When it comes to regulation of stem cells and its therapeutic use, there is a comprehensive interpretation what is legally conceivable and what is not permissible. First viewpoint is the ethical concern from where stem cells are reaped. The use of embryonic stem cells occasioned in enormous debates about cloning humans and potentially abolishing emerging life for research purpose and had been barred subsequently by a lot of nations. The second viewpoint is the protection of customers as there was an initial movement that stem cells could heal everything without any proof. Prove in this context is the proof via clinical trial that the drug is safe and has an affirmative effect on a human being for any specific condition. Regulators in a lot of states, therefore, professed all stem cells as drugs and imposed that treatment with stem cells has to be approved by regulators before given to patients. This notion is valid for heavily manipulated products, but when it comes to treatments with own stem cells, i.e. autologous stem cells, regulators inferred this in their own way in line with prevailing regulations. Since the introduction of stem cells as drugs a decade ago, principally, only a handful of highly manipulated stem cell drugs had been approved by the FDA and EMA. Price for such approved medicines is reaching 1.2 million Euros per treatment, occasioning in that most of them had been used only a couple of times for patients. Insurance firms however reviewed every single case because of the very costly treatment price. As mentioned before, there are two passageways to develop new medicinal merchandises for patients, one is the clinical trial passageway for industrialized produced products intended to be sold at the mass-market to treat a particular symptom, and the other passageway is the medical process passageway. The pathway used by the industry is, unquestionably, more complex, takes much more time as it is using mostly allogeneic stem cells and often heavily manipulated gene technology or a blend with certain molecules which might trigger certain effects on the cellular structure of a body. It is a complex process but has helped millions of patients particularly in the 19th and 20th century to improve quality of life. The medical process pathway is an established pathway to help patients with unmet medical prerequisites too and is based on observation of individual patients and the trial to develop a therapy with newest scientific know-how to improve the condition of a single patient. This methodology is often used when mainstream medical way could not improve the conditions in such an individual case. This treatment is personalized and as per many nations can be implemented by a doctor even as an unproven process in case the physician believes the procedure could aid the patient in improving quality of life and lessen pain. This treatment is personalized and as per lots of nations can be implemented by a doctor even as an unproven process in case the physician believes the process could help the patient in improving quality of life and decrease pain. There is, however, a sturdy foyer against this activity as this treatment besides being categorically personalized, is not following the costly clinical trial path, to get approval to use a new medicine for humans. The argument that autologous (OWN) stem cells are not a drug when used after concentration at the same individual, as it is only improving and supporting the natural regeneration process, is not accepted by some regulators in this global medical situation. Moreover, regulators claim that those treatments are unproven for particular claims and thus need to follow when used the clinical trial path. It seems that this activity is more a political subject than an issue to help patients with early new technological expertise and approaches and has divided regulators and medical supporters all over the world. Very often it is however overlooked that such early medical treatment is permissible by essentially all nations even the US and EU although the regulations are not well known by the public and inferred in a way stating that no stem cell treatment is authorized if not explicitly approved by experts! As a side-effect of this understanding, there are only some approved, new treatment approaches available in Western regulated nations, while other nations have adopted new science-driven technologies even though some of those methods are still in their early investigation state. In respect of regulation, we like to review the basis of stem cell treatment interpretation of the mostly discussed nations and try to clarify what is legally conceivable.
As per the FDA, all stem cells are drugs and any treatment has to be reviewed and approved before being used in human beings. At the same time exist in the CFR 21 -1271 in the HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Regulation the paragraph 15b. stipulating besides others: “You are not required to conform with the requirements of this part if you are an establishment that removes HCT/P’s from an individual and implants such HCT/P’s into the same person during the same surgical process.”
