Answers to Frequently Asked Questions

About Stem Cell Treatments

1. Are stem cell treatments dangerous? Can stem cells cause cancer?

2. I signed a consent form and had a procedure, but now I am having second thoughts. What should I do?

3. Are adult (tissue-specific) stem cells as good as embryonic stem cells in treating diseases?

4. I talked with a clinic that said it would be isolating a type of stem cell called a mesenchymal stem cell from bone marrow, fat or blood. The doctor says that these cells will turn into the type of cells that are needed to treat my condition (heart cells/brain cells/liver cells). Is that correct? 

About the Scientific Process

1. I saw a clinic website that had a story of someone who got better after a stem cell treatment. Why aren't patient testimonials scientific evidence?

2. What is peer-reviewed literature and why is it important? What does independently verified mean?

3. Can you recommend any clinics or clinical trials that are doing legitimate therapies for specific conditions? 

About Laws and Regulations

1. If providing unproven stem cell treatments is so dangerous, why isn't it illegal?

2. Are treatments using my own (autologous) stem cells safe? Why should these be regulated?

3. Who decided that the process of clinical translation described on this website was the best way to evaluate treatments? 

About This Web Site

1. What is the purpose of this Web site? Are you trying to prevent people from going to these clinics?

2. I would like to ask about a clinic I think is providing unproven treatments. How do I submit a clinic for review by the ISSCR?

 

About Stem Cell Treatments

1.  Are stem cell treatments dangerous? Can stem cells cause cancer?

Every medical procedure has risks. A goal of clinical trials is to determine if the possible benefit of a treatment outweighs the risks. A possible risk of some stem cell treatments may be the development of tumors or cancers. For example, when cells are grown in culture (a process called expansion), the cells may lose the normal mechanisms that control growth or may lose the ability to specialize into the cell types you need. Also, embryonic stem cells will need to be directed into more mature cell types or they may form tumors called teratomas. Other possible risks include infection, tissue rejection, complications arising from the medical procedure itself and many unforeseen risks.

2. I signed a consent form and had a procedure, but now I am having second thoughts. What should I do?

Review the procedure you received with a trusted physician who is familiar with your particular condition. He or she should be able to help you determine if what you received was a legitimate treatment, and if you had any resulting changes to your condition, either positive or negative.

3.  Are adult (tissue-specific) stem cells as good as embryonic stem cells in treating diseases?

Embryonic stem cells and adult or tissue-specific stem cells have very different characteristics. Not every stem cell will be able to do everything. Embryonic stem cells have the ability to become any cell type in the body, which makes them especially interesting to stem cell researchers, but they will need to be directed into a more mature cell type to be a useful treatment. Tissue-specific stem cells are already specialized and generally can only become a limited number of cells types. It is important to study both embryonic and tissue-specific stem cells to determine which cell types will be best suited to treat which diseases.

Read more about the different types of stem cells.

4.  I talked with a clinic that said it would be isolating a type of stem cell called a mesenchymal stem cell from bone marrow, fat or blood. The doctor says that these cells will turn into the type of cells that are needed to treat my condition (heart cells/brain cells/liver cells). Is that correct?

Mesenchymal stem cells are known to form cartilage, bone and fat. What other roles these cells may have is controversial in the scientific community. There is insufficient evidence to show that these cells can differentiate into other cell types, and they have not been shown to be to be safe and effective for many of the conditions for which some clinics claim to utilize them.

About the Scientific Process

1.  I saw a clinic Web site that had a story of someone who got better after a stem cell treatment. Why aren't patient testimonials scientific evidence?

Testimonials may come from patients who have been specifically selected by the clinic, and they do not take into account all of the patients that were treated. Other patients may have experienced no benefit or their conditions may have worsened.

In addition, there are a number of reasons why a person may feel better that are not related to the stem cell treatment. The belief that a treatment will work can lead to psychological and even physical improvement. This is called the 'placebo effect'. There may also be other treatments unrelated to stem cells that may make a person feel better, such as changes to diet or physical therapy. Also, the severity of symptoms of many conditions can change over time, resulting in temporary improvement or decline. Without first testing a procedure in a clinical trial with a control group it is nearly impossible to determine the real effect of any therapeutic intervention.

2. What is peer-reviewed literature and why is it important? What does independently verified mean?

Peer review means that before a scientific paper is published it is first examined by other experts in the field. These experts judge whether the authors have followed scientific methods and whether the results of their experiments support their claims. Independently verified means that more than one research group has observed the same phenomenon or demonstrated the same principle. Independent evidence from multiple groups is a good indication that the research and the conclusions are accurate.

3.  Can you recommend any clinics or clinical trials that are doing legitimate therapies for specific conditions?

The ISSCR cannot recommend specific clinics or clinical trials. A list of registered clinical trials can be found at the U.S. National Institutes of Health clinical trials registry or the World Health Organization's International Clinical Trials Registry Platform. Talk with your doctor to determine which clinical trials are most appropriate for your particular situation.

Read more about How Clinical Trials Work

About Laws and Regulations

1. If providing unproven stem cell treatments is so dangerous, why isn't it illegal?

Cell transplantation is a relatively new technology and the appropriate laws and regulations may not have been developed or applied to the field. Laws and regulations vary from country to country. Depending on the country and the nature of the procedure, there may be no laws restricting stem cell treatments, making them simply unregulated.

2.  Are treatments using my own (autologous) stem cells safe?  Why should these be regulated?

While your own cells are less likely to be rejected by your immune system, this does not necessarily mean the cells are safe to use as a therapeutic treatment. The methods used to isolate, modify, grow or transplant the cells may alter the cells, could cause infection or introduce other unknown risks. Transplanting cells into a different part of the body than they originated from may have unforeseen risk, complications or unpredictable outcomes.

3. Who decided that the process of clinical translation described on this Web site was the best way to evaluate treatments?

In the past there have been instances where human beings were experimented on without regard to their rights, health or safety, for example the experiments conducted by Germany on prisoners during World War II. In an effort to protect people from such practices, there have been several guidelines written over the last several decades describing a code of ethics to be followed when conducting experiments on human subjects, such as the Nuremberg Code, Declaration of Helsinki, and the Belmont Report. These guidelines have some differences, but the basic principles are similar.

Read more about How Science Becomes Medicine

About This Web Site

1. What is the purpose of this Web site? Are you trying to prevent people from going to these clinics?

The purpose of this Web site is to provide patients, their families and doctors with as much information as possible so that they can make an informed decision about stem cell-based treatments. The ISSCR respects patients' rights to utilize this information in the manner they see appropriate and to make their own choices.

2. I would like to ask about a clinic I think is providing unproven treatments. How do I submit a clinic for review by the ISSCR?

The ISSCR is not able to comment or provide information on specific clinics at this time.