Clinical studies are applied in the pharmaceutical industry, to specifically determine the action and evolution of the product and its final behavior in the body through pharmacokinetics and pharmacodynamics using a process where up to 4 phases of the drug are commonly involved with the end goal to develop a protocol and measure different interactions.
Biological products such as cell therapies have some characteristics compared to small molecule drugs. These products require novel study designs to address their uniqueness. Close attention to detail must be paid when defining critical endpoints. Special monitoring and reporting should also be considered due to the safety issues associated with these products, especially long-term monitoring, because cell therapies are even more complex and difficult to apply compared to conventional clinical studies as a consequence of the nature of the product. However, we must consider the importance that these therapies have contributed in the last 25 years, especially in revitalizing regenerative medicine, providing significant improvements in the quality of life of patients who have undergone these treatments for various causes and diseases. The mode of action is not always perfect, and the potency tests are still imprecise, hence the main concern when reviewing any clinical trial on allogeneic transplantation in autologous or donor cell therapies and also those of animal origin Xenotransplantation is that they all enjoy 100% biosecurity and with minimal risk of immune rejection.
The aforementioned does not relate to Biocell Ultravital products since they use peptides and cell extracts in their formulas that guarantee 100% safety without the possibility of immune rejection in patients. We have accumulated for more than 70 years of varied clinical expertise through specialized doctors mainly in Europe who have used Cellular Renovation Therapies for more than 3 generations to establish safety and efficacy parameters, mainly on patients for which an adequate evaluation is required to determine various aspects. Such as, their medical history, their family history, risks environmental conditions, and predisposition to degenerative diseases. In all the above parameters such as to time and dose to be applied are crucial be able to determine the therapeutic effectiveness. This is determined according to the type of trial or clinical expertise used to develop the application protocols focusing on the type of pathology. As of 2017 we had carried out 1,292 new observational tests in which the following criteria were evaluated:
La terapia de H Citoplacell 4G funciona de forma natural para inducir al cuerpo a reestructurar sus mecanismos endocrinos regulando las funciones de las células solubles en agua o solubles en grasa, involucradas en el equilibrio hormonal. Actúa en ambos casos a través de diferentes transportadores de proteínas y mediante la empatía con las células. Su acción como estimulante celular ejerce eficacia en función de sus potentes componentes antioxidantes para la activación de los ciclos y su estructura en las células.
El Envejecimiento Organico y las Terapias de Renovacion Celular
Antioxidante Celular.
La vejez es principalmente un proceso de oxidación celular natural y progresiva, pero este mecanismo puede ralentizarse con medicamentos antioxidantes efectivos, que minimizan sus efectos y mitigan los estragos del envejecimiento orgánico y físico para prolongar la esperanza de vida de cada individuo.
El oxígeno que utilizamos para respirar es uno de los principales componentes responsables de la oxidación celular y sirve para producir energía en todo el cuerpo, pero pequeñas porciones de este elemento producen radicales libres, que se forman normalmente en el cuerpo durante el metabolismo. La poderosa acción de H Citoplacell 4G logra un efecto terapéutico además del endocrino. Proporciona una alta protección antioxidante, con un aumento en la energía celular, y los componentes de su fórmula estimulan la función de la hipófisis para mejorar la producción de la Hormona del Crecimiento Humano (HGH), que disminuye con la edad y el estrés. Entre otros beneficios, la HGH se conoce como la hormona de la juventud.
¿Qué es H Citoplacell 4G?
Es un tratamiento 100% natural de calidad farmacéutica que no contiene hormonas sintéticas, pero sí componentes auténticos precursores hormonales, por lo que su indicación es altamente efectiva como terapia coadyuvante en las funciones endocrinas, además de su poderosa actividad como antioxidante celular.
¿Cómo funciona?
Funciona a través de extractos celulares y potentes antioxidantes de 4ª generación. La sinergia de aminoácidos y péptidos catalizadores en H Citoplacell 4G estimula la glándula pituitaria para producir más HGH, la hormona del crecimiento humano, mejor conocida como la "hormona de la juventud". También promueve la producción de testosterona o estrógenos, dependiendo del sexo del paciente.
