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Stem Cell Therapy Clinic Flees to Mexico to Avoid FDA

By February 19, 2013

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Celltex Therapeutics Corporation, the Houston-based stem cell company where Texas governor Rick Perry received treatments for back pain last year, is moving to Mexico to sidestep pressure from the FDA to regulate its procedures.

CellTex is one of several companies that specialize in autologous stem cell injection therapy, where an individual's adult stem cells are isolated (usually from fat tissue), concentrated, and then reinjected to improve a medical condition. The thinking is that the stem cells can promote or speed up healing of injured or deteriorating tissue.

The scientific evidence supporting the efficacy of this stem cell therapy technique is scant, but more central to Celltex's recent business decision is that that the treatments are not FDA approved. Celltex was operating under the premise that, since the treatments involve reinjecting the patient's own minimally manipulated stem cells without additives, FDA oversight was not required. The FDA disagreed, however, and provided Celltex with a formal notice of its position in September 2012.

While Celltex responded to the FDA, it seems that, rather than battle the agency, it has decided to move the stem cell therapy portion of its business to Mexico. It will then be under the jurisdiction of Mexico's Federal Commission for the Protection against Sanitary Risk (COFEPRIS).

You can read Celltex's letter to its customers regarding the move on the Knoepfler Lab website, and find more information about Celltex's move and autologous stem cell therapy at the Genetic Literacy Project. Also, for more background on stem cells, see Delivering on Stem Cell Therapy Treatments, on this website.

Comments

March 10, 2013 at 2:40 pm
(1) SammyJo Wilkinson says:

Paul, since you are quoting Paul Knoeplfer in your article, you might want to take a look at his conflicts of interest, when it comes to his negative opinions on adult stem cells. Also, the evidence for safety is not scant, see our report How Safe Are Stem Cells at http://www.patientsforstemcells.org/how-safe-are-stem-cells/

I was treated in the Celltex trial, along with 233 other people in 2012 before the FDA overreached its authority and stopped the IRB monitored trial. I’ve had fantastic recovery form progressive MS, which is supposed to be impossible. Americans are being duped out of an incredible resource for healing – their own stem cells.

March 12, 2013 at 6:18 am
(2) Biotech Guide says:

SammyJo, thank you for your comments and I am glad to hear of your recovery. Let me just clarify a couple of points you bring up:

(1) I did not quote Paul Knoeplfer in the article. I referred to a page on his blog where he printed the letter actual Celltex provided to its customers in regards to moving its facility to Mexico. I used that link because it was the only announcement directly from Celltex that I could find regarding the move. I did not find any information about it on the Celltex website or in a Celltex press release.

(2) I said the scientific evidence for the procedure’s efficacy is scant. I didn’t comment on the safety.

March 10, 2013 at 3:35 pm
(3) Barbara says:

Paul – I truly wish you and other reporters would start vetting your sources. You ask readers to read more on Paul Knoepfler’s blog without bothering to mention that he is a researcher getting large grants for research on iPS stem cells.

You also provide a link to the Genetic Literacy Project. On that site, there is no mention that George Daley owns several patents dealing with embryonic stem cells. They could become worthless if patients getting treated with their own stem cells by doctors prove to give patients the quality of life and cures they are seeking. This same site mentions a woman who had a face lift and got bone shards in her eye. I would say this is definitely not an adverse effect on the part of the stem cells, but more likely medical malpractice on the part of the surgeon. When stem cells are placed in an environment that calls for bone formation – they form bone. There is no evidence this was caused by the stem cells and yet this story is being circulated far and wide by those who simply have reason to want patients to believe treatment with their own stem cells is risky. In fact, there is evidence as Sammy Jo Wilkinson mentions to indicate quite the opposite.

The only ones without a conflict of interest are patients. There are billions of dollars at stake for researchers, Big Pharma, FDA, and others who will not profit if sick people are successfully treated with their own stem cells by a competent physician.

You do a disservice to readers by not vetting sources and taking the time to present other points of view. Simply providing links to other non vetted stories, is not what good reporting is about. I hope you will take the time to do another story about this issue that is well researched and more factual.

March 12, 2013 at 6:39 am
(4) Biotech Guide says:

Thank you for your comments Barbara. I do try to look at my sources pretty carefully. Generally, I don’t see the conflict you mention between research on embryonic stem cells, iPS cells, and adult stem cells. At the moment, there is too much unknown about all of them. You might be interested in the article I posted a few months ago, Experts Assess the Current Status of Stem Cell Research.

With regard to the story of the woman who had implanted stem cells differentiate into bone shards in her eye lids, the details were described in Scientific American at the end of last year. The Genetic Literacy article, just links to this story, as well as an article from Reuters that discusses a string of serious problems health problems that occurred with individuals receiving unregulated stem cell therapy from providers around the globe.

March 10, 2013 at 5:51 pm
(5) Marie says:

To make expand on another writer’s point –the face lift doctor injected the stem cells into the lady’s eyelid along with a common filler called calcium apatite.

