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The Healing Miracle….The Truth About Stem Cells Episode 1

Thank you so much for being a part of PFSC. We appreciate each and every one of you and we are honored to provide a voice for everyone battling chronic illness seeking adult stem cell therapy. Tonight premiered episode 1 of the 10 part documentary series on the HOPE and HEALING that adult stem cell therapy can bring to chronic and terminal conditions. This episode is available for 24 hours. PFSC participated in the filming of this project to share our personal stories of success in being treated with adult stem cells, and the ground breaking medical freedom legislation Charlie’s Law, HB810, the state of Texas passed, allowing for the use of expanded adult stem cells to treat chronic conditions. This could help countless no option chronic patients access therapy in Texas. A much better option than going out of the country. Although there are some native Texans who would argue Texas is its own country. PFSC is comprised of people from all over the world. We share the HOPE of adult stem cells with people from all areas, but are grateful Texas lead the way and we are looking forward to helping other states follow. God Bless Texas!!!

As a group we do not profit from the filming or distribution of this project in any way. We are able to share this with you for free. Sign up and a new segment will come to you in your in-box over the next several days.

Thank you for your support,

PFSC Team

Episode 1

A Message of Hope

Happy New Year! Our first post of 2018. Patients for Stem Cells was asked to participate in a docu series on adult stem cells. Follow the link below to view the series. The series was due to release in October. When the producer found out about the passage of the historical medical liberty legislation “Charlie’s Law” in Texas we were contacted and asked to participate. They were gracious enough to delay the release date so we could tell the story of our Texas victory. It was a great honor and we are very grateful to have been given an opportunity to share our personal stories and how Texas led the nation in passing legislation allowing chronic patients to receive adult stem cell therapy in Texas.

There is already a misinformation campaign underway to discredit the series. We stand by the fact that the overall message is a message of HOPE. Countless patients with an array of afflictions have reaped the benefits of adult stem cell therapy. There will always be debate over running it through clinical trials even though we have numerous patients who have received elevation in quality of health. There never seems to be a place at the table for those patients. We at PFSC do not believe our cells are a drug. Therefore, the ongoing debate over running it through clinical trials are irrelevant. We believe this is a decision that should be made between a doctor and a patient and falls solely under the practice of medicine.

It can be exhausting to just make it through the day when you battle a chronic disease. Add to that the need to constantly defend your choice as a patient to seek a non FDA approved effective safe treatment and it can be completely overwhelming. We see this happening within our own families. Some well intended family members express grave concerns because they hear all the rhetoric about adult stem cell therapy and how it is not a proven therapy. We are here to dispel that. The voices of the countless patients who have been successfully treated are strong! We may not be scientist, but we are experts in our health and managing life with a chronic disease. It’s fair to say we all have our PHD’s in what’s good for our own chronic condition! So what is ourPFSC’s job? It’s simple, we are a safe zone. The voice of reason. We understand without judgment. We are here in the trenches living this chronic life with you. We are proud of the project and hope it touches the lives of those who are struggling or simply lost hope. Patients For Stem Cells is a patient based group and we stand united with a clear message of HOPE and HEALING.

Here is a 3 min clip of the upcoming docu series on adult stem cell therapy. The series can be viewed at thehealingmiracle.com. The full release will be January 16th. Please forward and share. It’s important that we get the word out.

View the video at thehealingmiracle.com

Court Battle: FDA vs. Your Stem Cells

Chris Centeno M.D. CEO at Regenexx

Chris Centeno M.D.
CEO at Regenexx

On October 21st, 2013 a very important case comes before the U.S. District Court. USA v. Regenerative Sciences will determine if physicians can use a patient’s own stem cells for life saving therapies here in the U.S. If this case is won, patients will no longer have to seek this therapy as medical tourists at offshore clinics.

Chris Centeno M.D. is the orthopedic doctor from Colorado, whose stem cell treatments for arthritis & injuries brought about the FDA’s regulatory over reaction. He has been standing up to the FDA in court for many years now, at great personal expense. Patients For Stem Cells caught up with Chris for some last minute thoughts before he heads off to court Monday. He will be tweeting the blow-by-blow court action, which you can follow on Twitter @CCentenoMD

PFSC: Dr. Centeno, what in simple terms is this case about, and why should folks pay attention?”

Centeno: Our case is about whether we want a society where some medical innovation is run by the guys in the trenches (physicians) treating patients. If that is beat out of existence by the FDA, will that negatively impact medical discoveries? In that case, we won’t get the best discoveries possible, just the ones that generate enough cold hard cash to pay the FDA piper.

This is about whether the FDA can pretend that a physician using autologous cells in his or her own patients can be regulated like a big pharma company, despite a century of legislation and case law that prohibits FDA from having any control over what a doctor does or how he or she does it. Physicians are already quadruple regulated (medical boards, public health depts, hospital privileges, tort system.) Can FDA quintuple regulate them as to when they use stem cells?

