Regulations………

Regulators, Legislators Taking Action on Unproven Stem Cell “Treatments”

December 2017 by ISSCR – International Society for Stem Cell Research

Below there is a published statement by ISSCR explaining the legal viewpoint of stem cell treatments, which we as patient advocates believe is a very much one-sided viewpoint favoring the clinical trial path ONLY. Considering this part of FDA regulation, developing a drug for the mass market, it is correct, those stem cell treatments are not FDA approved, but we are not talking about a drug treatment we talk about a medical procedure for individual medical cases being outside the regulated mass-produced drug market.

To bring new medical treatments & products to the market and help patients with unmet medical needs, we have two pathways. Industrialized produced products for the mass market versus individualized treatments as a medical procedure in a Point of Care setting. Both paths have been successfully developed and introduced products and technology to the market.

The well-established, but much slower drug/pharmaceutical pathway did benefit primarily in the late 19th and early 20th century millions of peoples with the discovery of vaccines, immunosuppressants, NSAID´s, statins to mention a few.

The physician’s pathway already existed in early time, well demonstrated with Hippocrates, around 300 BC, considered the father of medicine. This path especially in the 20th century, paved the way to open heart surgery and IVF, opening up entirely new avenues of medical treatments, which continues on an accelerated path in this early 21st century with cellular and stem cell treatments.

Both pathways have their place in the medical treatment field, while one, the drug-related, is developing therapies in the slow and robust aircraft carrier model, while physicians have a more speedboat mentality as shown in the graph beside. The physician’s pathway is faster because it is different. It starts with observing and discussing individual cases, doing early investigational treatments with individuals, resulting in anecdotal confirmation of safety and efficacy, without using randomized, placebo structured clinical trials. This treatment therapy targets a singular person and is truly personalized. There is no claim that one is better than the other, it’s just different, and a physician also has to invest in an adequate infrastructure to provide the Point of Care treatment.

The information provided by ISSCR is therefore from our point of view rather a political statement regarding existing regulation supporting the drug market model, without recognizing the important pathway for patients as a medical procedure with unproven drug (= stem cell) treatments.

The TEXT published on the net by ISSRC:

The scientific and clinical communities have long been troubled by clinics operating around the world that market unproven stem cell “treatments” directly to patients.

It is particularly distressing that people often go to these clinics for relief or a cure for an intractable disease or injury, and can end up paying thousands of dollars for products that are not approved for use as advertised, have not been scientifically tested to know if they work, and can put their health in jeopardy. This includes procedures using the patients’ own stem cells (aka autologous use), which can also carry with it tremendous risk, even death.

Fortunately, several jurisdictions around the world are beginning to pay attention to the activities of such clinics. Efforts are underway to hopefully stop clinics from peddling risky stem cell treatments, and help patients by providing clear information about whether advertised stem cell products are safe and proven to work.

Regulatory Efforts in the U.S.

Recently, the U.S. Food and Drug Administration (FDA) announced enforcement actions against two clinics: it seized unapproved products from StemImmune Inc. of San Diego, California, and issued a warning letter to the U.S. Stem Cell Clinic of Sunrise, Florida. Both were providing “unapproved and potentially dangerous” stem cell interventions that put patients at risk. In the announcement, the FDA commissioner stated that the agency “will take a firm stance against those that prey on the medical promise of regenerative cell therapies to market treatments potentially unsafe or unproven so-called cures.”

The FDA also recently announced new regulatory and enforcement measures meant to more clearly define stem cell treatments that require agency oversight. The ISSCR, which has long advocated for such a move, issued a statement of support, noting that the agency will need additional resources to enforce the new rules effectively for the protection of patients.

Outside the U.S.

In Australia, the government announced it too will change regulations regarding the use of autologous stem cell interventions—those that are removed from a patient and then re-applied to that same patient. While those treatments had not previously been regulated, they are now brought into the regulatory regime, thanks in part to news reports

India also appears to be tightening up oversight of stem cell-based interventions, with the release of National Guidelines for Stem Cell Research that comes down strongly against unproven uses of stem cells. They admonish that “…every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice.”

New Legislation in California

These activities have not been limited to national regulatory agencies. A law passed in California in October requires clinics to inform patients if they are using stem cell interventions that have not been approved by the FDA. Clinics will be required to post a notice in their office and provide handouts to each patient, stating that the procedure has not been approved for clinical use.

Ensuring Stem Cell Products are Safe

As potential therapies are developed in the lab, and then made into products for medical use, they require careful review and testing to ensure they are safe AND effective.

This Closer Look at Stem Cells site includes accurate, scientifically vetted information about the potential of stem cell medicine and its current limitations. If you or a loved one is considering a stem cell treatment, review the ‘Stem Cells & Medicine’ section to learn more about what is known, and how to approach your physician with questions, before moving forward with any stem cell procedures.

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