¿Qué beneficios proporciona H Citoplacell 4G?
- Excelente antioxidante para una función celular óptima.
- Aumenta la síntesis de proteínas en casi todas las células del cuerpo.
- Aumenta la movilización de ácidos grasos de los tejidos adiposos para obtener energía.
- Aumenta la producción de testosterona en hombres y estrógenos en mujeres debido a su contenido de DHEA y pregnenolona.
- Promueve el desarrollo de masa muscular, aumenta la fuerza, la resistencia y contribuye a un cuerpo más esbelto.
- Mejora significativamente las funciones cognitivas y el estado de ánimo.
- Antioxidante celular.
- Propiedades cardio-protectoras de sus componentes de coenzima Q-10.
¿Cómo debo tomar H Citoplacell 4G?
Como tratamiento preventivo para personas sanas, se recomienda una (1) cápsula por la mañana y una (1) cápsula por la noche diariamente durante seis meses continuos o intercalados. Para personas con alguna afección o enfermedad indicada aquí, se recomienda consumir dos (2) cápsulas por la mañana y dos (2) cápsulas por la noche diariamente durante doce (12) meses como complemento de los medicamentos indicados por el médico tratante.
Nota:
La dosis puede aumentarse según el cuadro clínico del paciente y el criterio del médico; los resultados dependen de completar el tratamiento.
¿Cuáles son los efectos secundarios de H Citoplacell 4G?
Este producto no tiene efectos secundarios ni contraindicaciones con otros medicamentos. Carece de propiedades tóxicas debido a sus componentes orgánicos 100% naturales.
¿Está disponible Citoplacell 4G en las farmacias?
Debido a que es un producto de origen biológico y no farmacéutico, no se vende en farmacias tradicionales, solo en algunas especializadas como:
Biopharmaxie y Schweizer Klinik Biocell.
H Citoplacell
Indicaciones:
- Excelente antioxidante para una función celular óptima.
- Aumento de la síntesis de proteínas en casi todas las células del cuerpo.
- Aumento de la movilización de ácidos grasos desde el tejido adiposo para obtener energía.
- Aumenta la producción de testosterona en hombres y estrógenos en mujeres debido a su contenido de DHEA y pregnenolona.
- Promueve el desarrollo de masa muscular, aumenta la fuerza, la resistencia y contribuye a un cuerpo más delgado.
- Mejora significativamente las funciones cognitivas y el estado de ánimo.
- Antioxidante celular. Propiedades cardio-protectoras de su componente coenzima Q-10.
Composición:
Cajas de 30 cápsulas de 650 mg. / Cajas de 60 cápsulas de 650 mg.
Cada cápsula de 650 mg. contiene:
Extractos opoterapéuticos: Placenta, Glándula Pituitaria, Glándula Suprarrenal.
Extractos de péptidos: Placenta, Glándula Pituitaria, Glándula Suprarrenal.
Otros activos: Superóxido Dismutasa, Glutatión Peroxidasa, Glutatión Reductasa, Glutatión Transferasa, Adenosina Trifosfato (ATP), Ginkgo Biloba, Tecoma Curialis, Coenzima Q10, Jalea Real, Albúmina de soja hidrolizada, DHEA, KH3, Riboflavina, Pregnenolona, Tiamina, Huperzine, Vinpocetina.
Estabilizadores y Excipientes.