In the lab when you put stem cells in a dish and also put cal apatite in the dish the stem cells form bone–because the stem cells take their clues about what to be from local tissue. Injecting cal apatite with stem cells was giving “bone” signals to the stem cells instead of letting them get their signals from the face cells.

this was a ridiculous mistake on the doctor’s part, and he will have to answer for it. You can also bet the makers of cal apatite filler will add a caution to their label now saying never to inject along with stem cells. That’s how things like that get on labels.

By the way, the FDA allows stem cells if they are processed in one day-these allowed cells would have done the same thing if they had been injected with cal apatite. it wasn’t about the stem cells or about the way they were processed before they went into the syringe.

This story has been repeated everywhere by bloggers with conflicts of interest who actively work to suppress autologous stem cell access.

It’s kind of like someone went in for a lasic eye surgery and the doctor goofed up and made the eyesight worse and now the people who sell eyeglasses are everywhere repeating the story about the botched operation as they insist eyeglasses are the only safe choice.

unfortunately no one ever notices that the people propagating the bones in the eyelid story without sharing the real details are equally conflicted.

March 10, 2013 at 6:10 pm
(6) Jennifer Ziegler says:

Thank you for your article Paul. Like SammyJo I am also a CellTex MS patient cutoff mid treatment. I received one treatment of 200mil. cells, but was supposed to receive 2 more treatments with a total of 600mil cells. As patients, we believe, along with our CellTex doctors that this should be a medical procedure between one intelligent and consenting patient, and my personal skilled physician. We don’t believe our cells should have ever been labeled a bio drug in the first place. You should check Dr. Tommy Curry, PhD of Texas A&M who believes the exact opposite of Mr. Paul Knoepfler. Many in the research community have the same view as the patients, that this is an FDA over reach. I along with many other CellTex patients are thankful that we will still have access to our cells in Mexico.

March 12, 2013 at 7:11 am
(7) Biotech Guide says:

Thanks for the comment Jennifer and I am sorry to hear the FDA action has interrupted your treatments with Celltex.

I looked up Dr. Tommy Curry who is a biomedical ethicist with an interest in regenerative medicine. His area of expertise and focus seems very different than Dr. Knoepfler’s.

There are two different issues: One concerns the scientific basis for assessing the safety and efficacy of autologous stem cell therapy, the other concerns the roles and limits of government regulation in ensuring that the medical treatment individual’s receive is safe and effective. Dr. Knoepfler’s comments focus mainly on the former while Dr. Curry seems to address the latter issue. If someone said they don’t believe autologous stem cell therapy works but they don’t believe the FDA should be able to stop people that want to pay for it from receiving it, wouldn’t they mostly agree with both Dr. Knoepfler and Dr. Curry?

March 10, 2013 at 10:43 pm
(8) Shannon says:

I was a Celltex client until the FDA stepped in and exerted their control. I am a nurse, well educated and INFORMED.

In Western medicine we are taught that we need clinical trials. Truth is, many of us do not have time to wait. Safety has been more than established with adult cells.

As many with MS know, there is no cure. Any medications only prolong the disability, and those meds only have a 30% chance of “working”. The side effects of these FDA approved meds are horrific, to include death.

My own cells should have never been considered a drug. They are MY own natural healers.

March 11, 2013 at 11:58 am
(9) Tom Shepherd says:

Paul,
I recently returned from a clinic in Florida where I was treated for my MS with my own cells. The difference here was that it was a same-day treatment and not frozen and expanded like what Celltex does. Also my stem cells at the Florida clinic are not all mesenchymal stem cells and they are mixed with platelet rich plasma. Additionally, Celltex is a bank and your frozen cells may be retrieved at any time for treatment of a number of medical conditions. There is no cell banking in Florida. Both of these treatments are superior to the effects of MS drugs I had been taking for the last 10 years. The FDA’s mandate is to regulate drugs manufacturered outside the body and not those produced from within.
This whole controversy is a crock, a turf war and a disgrace to the medical research world.

March 12, 2013 at 7:46 am
(10) Biotech Guide says:

Thanks for the comment Tom. I hope the treatment works for you.

I think your point about the role of the FDA is the most central to this situation. The scientific standards for proving safe and effective treatment are pretty established. Trying to say the treatment meets them, when it obviously doesn’t, just distorts the real issue.

Isn’t the question really, to what degree should the FDA be able to regulate this treatment which basically just involves re-injection of one’s own cells? You (and, it seems, all the other commenters so far) have a definite opinion that the FDA is overstepping it bounds, but you are the only one that suggests what the limit should be. Basically, you’re saying the FDA should only regulate medical treatments when it requires using something made outside the body. I don’t necessarily agree. However, it does seem this treatment falls into sort of a gray zone. It seemed Celltex was going to try to make the case that their treatments are outside the line, but this move to Mexico seems to signal a change of strategy.