PFSC: What are the specific legal issues?

Centeno:
1. The FDA is prohibited by Congress from having any control over the practice of medicine. This extends right down to the congressional record for each of the FDCA versions (1938, 1962, and modern.)
2. A physician using cells in his own patients isn’t distributing anything and by definition can’t mis-brand (i.e. in US v. Evers a physician can’t fail to give himself proper instructions for use.)
3. Ever since Gonzales v. Oregon, state law trumps federal law when it comes to the practice of medicine-unless something is explicitly laid out by congress as an exception (Scalia – “Congress does not hide elephants in mouse holes…”)
4. The FDA’s midnight 2006 change to extend the 1271 regulations to autologous was ultra vires, as it went beyond the congressional authority outlined in the PHSA (i.e. they turned an organ transplant law into a drug regulation.)

PFSC: Midnight change, that sounds like they were trying to do this so no one would notice!

Centeno: With regard to cell manipulation, the FDA made up these distinctions out of thin air. When applied to allogeneic (donor cells, not your own) tissues grown in bioreactors, these regulations make sense. These tissues can be distributed to millions of individuals who are not consented for the risk of the widely distributed product. Prior to 2006 they didn’t even apply to autologous (your own) tissues. Then the FDA made a midnight change to the regulations without telling anybody (which violated the APA.) They literally changed one word in 1271 so that the regulation went from “into another human” to “into a human”. That one word midnight change is important, as it totally changed everything (Mary Anne Chirba from Boston College of Law has some good writing on this topic). This is because like all regulations, 1271 has to anchor in something congress passed or it’s ultra vires (literally in Latin “beyond the powers.”) There was no anchor law here. The FDA claims that the PHSA gave it authority to classify autologous tissues under certain circumstances (manipulation) a drug, but regrettably it doesn’t. In fact the PHSA exempts autologous tissue, as did the original versions of 1271. This is because the congressional intent of the law is to protect the public from communicable disease transmission in transplants.

PFSC: So what’s the most crucial issue?

Centeno: This was really about the FDA trying to pretend a medical practice can be classified as a drug factory. This is the real issue for the courts to decide. I have discussed above some of the issues about why FDA can’t do this, in fact why they are prohibited by law from doing it.

PFSC: You’ve put many years into this, how do you feel on the eve of the case?

Centeno: I can’t predict how the DC Circuit will rule. I can say that there are many patients who are watching this case. They don’t want a paternalistic FDA telling them what risks they can or can’t take with their own bodies; they want to be able to have free and unfettered access to their own cells.


To find out the impact of what this means to patients, we asked some of our members for comment. Barbara Hanson is Co-Founder Stem Cell Pioneers and also a member of PFSC.

Barbara: Yesterday, I spoke with three terminally ill patients in the course of a two hour period. Emotionally, it leaves me a wreck, to be quite frank. They simply don’t understand how their own government could do this. It’s not as if they haven’t tried every conventional method of treatment either. No option patients should be able to opt for any type of experimental treatment they wish as long as there is informed consent. There is no guarantee that stem cell treatment will help everyone, but to not give patients the opportunity to at least try it does make the government the ultimate life or death decision maker. If Dr. Centeno wins this case, at least this decision will be back in the hands of patients and their physicians, not bureaucrats.

Claire Hooper is a member of PFSC, and moderates our discussion on LinkedIn, where you can join us to discuss this case.

Claire: I was injured in a car accident more than two decades ago. As my back and knees rapidly deteriorated, I began researching alternative ways of treating them. I have already spent a fortune over the last two decades on FDA approved, standard of care medications and treatments for my back and knees, to no avail. Moreover, many of my medications and approved treatments are invasive, risky, and typically lead to additional surgeries and life-long drug dependencies. I find those treatments to be unsafe and unethical. I also find it unethical that, under the current FDA overreach, I will be forced to travel outside the US for autologous stem cell treatments for my back and knee conditions. Dr. Centeno is fighting for our right to have this safe, effective therapy right here in the U.S. Patients everywhere will be rooting for him!


What are others saying about this case?
The Manhattan Institute, a respected legal think tank weighs in.
The FDA’s Misguided Regulation of Stem-Cell Procedures: How Administrative Overreach Blocks Medical Innovation

James Copland, director of the Center for Legal Policy at the Manhattan Institute, summarizes what’s at stake in this Washington Examiner piece.
FDA blocks innovation in adult-stem-cell research

In the Harvard Law Blog two judges, Mary Ann Chirba and Alice A. Noble discuss the case, and FDA regulatory boundaries.
Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies

Following the hearing on Monday, it will take up to three months for the court to issue a ruling. But patients will be following Dr. Centeno’s tweets and his blog as if our lives depend upon the outcome – literally.


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