Stem Cell Therapy as a medical procedure - approved
As mentioned before stem cell therapy is very "controversial, rather political issue" when it comes to health regulations in the various countries. Our science based information is independent from any political interpretation.
Stem cells are the building block of a human cellular structure which is regenerating itself via stem cells from birth to end of life. During lifetime stem cells are used up for its repair and maintenance activity in the body and as such over time the quantity and quality of stem cells for this natural healing process is fading away. Easily to see when a young person cuts its finger, it heals very quickly whereas in an elderly person the process of healing takes longer and often shows scaring. This situation is called stem cell exhaustion.
Many clinics worldwide are providing stem cell therapies to the displeasure of regulatory agencies and the industry because, instead of using expensive symptom relieving drugs, approved by the clinical pathway reflecting the safety and effectivity demands of heavy manipulated drugs, stem cell clinics, using the natural healing power of stem cells. Science has shown that stem cells are very intelligent structures knowing via its homing mechanism when, where and what to repair often even curing the root cause of a disease.
Under FDA regulations, an Institutional Review Board (IRB), is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
Medical procedures are regulated by IRBs, not regulated by the FDA. The purpose of reviews of the Institutional Reviewing Board (IRB) by the FDA is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials, e.g., informed consent documents and investigator brochures to ensure protection of the rights and welfare of human subjects of research.
We have to point out, that globally, a medical procedure based on an IRB protocol are not regulated by drug approving authorities, like the FDA or EMA, although those organisations try with guidelines to impose their influence on health related matters.
We furthermore like to emphasize that the need and its form of FDA regulations are based on the early 20th century philosophy and introduction of industrialized produced drugs, which did encounter problems in quality and safety in this early years of drug development. The production and science know how as well as its quality control and its application in the 21st Century is quite different and regulations should adopt to this change of knowledge, which clearly has been done already by various countries.
As mentioned before, science has advanced in the last 20 or so years exponentially, resulting in new and better understanding of the cellular structure of a body and its intervention. Furthermore autologous or even allogeneic stem cells used in medical procedures at clinics are not highly manipulated like chemical and biochemical drugs, or induced pluripotent stem cells highly modified from skin cells (so-called iPSC). When searching the internet you will finds many studies confirming the safety of stem cells and its exploratory therapies as a medical procedure, as well as early very positive results from FDA approved clinical trials, which regulatory authorities like to deney, stipulating them as early not yet well documented results.
This, besides the fact that thousands of clinics worldwide are doing stem cell therapies as a medical procedure very successful to improve quality of life in individual cases, the FDA lost its legal case against the Cell Surgical Network (CSN), California, last December, as the US court ruled that stem cells from fat extracted by the CSN method and used at the same body are not drugs and therefore such a procedure is not regulated by the FDA.
Stem cells are the building block of a human cellular structure which is regenerating itself via stem cells from birth to end of life. During lifetime stem cells are used up for its repair and maintenance activity in the body and as such over time the quantity and quality of stem cells for this natural healing process is fading away. Easily to see when a young person cuts its finger, it heals very quickly whereas in an elderly person the process of healing takes longer and often shows scaring. This situation is called stem cell exhaustion.
Many clinics worldwide are providing stem cell therapies to the displeasure of regulatory agencies and the industry because, instead of using expensive symptom relieving drugs, approved by the clinical pathway reflecting the safety and effectivity demands of heavy manipulated drugs, stem cell clinics, using the natural healing power of stem cells. Science has shown that stem cells are very intelligent structures knowing via its homing mechanism when, where and what to repair often even curing the root cause of a disease.
Under FDA regulations, an Institutional Review Board (IRB), is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
Medical procedures are regulated by IRBs, not regulated by the FDA. The purpose of reviews of the Institutional Reviewing Board (IRB) by the FDA is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials, e.g., informed consent documents and investigator brochures to ensure protection of the rights and welfare of human subjects of research.
We have to point out, that globally, a medical procedure based on an IRB protocol are not regulated by drug approving authorities, like the FDA or EMA, although those organisations try with guidelines to impose their influence on health related matters.
We furthermore like to emphasize that the need and its form of FDA regulations are based on the early 20th century philosophy and introduction of industrialized produced drugs, which did encounter problems in quality and safety in this early years of drug development. The production and science know how as well as its quality control and its application in the 21st Century is quite different and regulations should adopt to this change of knowledge, which clearly has been done already by various countries.
As mentioned before, science has advanced in the last 20 or so years exponentially, resulting in new and better understanding of the cellular structure of a body and its intervention. Furthermore autologous or even allogeneic stem cells used in medical procedures at clinics are not highly manipulated like chemical and biochemical drugs, or induced pluripotent stem cells highly modified from skin cells (so-called iPSC). When searching the internet you will finds many studies confirming the safety of stem cells and its exploratory therapies as a medical procedure, as well as early very positive results from FDA approved clinical trials, which regulatory authorities like to deney, stipulating them as early not yet well documented results.
This, besides the fact that thousands of clinics worldwide are doing stem cell therapies as a medical procedure very successful to improve quality of life in individual cases, the FDA lost its legal case against the Cell Surgical Network (CSN), California, last December, as the US court ruled that stem cells from fat extracted by the CSN method and used at the same body are not drugs and therefore such a procedure is not regulated by the FDA.
The general assumption is that stem cell therapies as a medical procedure are safe, I personally did IV-injection of MSCs from umbilical cord tissues about 4 years ago the first time and have the energy and health of a much younger person at a 77 young cellular structure!
In order not to run into regulatory difficulties we have to point out that this website and its content cannot be considered as a medical advice, but reflects science opinion for educational purpose only.
Here are details of the activities of my US partner, Cell Surgical Network, who are studying the investigational use of Adipose Derived Stem Cells (ADSC's) for clinical research and deployment. We are inviting interested patients to review the site as well as contacting us for further questions about such cellular therapies.
CSN is presently studying the following diseases with a patient's own stem cells, by harvesting fat cells in an about 20 minutes lasting specialist procedure from a person. After harvesting the fat, the stem cells are isolated from the fat and can be deployed through veins, arteries, spinal fluid, subcutaneously, or directly into joints or organs. The whole procedure is minimally invasive and lasts about three hours. As mentioned before if you are interest in any of the below investigating studies, please kindly contact us.
Aristoloft has various international partners and is studying stem cells in antiaging therapies in India for as well as Autism in a specialist European clinic. If you are interested in such therapies please do not hesitate to contact us.
