Written by Heidi Stevenson   

== The FDA is protecting Big Pharma from the competition of autologous stem cell therapy, no matter what the cost to individual lives. Here's the proof: two true stories of lives transformed with stem cells.

At its best, modern medicine does wonders, and the new technique of autologous stem cell therapy, which uses one's own stem cells to grow new tissues, is a prime example. Ciaran Finn-Lynch is an 11 year old boy who is alive because he breathes through a new trachea grown from his own cells. Andrew Kent's leg would have been amputated, had it not been for the same technique.

In the United States, the FDA bans the same technology.

That's right. The FDA would not have allowed Ciaran's trachea to be grown from his own stem cells, consigning him to a slow death of asphyxiation because he was born with a windpipe that was too narrow. Andrew would have lost his leg when it was crushed in an accident.

The FDA says that each time a cell line is grown from one's own stem cells, it becomes a drug because a medical claim is made for it. So, the FDA has decided that each time a cell line is grown from a person's cells, it must go through the full testing process of a new drug.

In other words, the FDA won't allow autologous stem cells to be used because they are competition for Big Pharma.

== Ciaran Finn-Lynch's Story ==

Ciaran is a Northern Ireland boy who was born with a trachea (windpipe) that is too narrow. He'd been through surgeries that implanted stents to keep his airway open, but they would erode, causing massive bleeding. He was running out of time.

At Great Ormond Hospital in London, he was treated by National Health Service doctors. They took stem cells from his hip, injected them into a donor windpipe that had been stripped to its collagen core, and a new windpipe was grown—one that was a perfect match for Ciaran because it grew from his own cells. It was then transplanted into Ciaran's chest. The surgery was called a success when his own blood supply transfused the new organ.

After rounds of surgery and a bleak outlook, Ciaran has gone home to look forward to a normal life. Professor Martin Elliott of Great Ormond, who led the transplant team, issued the following statement:

"The tracheal team at Great Ormond Street Hospital is delighted that Ciaran is going home after his tracheal transplant. He is a wonderful boy who has become a great friend to us all, and he and his infinitely patient family have charmed us all. Ciaran has become our local iPad expert, and we will miss his advice. His recovery has been complicated, as one might expect for a new procedure, and we have kept him under close surveillance, hence the length of time he has been here. It is wonderful to see him active, smiling and breathing normally. We are very proud of him!

"Ciaran will continue to need regular follow up by us. This is so we can both make sure he is ok, and also learn what to expect for the next patient who needs this innovative therapy. The treatment offers hope to many whose major airways were previously considered untreatable or irreplaceable. We will continue to work with our colleagues in regenerative medicine throughout the world to ensure we can continue to improve both the science and treatment options."

== Andrew Kent's Story ==

When Andrew and his son were hiking and climbing in the Lake District, a boulder fell on his leg. It was broken in five places, so badly that it couldn't be helped with surgeries. The wound became badly infected. He was in serious trouble, and the next step would have been amputation of his right foot.

However, doctors tried something new. They took stem cells from bone marrow in Andrew's hip, mixed them with a collagen gel, pinned the bones in his legs together, and then injected the mixture into the fractures. He is expected to achieve a full recovery. Mr. Kent says:

"Receiving that news [of needing an amputation] is pretty devastating. You think: 'I don't want to lose this foot. That would be horrendous'. Now I'm very pleased. I can wiggle my toes and they are looking good."

Orthopedic surgeon, Anan Shetty, placed his full weight on the knitting bones, and they remained solid. He stated:

"He has really surprised us. This is an amazing technique. He won't be able to run for about a year, but after 18 months his bones will have healed completely. I'm sure he'll be able to go back and rock climb again."

The same technique is also being used to heal knee injuries.

== Back in the USofA ==

In the US, Ciaran would be dead or dying, and Andrew Kent would be learning to get around on one leg. It isn't because the ability to utilize autologous stem cell therapy is unavailable. It's because the FDA won't allow it.

--Your product is a drug.

In June, the FDA sent one of its infamous "your product is a drug" letters to Regenerative Sciences, Inc. for its product called Regenexx™, which is a procedure that draws stem cells from a patient's hip, then grows them, after which they're reinserted into the patient. The letter states:

"The Food and Drug Administration (FDA) has reviewed your website at Internet address: http://www.regenexx.com and has determined that you are promoting your use of mesenchymal stem cells under conditions that cause these cells to be drugs..."

There we go again! By magic, Presto Change-O! Your product is a drug!

The FDA has decided that Regenexx is a drug, along with Cheerios and walnuts. What's worse, though, is that each individual case in which a person's stem cells are used is considered a different drug. That means the FDA is saying that a full drug approval process must be undergone each time stem cells are taken and grown for use on that same person. That process typically costs millions of dollars and takes many years.

--You didn't roll over, so we're gonna sue.

This was just the first step against Regenerative Sciences. The FDA is now seeking an injunction against them for adulterating their stem cell product. Of course, what the FDA calls adulteration is the intended process. Further, the FDA claims that the products are "misbranded" because of "lack of adequate directions for use" and "failure to bear the 'Rx only' label. These are not products that enter pharmacies for sale to the public; it's obvious that such a claim is entirely out of line. Let's hope that the court recognizes this and does the right thing by tossing the case out of court.

Fortunately, Regenerative Sciences isn't rolling over. They're fighting back, even saying that they welcome the opportunity. Christopher Centeno, M.D., Regenerative Sciences' medical director, says:

"The FDA will finally answer our questions, in court, about their claims and jurisdiction as opposed to doing everything in their power to avoid the issue that we are not a drug manufacturer, but simply a medical practice."

Read their entire press release here: http://bit.ly/dwit5Q

For more insight into this issue, read the article by guest author, Barbara Hanson, Autologous Stem Cells—Hope for the Future (http://bit.ly/b5nEoG). She tells her own story with chronic obstructive pulmonary disease and of the necessity to go outside the country for life-saving stem cell treatment.

== Life or the FDA? ==

Who is the FDA protecting? It obviously isn't the people, and it takes little to see who benefits: Big Pharma.

Regenerative Sciences' willingness to stand up to their bullying is a hopeful event. The FDA's overreaching must be stopped. How many Ciaran Finn-Lynches and Andrew Kents and Barbara Hansons are there in the US? How much longer must they suffer when there's treatment available?

To read the original and see references, go to http://bit.ly/9SFkLZ