March 27, 2013 at 8:17 pm
(11) Doug Atkins says:

Paul. I think that the FDA was, by an act of Congress, not supposed to interfere in the practice of medicine. Should that not be their limit? You say you do not necessarily agree that the FDA should only regulate medical treatments when it requires using something made outside the body. So you want more regulation on the part of the FDA when it comes to using a person’s own body parts? More regulation into the practice of medicine? I thought that the practice of medicine was already regulated by state medical boards and others. It’s probably not a perfect system, but no system is. I do not see that the problems regarding FDA bureaucracy are solved by adding even more layers to that bureaucracy.The FDA already complains about not having enough funding to do their current job.

March 28, 2013 at 4:50 pm
(12) Biotech Guide says:

Thanks for your comments Doug. Actually, I have not suggested there should any changes in the level of FDA regulation. The FDA’s role is described in its mission statement. The Center for Biologics Evaluation and Research (CBER) division of the FDA contacted Celltex and outlined in detail why it believes Celltex’s activities fall within its regulatory domain. There is no reason to posit any hypothetical expansion of the FDA’s regulation. The question is whether the FDA is right that Celltex’s activities fall within its current regulatory scope and Celltex is not meeting the defined guidelines. While there may be a good rationale for excepting Celltex’s process, it doesn’t seem to me like it’s enough to simply say it is beyond FDA regulation just because it uses an individual’s own cells.
— Paul

April 1, 2013 at 6:14 pm
(13) Doug Atkins says:

Thank you for the Reply, Paul. In fact I do believe that there is a reason to posit a “hypothetical” expansion of the FDA’s regulation. And, really it is not so hypothetical at all precisely because the FDA has already done this for them-selves. Specifically, in 2006 the FDA changed the wording in its long standing regulation (21 CFR 1271) regarding the use of human tissues “into another person” with the wording “into a human”. They did so without comment from either congress or the public. This simple word change unilaterally expanded their regulatory overview of allogeneic (essentially other) cellular therapies to now also include autologous (essentially self) stem cell therapies. The FDA probably had the power to do this. I’m just not certain that they ever truly had the right.
At this moment Regenexx (a U.S. clinical practice that utilizes human autologous stem cells) is involved in a very expensive lawsuit against the FDA. Regenexx has lost twice in lower district courts supposedly without mention of this regulatory language change on the part of the FDA in either trial. Perhaps the next court case between Regenexx and the FDA will include this detail, because it is not so minor or hypothetical after all.
Thank you for the link to the FDA’s Mission Statement. However mission statements are usually written in a very broad context. And as they say, “The Devil is in the Details.” The details here to me involve obviously, the FDA’s specific CFR or Code of Federal Regulations ( 21 CFR 1271) and their fairly apparent unilateral change of that regulatory language in 2006. Again, the FDA did this without input from either the public or the congress that is supposed to represent us.

June 29, 2013 at 1:02 am
(14) Lbeth says:

The FDA CFR 1271… These facilities are not manufacturing anything … the code is not enforceable.
TITLE 21–…
PART 1271 — HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTSSubpart A–General ProvisionsSec. 1271.1 What are the purpose and scope of this part?
(a)Purpose. The purpose of this part, in conjunction with 207.20(f), 210.1(c), 210.2, 807.20(d), and 820.1(a) of this chapter, is to create a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P’s) and to establish donor-eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/P’s.(b)Scope. (1) If you are an establishment that manufactures HCT/P’s that are regulated solely under the authority of section 361 of the Public Health Service Act (the PHS Act), this part requires you to register and list your HCT/P’s with the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research and to comply with the other requirements contained in this part, whether or not the HCT/P enters into interstate commerce. Those HCT/P’s that are regulated solely under the authority of section 361 of the PHS Act are described in 1271.10.
(2) If you are an establishment that manufactures HCT/P’s that are regulated as drugs, devices and/or biological products under section 351 of the PHS Act and/or the Federal Food, Drug, and Cosmetic Act, 207.20(f) and 807.20(d) of this chapter require you to register and list your HCT/P’s following the procedures in subpart B of this part. Sections 210.1(c), 210.2, 211.1(b), and 820.1(a) of this chapter require you to comply with the donor-eligibility procedures in subpart C of this part and the current good tissue practice procedures in subpart D of this part, in addition to all other applicable regulations.

June 29, 2013 at 1:13 am
(15) Lbeth says:

The FDA CR 1271 mentions the purpose ..The purpose of this part, in conjunction with 207.20(f), 210.1(c), 210.2, 807.20(d), and 820.1(a) of this chapter, is to create a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P’s) and to establish donor-eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/P’s….
The establishments they are feasting on are not manufacturing anything. The FDA legs they are trying to turn into wings are not going to fly. It is not in their progressive DepartmentalNecroticAssociation’s gastrostrangulation entitlements.

July 29, 2013 at 6:24 pm
(16) Craig says:

American Health Industry makes $80 to $100k of a knee replacement.

Why would they allow stem cell to make progress here in America?

It will cut into their bottom line. So the corporate owned fascist FDA will not allow any type of real stem cell progress here.

F American health care. Go to Mexico where you (as a doctor) can provide a real service to humanity.

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