Mecanismo de acción de la 4ª generación celular
El mecanismo de acción de los péptidos es similar al de los medicamentos, ya que los tres últimos aminoácidos adyacentes a la región C-terminal de los péptidos con actividad terapéutica están fuertemente unidos al sitio activo donde tienen una mayor especificidad de inhibición. Los bio-péptidos están protegidos en cápsulas con recubrimiento entérico para evitar su degradación en el tracto gastrointestinal y buscar su mejor absorción en las paredes intestinales, beneficiando así el porcentaje de absorción en sangre. Hemos incorporado catalizadores en cada fórmula y tres aminoácidos (arginina, glicina y ácido aspártico) para aumentar la reacción química del cuerpo para el acoplamiento y la absorción posterior. Al incorporar esta secuencia en las diferentes cadenas de péptidos en diferentes posiciones de la fórmula estándar, se permiten nuevas variantes tanto en la cadena lateral de ácido aspártico cargada negativamente como en la arginina (cargada positivamente). La fórmula y los métodos obedecen a una patente exclusiva de los productos de 4ª generación de Biocell Ultravital para mejorar su absorción cuando se administran por vía oral para unirse a la molécula objetivo y restaurar su efecto terapéutico cuando llega a su destino.
Farmacocinética y Farmacodinamia
Los componentes de las diversas fórmulas llegan a las células, ya sea directamente o indirectamente a través de la sangre en el caso de los productos orales, y son incorporados por las células a través de los diferentes medios de transporte celular, dependiendo del tamaño de las células y las moléculas en cuestión. En el caso de moléculas grandes, su incorporación a las células se llevará a cabo mediante endocitosis mediada por receptores, siguiendo la cadena: vesícula, endosoma y lisosoma. En el caso de moléculas más pequeñas, su incorporación se realizará mediante difusión simple o difusión facilitada por proteínas, dependiendo del caso.
Administración:
Uso oral, consumir antes de las comidas para mejorar la absorción, preferiblemente con agua.
Dosificación:
Como tratamiento preventivo para personas sanas, se recomienda una (1) cápsula por la mañana y una (1) por la noche durante seis meses intercalados.
Para personas con alguna condición o enfermedad indicada aquí, se recomienda consumir dos (2) cápsulas por la mañana y dos (2) cápsulas por la noche durante doce (12) meses como refuerzo complementario a los medicamentos indicados por el médico tratante.
Se puede tomar indefinidamente ya que sus componentes no generan depósitos.
Efectos secundarios:
Debido a su contenido de péptidos y opoterapia en su fórmula, en algunos casos podría causar un ligero dolor de cabeza, que desaparece después de unos minutos, las náuseas son muy ocasionales y desaparecen en pocas horas.
Contraindicación.
Se puede combinar de manera segura con otros medicamentos.
En las dosis recomendadas, no se han observado reacciones adversas en ningún caso.
Aquellas personas con diabetes deben ser controladas primero.
Presentación y embalaje:
Contiene una caja con dos (2) blísteres de 15 cápsulas de 650 mg cada una, y su fabricación se lleva a cabo en un ambiente estéril de acuerdo con las regulaciones internacionales de la Farmacopea Europea. No utilizar después de la fecha de caducidad, ni cuando el blíster presente la cápsula rota o el envase de seguridad esté abierto o forzado.
Extracción y obtención de biopeptidos y extractos celulares:
Es importante señalar que las fórmulas contienen componentes biológicos de origen animal en combinación con otros compuestos que mejoran la acción terapéutica y se extraen especialmente en la etapa embrionaria y se procesan durante el segundo mes de gestación. Estos componentes que forman parte de las fórmulas de algunos de nuestros productos se obtienen después de un largo proceso bioquímico y están certificados como libres de priones, pirogenos, bacterias, nanobacterias, hongos, virus, y después de muchos controles, se eliminan al 100% los riesgos de una reacción inmunológica en los seres humanos.
La experiencia clínica de muchos años ha demostrado que los cerdos y las ovejas son los mejores donantes, porque son fuertes y resistentes inmunológicamente. Prueba de ello es que incluso en el siglo XXI, la mayoría de los trasplantes de válvulas cardíacas para los seres humanos se derivan de cerdos, además de que la insulina y muchos productos derivados con fines terapéuticos provienen de estos. Estos métodos se controlan continuamente para determinar que cumplen con los estándares más estrictos requeridos por la bioseguridad para fines terapéuticos. Todos los componentes y otros ingredientes activos de las fórmulas también están aprobados por la Agencia Federal de Alimentos y Medicamentos (FDA) y se fabrican en los EE. UU. por BIOCELL ULTRAVITAL USA bajo licencia suiza de Biocell Ultravital.