In the EU
According to EMA, all stem cells are considered as drugs and any treatment has to be reread and approved before being used in humans. At the same time occurs in paragraph (8) of the statement in DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, that:(8) Tissues and cells used as an autologous graft (tissues taken out and transplanted back to the same person), within the same surgical process and without being imperiled to any banking process, are also omitted from this Directive. The quality and safety considerations related with this process are completely different. From patients advocate point of view both FDA and EMA are exercising an interpretation which has resulted in a very high confusion in this new science-related medical treatment which causes uncertainty, although there are millions of patients already globally treated with own or expanded cord blood tissue-derived stem cells with quite good success and now serious advert events. FDA and EMA are arguing about a few cases which had been registered as adverse event for stem cell treatments not recognizing that according to their own statistic about 200 000 people die, in the USA alone, due to approved drug side effects. Moreover, in the EMA regulation “Directive 2001/83/EC” it is openly defined that: “The scope of this Regulation should be to regulate advanced therapy medicinal products (ATMPs) which are envisioned to be placed on the market in the Member States and either prepared industrially or manufactured by a technique involving an industrial process.” Those industrialized produced ATMPs have to follow the current drug regulation, i.e., it necessitates a pre-marketing approval.” A medical process with or without the approval of an Ethical Committee in Europe or the Institutional Reviewing Board, in the US, has nothing to do with ” being prepared industrially or manufactured by a technique involving an industrial process nor are intended to be placed on the market in the Member States” it is a personalized activity for a singular medical situation. The Declaration of Geneva of the World Medical Association (WMA), accentuates and binds the doctor with the words, “The health of my patient will be my first thoughtfulness,” and the International Code of Medical Ethics declares that “A doctor shall act in the patient’s best interest when offering medical care.” Also, the World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical philosophies for medical research encompassing human subjects, including research on identifiable human material and data. This declaration in its paragraph 37, stipulates: Additionally, the World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research encompassing human subjects, including research on identifiable human material and data.
Unverified Interventions in Clinical Practice
In the treatment of an individual patient, where confirmed interventions do not exist, or other known interventions have been futile, the doctor, after seeking expert guidance, with cognizant consent from the patient or a legally authorized representative, might use an unverified intervention if in the doctor’s judgment it offers hope of saving life, reinventing health or assuaging suffering. This intervention should consequently be made the object of research, designed to assess its safety and efficiency. In all circumstances, new information must be recorded and, where suitable, made publicly accessible. In the US there are about 350 clinics offering stem cell treatment compliant with FDA regulation 1271 15b as a medical process while in Europe only some have used the new treatment method, replicating the treatment potential of stem cells in line with the Declaration of Helsinki. Many nations outside the US and EU, having regulated adult stem cell treatments as a medical process, are also supporting those patients who cannot be treated effortlessly in their own motherlands because of negative regulatory interpretation. This situation has ensued in medical tourism to satiate medical prerequisites of patients, considered by FDA and EU regulated nations as an exploitation of the illiterate patients, where hope and profit come before scientific evidence. This is surely an unfair and a not justified statement as many clinics providing this treatment service have standards, not only matching but at times even out path established Western standards and treat surely already very well-educated and knowledgeable patients. Additionally, stem cell clinics all over the globe are using chiefly so-called adult stem cells reaped from a patient’s own bone marrow, adipose tissue. These are autologous (own) stem cells. Some clinics have developed proficiency to use expanded mesenchymal stem cells from umbilical cords. Those stem cells are allogeneic (3rd party) stem cells and have as they are stretched a higher quantity of stem cells, significant for therapeutic use in the arena of regeneration. These stem cell treatments have nothing in common with the highly manipulated and industrialized manufactured stem cell products. There are, however, thousands of circumstantial reviews and studies all over the world displaying that the use of own stem cell and minimally expanded (Passage 4 to 6) mesenchymal stem cells from Umbilical cord tissues (Wharton Jelly) have not triggered serious side-effects, but improved quality of life of several people treated. What is documented in numerous studies and testimonials is that adult stem cell treatment is well endured, with next to no side-effects and has helped in many individual cases to mend the quality of life. We confess that this are individual cases and as stem cell clinics offer a personalized treatment with own stem cells the outcome can differ, except that essentially no serious side-effects had been reported so far besides the very few politically exploited circumstances in sensational news reports. Viezec is cooperating with highly competent clinics in nations where stem cell treatment is allowable and where many optimistic outcomes helped patients to improve their health conditions.
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