The guidelines for the clinical transplantation of stem cells part 12

stem cells

medical illustration of the function of stem cells in the human body

 

What should I be cautious about if I am considering a stem cell therapy?

Claims based on  patient testimonials:

Patients want to believe so much that a treatment is helping them that they can convince themselves that it has. They may even have experienced some recovery unrelated to the treatment. Unless there has been carefully evaluated clinical research it is very difficult to know what is a true effect of the treatment and what you can expect.

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The guidelines for the clinical transplantation of stem cells part 11

stem cells

medical illustration of the function of stem cells in the human body

 

What should I look for if I am considering a stem cell therapy? 

You need to be sure that there is good scientific evidence that the treatment is safe and effective, that your rights as a patient are being respected. To begin, ask evidence that:

  • Preclinical studies have been published, reviewed and repeated by other experts in the field.
  • The providers have approval from an independent committe such as an Institutional Review Board or Ethics Review  Board to make sure the risks are as low as possible and are worth any potential benefits, and that your rights are being protected.
  • The providers have approval from a national or regulatory agency, such as the Food and Drug Administration or the European Medicines Agency for the safe conduct of clinical trials or medical use of a product for this disease

Some smaller research studies may not need this level of regulatory approval, but must have approval from an independent review committee and support from the clinical and administrative leadership where the procedure will be done

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The guidelines for the clinical transplantation of stem cells part 10

stem cells

medical illustration of the function of stem cells in the human body

 

How do I know if an approved stem cell therapy is safe?

No medical treatment can ever be described as completely safe. There are risks involved with all medical treatment, some small, some great. These risks, even if they are small, should be explained clearly to you by a medical proffessional.

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The guidelines for the clinical transplantation of stem cells part 9

stem cells

medical illustration of the function of stem cells in the human body

 

The informed consent form for a clinical trial should include:

  • that the trial involves research and why research is being done
  • what the study treatment is; if a randomized trial
  • what the chance of you receiving different treatments is (placebo or alternative treatment)
  • what other medical options there are
  • what is involved in the research study before, during and after treatment including procedures like blood-draws
  • who will perform the study
  • how long the study will last
  • the risk of the treatment
  • contact details of the point person and contact details of an independent organization that protects patient rights
  • your responsibilities as a subject and information on who may see your research/medical data and your rights to confidentiality
  • your right to be informed of any new information that may effect your decision to continue participating in the research study
  • the circumstances under which you may be withdrawn from the trial
  • your right to withdraw at any time without consequence
  • how many patients are involved in the study
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The guidelines for the clinical transplantation of stem cells part 8

stem cells

medical illustration of the function of stem cells in the human body

 

What is an informed consent form or treatment consent form?

An informed consent form or treatment consent form outlines your role and what might happen to you. It should clearly provide a detailed description of the treatment or procedure in language you understand. It should explain your options for treatment, your rights and your responsibilities. A consent form is a good way to get information you need.

You should receive a consent form for any experimental stem cell treatment, even if the treatment is not part of a clinical trial. It should emphasize the unproven nature of the treatment and outline the specific risks associated with new stem cell therapies.

Once  you have read and understood the consent form and have had your questions answered, the form should be signed by you (or your legal representative) and the person providing the information. You should receive a copy of this form.

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The guidelines for the clinical transplantation of stem cells part 7

stem cells

medical illustration of the function of stem cells in the human body

 

What is a clinical trial?

A clinical trial is a research study designed to answer specific questions about a new treatment or a new way of using current treatments. Clinical trials are used to establish whether new treatments are safe and effective. It is very important to understand that the new treatment being tested is unproven. It may not be better than, or even as good as, existing treatments.

Some research studies are not trials. In some cases, new experimental treatments might be tried on a very small number of people  before a clinical trial is started. Again, the new treatment being tested is unproven.

The fact that a procedure is experimental does not automatically mean that it is  part of a research study or clinical trial. Experimental procedures should be made part       of a formal research study at an early stage in order to determine whether they are safe and effective.

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The guidelines for the clinical transplantation of stem cells part 6

stem cells

medical illustration of the function of stem cells in the human body

 

What are the differences between an aproved clinical treatment and an experimental intervention?

An approved clinical treatment is a medical practice that has been shown through a formal process of clinical trials to be reasonably safe and effective for treating a particular disease or condition. Normally, such treatments will be approved by a national or regional regulatory agency, for example, the US Food and Drug Administration (FDA) or the European Medicine Agency (EMEA).

An experimental intervention is new, untested, or different from the usual medical treatment. It has not yet been proven that it is safe or that it will work in treating the particular disease.

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