Conservación:
Mantener en un lugar seco y fresco a temperatura ambiente entre 5 ° C y 40 ° C. No usar después de la fecha de caducidad, ni cuando el blíster presente la cápsula rota o el envase de seguridad esté abierto o forzado.
Control del producto terminado:
Dos (2) laboratorios independientes realizan varios análisis y controles micóticos, biológicos, bacteriológicos de tipo 5, análisis inmunocelular multicéntrico, pruebas Anti brucelosis, controles virológicos, múltiples pruebas anti-priones, bacteriosis, ciclosporas, micobacterias, salmonelosis de acuerdo con la materia de biología con fines terapéuticos para el consumo humano según las regulaciones actuales de la CE.
Advertencia:
Biocell Ultravital garantiza la pureza y calidad de sus productos y no se hace responsable de los daños a terceros que puedan causar una mala praxis.
How Does it Work?
How the Formulas are Developed?
All our products have been formulated to optimize cell function because if we have healthy cells, we will be healthier every day, and they are based on our 4 pillars of cellular longevity. They work together as a whole to promote energy production and cell growth.
We strive to achieve perfection for each of our therapeutic categories, since they are formulated by carefully selecting each component after confirming its characteristics and clinical trials that positively compromise the efficacy in each formula, this is basically the science on which our products and therapies are based.
Biocell Ultravital products are formulated with ingredients that are 100% natural biological substances, with the highest quality standards, containing cellular extracts of animal origin and peptide hydrolysates extracted from plant extracts and glands of young animals in combination with antioxidants, enzymes and vitamins we managed to optimize the formulas and their therapeutic scope.
All raw material sources are carefully selected from organic plants and organs of pigs and sheep less than one year old and undergo a prion and decontaminated pharmaceutical standardization process that meets high biosecurity standards for reach specific concentrations of high purity and are processed under strict controls to guarantee the high quality and purity of their products.
No chemicals, other harmful or unwanted substances are used in the extraction. Modern technology ensures the recovery of assets in a biologically natural way, without changes. This is very important for the safety of each formula. None of the components in Biocell Ultravital formulas are genetically modified. (NON GMO)
Production and Extraction of Bio Peptides 4th Cellular Generation
The chemical synthesis to produce bioactive peptides of the 4th cell generation of
Biocell Ultravital are obtained using combined methods of enzymatic hydrolysis through proteolytic enzymes and by fermentation using starter cultures. This combination of both methods gives origin to peptides with a safer biological activity due to the fact that in one all the contaminating traces are eliminated and the other facilitates the absorption through the intestinal tract. An additional advantage of enzymatic hydrolysis is the reduction of allergens. The procedure to obtain, isolate and identify biopeptides with specific biological activity, is obtained with the solution of the gland or organ to extract biopeptides, to which papain, pepsin, trypsin are added, the application of different enzymes pursue the formation of a mixture with different ranges of biological activity and incubated for a certain time to obtain the desired degree of hydrolysis.
After this, the hydrolyzate is fractionated by exclusion chromatography and semi-preparative liquid chromatography in reverse phase, selecting the fraction with the highest activity as a result of the first invitro tests, and finally the sequence of the peptides responsible for generating the activity is identified. The desired therapy is obtained by applying mass spectrometry and / or N-terminal sequencing. However, hydrolysates are complex mixtures and can contain up to hundreds of different molecules, therefore, locating bioactive peptides in these procedures is a biochemical work of constant expertise that results in a difficult task and requires a lot of time and dedication. The fractions usually still contain multiple compounds that require additional cycles of fractionation, concentration and evaluation of bioactivity to be able to identify the molecule responsible for the activity in the formulas of each product according to the therapeutic indication.
Consequently, the enzymatic hydrolysis used offers undoubted advantages, such as the absence of substrate degradation processes since the enzymes are selective for a type of bond, pH values between 5 to 10 and the temperatures between 40 to 60ºC, thus maintaining or improving the nutritional value of the protein. The specificity of the enzyme affects the size, quantity, and composition of free peptides and amino acids, as well as their amino acid sequence.
