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Texas stem-cell provider under FDA gun

Last September, Nature predicted a stem-cell showdown in Texas, between the US Food and Drug Administration (FDA) and a company providing unproven stem-cell treatments, and that seems to be happening.

In a severe “warning letter” posted on the agency’s website this week (but dated 24 September 2012), the FDA told Celltex Therapeutics of Sugar Land, Texas, that its stem-cell products fall under FDA regulation and need to be approved before use in patients. The company lacks such approval but has been providing them to physicians who then inject them to paying patients for pricey, unproven clinical treatments.

The FDA’s reasoning is that Celltex stem-cell preparations constitute drugs and do not meet the exemption requirements that would allow such cellular products to be used at the discretion of doctors. The FDA argues that the cells are more than “minimally manipulated” because the “processing … alters the original relevant characteristics of the adipose tissue” from which the cells were derived. The warning letter also states that injection of the cells does not meet the exemption requirement that they be applied for “homologous” use. (Although the explanation in the document is redacted, this is presumably because cells,  originally part of adipose or fat tissue, are being injected for treatment of neurological and other non-homologous uses.)

Altogether the letter points to 29 “significant objectionable conditions”  with Celltex’ operations, including the failure to ensure that procedures for guaranteeing safe and quality cells are being followed. The letter points out that Celltex has failed, in response to a previous chiding about quality-control procedures,  to “provide sufficient detail to fully assess the adequacy of your corrective actions”.

The letter is a challenge to new regulations that the Texas Medical Board put in place in April, which had made FDA approval an option, not a requirement. Those regulations state that doctors injecting stem cells into patients need FDA approval or the approval of a local institutional review board (IRB). The warning letter makes clear that the FDA expects its approval to be mandatory — effectively replacing the “or” with an “and”.

The FDA, which also oversees IRBs, likewise blasted the Houston-based Texas Applied Biotechnology Research Review Committee (TABS RRC) IRB that approved a clinical study by Celltex. The FDA found that the IRB “significantly violated applicable federal regulations governing the operation and responsibilities governing the operation and responsibilities of IRBs”. The five faults detailed by the agency include a conflict of interest of two IRB members who had helped Celltex draft the study’s protocols and the failure to ensure that Celltex protocols met safety regulations designed to protect children. The FDA’s 24 September warning letter to TABS RRC says, “we have no assurance that the IRB procedures are adequately protecting the rights and welfare of the human subjects of research”. The warning letter forbids TABS RRC from enrolling any new subjects in studies until the “FDA has evidence of adequate corrective actions”.

FDA warning letters have teeth. Celltex had 15 days to detail steps taken to correct the various violations or risk “regulatory action without further notice” which could include “seizure and/or injunction”.

So what’s next for Celltex? According to an exchange that Paul Knoepfler had with Celltex, they are still in business.

On 1 October, a week after receiving the warning letter, Celltex attempted to defuse the news by announcing that it had received “a letter” (although Cellex didn’t reveal at that time that it was the relatively harsh “warning letter”). Noting disagreement with the FDA’s ruling that its processed cells need to be regulated as drugs, the company announced a “new clinical program” through which it planned to work with the FDA.

So perhaps within 15 days of 24 September, the company posted a letter that appeased the FDA. Even if it hadn’t, and the FDA has decided on some form of enforcement, we will not know until the agency makes its move.

Celltex could try to argue in court that the FDA does not have jurisdiction over unproven stem-cell treatments. But that has been tried, by Broomfield, Colorado-based Regenerative Sciences. That case upheld the FDA’s authority.

With Governor Rick Perry a big fan of stem-cell treatments — and the first publicized case of someone getting treatment there — there has been some speculation that he would stand up for Celltex.

But according to a spokeswoman for Perry, the governor says the matter is “between Celltex and the FDA“.


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    I was diagnosed in 2010 with multiple sclerosis (MS). Prior to my diagnosis I was a nurse and active member of society. For the last two years I have not been able to walk, write, drive, speak clearly or feel with my hands. I also deal with constant fatigue and cannot think clearly.

    My husband is an acive duty soldier in the US Army. He has had to take on all the responsibilies, including the care of our daughters.

    I have tried the various FDA MS approved therapies recommended by my neurologist and have failed each one. The following are the therapies I have tried and thier possible side effects:

    1)Tysarbi-There have been 14 new PML cases, bringing the total to 285. Of the 14 cases, 5 are in the US. The location for the others is unknown. There have been 3 more deaths, and the total is now 62 (still at 22%).

    2) IV Steroids- Can cause diabetes and early osteoporosis.

    3) Rebif-I lost 30 pounds in two months, flu-like symptoms, hairloss. A recent study came out that interferons DO NOT slow progression of disability.

    4) Plasmaphoresis- can cause blood clots and exposure to Hepatitis B.

    The MS has caused cerebellar ataxia. This causes me to have uncontrollable tremors, speech difficulty and balance issues. Nothing can be done for this except regenerative medicine.

    I had my adipose tissue removed in September in Houston TX. A company by the name of Celltex grows a persons own adult mesechymal stem cells (MSC) from the adipose tissue that is extracted. MSC’s have been shown to repair and regenerate the damage to tissues that several diseases can cause.

    The FDA stopped all IRB trials through Celltex under the premise that a persons own stem cells are a drug, even though I had already begun the process. I am an educated patient, and there is hardly any risk in my own adult stem cells.

    The FDA’s interference of these IRB infusions have left me and my family feeling hopeless. I was wanting to receive this treatment in the US, but the FDA is forcing American citizen’s to be medical tourists in other countries.

    I have applied to several clinical studies, but never qualified. My heart cannot handle the chemo that Northwestern uses, and the Cleveland Clinic requires optic neuritis and the patient be ambulatory.

    What would you do if this was you or a loved one?

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