and we have advocates at the Capitol who will deliver your testimony.

If you live in Texas, please send the following information:

1. Your full name, city, state & zip code

2. Why you think adult stem cell therapy should be allowed in Texas. Maybe you or a loved one has a terminal or chronic condition that could be treated by stem cells. Or you just want to support medical freedom.

Send your email to: PatientsForStemCells@gmail.com

Deadline before Senate vote: Tues, May 16th, 2017

Please click here to find your Senator and also call to express your support for the HB 810 stem cell bill.

For everyone who doesn’t live in Texas, rest assured that this legislation may well start a trend for other States to follow. We will keep you informed as this movement expands, and look forward to your participation!

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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.

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


 

The History of FDA Control of Your Body

May 18th, 2013


(Click image to watch video)
sm1For the first time in history the FDA has encroached into the practice of medicine. The FDA made autologous adult stem cell therapy subject to the same regulatory oversight as mass-produced pharmaceutical agents. Without compliance to the Administrative Procedures Act requiring an “extensive public comment period.“ The FDA managed to expand it’s authority, without input from patients and their doctors…

sm2In the early 1990’s, the cells in your body were like any other body part that could be used by a physician and moved from one area to the next. They were body parts like a kidney or a heart. That was before an unprecedented power grab by the FDA.

sm3In the late 1990s, the FDA proposed that the cells in your body should be made drugs. They were met with stiff resistance. They ultimately decided, that if the cells were at all made more potent by growing them to bigger numbers, they would be drugs, even though they were still your cells. This was known as the “minimal manipulation” rule later codified in 21 CFR 1271.1-3. In the 1990’s this only applied to someone else’s cells that were manufactured like drugs, so this made some sense.

sm4The FDA, without the proper notice and comment making period required by the Administrative Procedures Act, made a one word midnight change in the 2006 federal register. It changed a single word from “another” to “a”. By doing this, it’s regulatory authority was expanded from simple control over someone’s cells used as a transplant from “another” person to all cells from “a” person. With this one work change, FDA granted itself sweeping new authority over your body.

sm5Up until 2008, it was assumed that FDA only meant to apply it’s rules to pharma companies who were processing cells. Then in 2008, FDA went after a physician’s office that was using the patients own cells and treated the small doctor’s office like a large Pharma company. This necessitated a suit by the doctor’s office against FDA, but this chain of events now extended FDA’s authority even further, as now your local family doctor was suddenly under the same cell based regulations as Pfizer.

sm6In 2010 and 2011, the FDA decided to place fat tissue processed at the patient’s bedside to release stem cells into the same category as prescription drugs. They made this intention clear through letters to several parties that asked the Tissue Reference Group whether this simple processing of fat was something FDA intended to control. In addition, it submitted Warning Letters to Intellicell and a Dr. Young, codifying it’s intent to turn fat tissue into a drug.

sm7So as you can see, FDA has gone from no control over your body’s stem cells as drugs in the 1990’s, to classifying an ever increasing number of you body tissues as drugs. This is despite massive opposition from these industry groups.

♦ American Red Cross
♦ Society for Assisted Reproductive Technology
♦ Osiris Therapeuticsc Inc.
♦ Northwestern University
♦ Hyman, Phelps & McNamara
♦ Biotechnology Industry Organization
♦ American Society of Clinical Oncology

What is the impact of classifying simple medical procedures as prescription drugs? The FDA has taken procedures that should by now be routinely performed as the practice of medicine, and instead placed them into a glacially slow drug approval process. Countless sick patients have been denied access to their own stem cells that may well cure or mitigate their disease.

sm8Share this page with your friends. Ask your local university if they have a focus on adult stem cell research, specifically autologous mesenchymal stem cells, expanded to a therapeutic dose. Educate your state and congressional representatives. Citizens need to take charge of the way their body parts are being regulated.

 

Further Reading:

FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!” Alliance For Natural Health, January 31, 2012

Why Can’t We Use Our Own Stem Cells to Heal Our Bodies? by Berkley Bedell, former Congressman and founder of The Foundation for Alternative and Integrative Medicine (FAIM)

FDA Stem Cell Regulation and the English Language: switched at birth? Mary Ann Chirba, J.D., D.Sc., M.P.H. August 11, 2011

FDA Oversight of Autologous Stem Cell Therapies: Legitimate Regulation of Drugs and Devices or Groundless Interference with the Practice of Medicine? Mary Ann Chirba, J.D., D.Sc., M.P.H.

Does the FDA have regulatory authority over adult autologous stem cell therapies? 21 CFR 1271 and the emperor’s new clothes The Journal of Translational Medicine 2012 10:60