Safety in Therapies
Safety control is a very important factor, especially when it comes to high quality health products, which is why at
Biocell Ultravital in France, which is the main headquarters where all the research and development of the formulas take place, we have monitoring and follow-up mechanisms for each product, this to prevent any error in the next production, that is why we are continuously implementing software for the detection of technical failures of the human team in charge of production. This translates into maximum safety controls that guarantee the complete quality of the production, eliminating 100% possible adverse reactions due to the indication of some of our products that does not correspond to a contraindication already described.
This discipline has become responsible for quality control in the formulation and manufacturing phases thanks to the detection, evaluation, knowledge and analysis for the prevention of adverse reactions and other possible problems related to the products, covering a wide spectrum of continuous analysis so that they do not cause any harm to the patient. We actively participate in decision-making when manufacturing to prevent possible complications in any of the production stages. Thanks to the standardization and development of specific protocols established for each production and subjected to continuous analysis adhering to very specific guidelines we are able to prevent these unwanted complications. We are mandated by compliance with the European Pharmacopoeia in Europe and adhere to current FDA regulations when manufacturing the different products corresponding to Biocell Ultravital Cellular Renovation Therapies.
Research and Development
When
Biocell Ultravital incorporates products with new formulas and they reach the market, at least an average of 5 to 7 years have elapsed, consumed in the different phases of research and development. This journey requires a scientific and economic effort, for this reason we say that out of every 300 new formulas that are beginning to be investigated, only 20 end up becoming treatments available to patients either as an adjunct or preventive of cellular function and the immune system.
Working in the context of formulas based on opotherapeutic extracts or cells of xenogeneic origin, they aim to support the expansion of products for basically strengthening the immune system.
Cellular Renovation Therapy may contribute as reinforcement to the primary treatment to treat the various human diseases that are associated with failures of the immune system. In order to achieve this purpose the continuous efforts of a scientific committee structured by various institutions in the field biology headed by Prof. Dr. Ben L Pfizer is needed. These contributions guide new formulations that improve the components has been allocated to four fundamental guidelines with specific objectives corresponding to the 4th generation cellular products by Biocell Ultravital: Protection, Repair, Revitalization and Regeneration properties. These therapeutic lines are developed with a common research and development strategic plan for each product category.
Manufacturing Plants and Procedures
In Europe, research, production and development is carried out at Biocell Ultravital, France, and we share part of the manufacturing in two other associated plants, mainly for the production of some raw materials, between Germany and the Netherlands.
We also manufacture our products in the USA, BIOCELL ULTRAVITAL USA Laboratories, where we have a modern production factory especially for manufacturing formulas and products for oral presentation.
Since our products formulas require components be extracted from a biological source, in all manufacturing plants we have ensured that they are manufactured in production rooms that have state-of-the-art equipment controlled by software that manages the procedures monitoring each phase of the process. Development with the latest air conditioning, quality and safety systems, to ensure that the final product does not lose its therapeutic potency, for this reason the active ingredients of each formula and the preparation in the initial phase are conditioned in isolated clean rooms and by specialized professionals trained to measure and control the production process from the moment this first manufacturing phase begins and continuing these quality controls through each phase of production until the final product is approved.
Each manufacturing plant, although with different facilities, produces with the same manufacturing procedures, efficiently following the highest quality standards that comply with all the regulations established by the European Pharmacopoeia and the FDA.
Products that Improve Cellular Renovation
Currently there is a growing interest in cell therapy extracted from the patient’s own stem cells, unlike our products,
Cellular renovation therapies (CRT) provide sustained results without complications and represent a great economic saving in comparison. The products in the Biocell Ultravital line of
Cell Renewal Therapies are divided into 5 main groups that include:
Regeneration, Revitalization, Detoxification, De-inflammatory and Hormonal.
CRT have worked with great success in recent years as a preventive treatment, without discarding its effective action as a primary therapeutic. The treatment benefits are notorious for their adjuvant action in allopathic medicine. CRT, through their formulas, exclusively allow us to transform diseased or aging organs into healthy organs with a highly functional capacity. Their components activate a series of stimuli that cells need for a normal cycle of continuous renewal, and they can be incorporated into the body through injections or orally. These various components are assimilated by the body through endocytosis and a good part is introduced into the cells. This is produced by the emission of pseudopods until they completely encompass it to form a vacuole, which then fuses with the lysosomes to degrade the phagocytosed substance, which is known by the name of phagosome. This method is characterized by being the mode of nutrition used by cells through ingestion of foreign matter. In addition, it is one of the greater means of transport that they use to defend themselves against some cells of multicellular organisms.
From this mechanism and many other stimulating biochemical changes, nutrition begins for an effective CELLULAR RENOVATION. CRT brings a fresh genetic information contained in DNA and RNA, stimulating secretion inducing old or sick cells and reprogramming to operate properly, providing the recipient bodies, a large number of biochemical and enzyme substrates containing information needed to revitalize an organ, or a gland. CRT contains various compounds that are primarily responsible for properly nourishing cells, but, moreover, each of the formulas in a CRT contains cells and embryonal tissues that increase positive changes in cell cycle complementing in part dysfunctional lapses. This is how the different components are first incorporated as essential nutrients and as well, how the embryonic tissues reach the organ with low vitality and that need to be dynamized. This process is called CELLULAR RENOVATION and its benefits are perceived after several weeks, as it passes slowly from the cell to the tissue, from the tissue to the organ and from the organ to the system. Some specialists feel that the most important result of using CRT is the revitalization of the body’s immune defense mechanisms. When damage occurs to the cells that make up the different tissues and organs involved in the immune system, either through aging or environmental poisoning, the body becomes defenseless from both external invasion and internal degeneration. The damage caused to the organs of the immune system can be reversed by stimulating the body’s defense mechanisms to boost the health of the weakened organ.
Security System to Prevent Falsification
Biocell Ultravital has developed for the
4th generation a sophisticated security system for its products to prevent the repetition of copies and / or counterfeiting of our products. Moving forward, we will invest a great technological effort in each package to ensure that you will have an original product in your hand.
This security system is applied to new packaging that have a QR Scan code applied to a double security system, a first physical stage in the packaging that will reveal through a security tab if the product has been violated and a second with an implantation of sophisticated software that will allow you to check if the product you purchased is original through our website, or by downloading the new BIOCELL APP for Android and IOS for free.
The falsification of ethical and health products is a problem that is becoming increasingly important, and all the different therapeutic areas may be affected.
These counterfeits seek to pass for authentic products, copying the packaging material, the commercial image, the logo, the information brochures, as well as the shape and colors of the original product.
In addition, they use the same lot number, expiration date and other identifying elements of the authentic product. However, they are manufactured and placed on the market without the authorization of any health authority. These original and generic medicines, as well as vitamins are also falsified and even more so those products that enjoy prestige are the most vulnerable and these falsifications may contain active ingredients in incorrect doses or lower doses than those authorized, or the absence of active ingredients and even include some toxic elements. Many may even be manufactured under dangerous conditions that are not controlled. Thus, they can pose a significant risk to health and are sometimes especially difficult to identify.
In short, they look identical to the original product, but contain “uncontrolled” components that are life threatening.
he trade in counterfeit medicines is controlled by international criminal networks, and no region is exempt. Those countries with less controlled drug distribution systems are more vulnerable to this type of practice; However, the most developed countries are not spared from this evil, especially when patients purchase drugs on the internet or unauthorized websites. Unfortunately, in the past we have been victims of these unethical organizations and have had to report these facts to the authorities since many people especially in Asian countries, as well as Mexico and others in Central and South America are victims of misleading offers of therapies, even by unethical doctors who offer the products at prices lower than the real cost. However, in the end they spend more money due to the need to seek immediate clinical help as demonstrated on several occasions reported by us through our attorneys around the world from patients who were treated clinically for administering fake products.
