Understanding Stem cell therapy for ED

What are stem cells?

Stem cells are immature cells that have yet to form specific functioning organ cells like pancreas or prostate. There are two types of human stem cells: Embryonic and Adult stem cells.

Both types are unspecialized cells which means that they cannot do any specific functions in the body, like a liver or a kidney cell does. However, adult stem cells have the potential to develop into specific types of cells in the body and only serve to repair certain specific body systems. Unfortunately stem cells that can become or repair any type of tissue, also called totipotent or embryonic cells are no longer present in the adult human body. It is critical to understand this difference. 

There are also other constraints. As the body ages, the number and type of stem cells also changes. The stem cells that stay in our body throughout one’s life are tissue specific except that they are aging so for example a skin stem cell will always give rise to a skin cell except that a stem cell that is 80 years old will not be quite the same as a stem cell that is 20 years old. 

How does stem cell therapy works?

It is important that patients understand that there are very few conditions for which stem cell-based therapies have been proven effective and are routinely implemented in medical practice. These are primarily limited to bone marrow stem cell transplantations to treat diseases of the blood and immune system such as leukemia and lymphoma. The reason for this that bone marrow stem cells can only produce new cells of the blood and immune system. No one has yet figured out how to transform bone marrow stem cells into other specific body organs like kidney, liver or erectile muscle tissue. In addition, nothing prevents the stem cells from migrating into the circulation after they are injected in the penis for example. Just because they are injected in a certain location it does not mean that they will remain localized.

Current research

Researchers are in the process of testing new stem cell therapies, but any new prospective treatments require clinical trials and a rigorous peer review process before they are accepted as safe and effective. Some bone, skin and corneal (eye) injuries and diseases can be treated by grafting or implanting tissues, and the healing process relies on stem cells within this implanted tissue. These procedures are widely accepted as safe and effective by the medical community. All other applications of stem cells, including treatment of ED, are yet to be proven in clinical trials and should be considered highly experimental.

FDA approved stem cell procedures

The FDA allows for removing stem cells from an individual and implanting the same cells into the same individual from whom they were removed only if the cells remain in their original form. Here is the catch, as previously mentioned, bone marrow stem cells can only become bone marrow or blood or immune system cells unless they are somehow manipulated which the FDA does not allow. So, without manipulation to somehow change these cells, how are these bone marrow stem cells recognize where they are being injected, in the penis, and how do they know which type of tissue they are supposed to repair or rebuild? If the cell’s DNA is manipulated or tricked to become penile muscle tissue, then the process of injecting these cells back into the penis would no longer be allowed by the FDA without rigorous clinical trials, and doctors performing this procedure would be breaking the law and subject to imprisonment. 

Is there any proof that stem cell therapy can cure ED?

None. To date there is no multi-center peer reviewed clinical trial data documenting that stem cell therapy can cure or restore erectile function. Researchers are in the process of testing new stem cell therapies, but any new prospective treatments require clinical trials and a rigorous peer review process before they are accepted as safe and effective. So far, no data is available documenting that stem cell therapy is effective for the treatment of ED.

How come clinics can claim that stem cell therapy can cure ED?

Stem cells treatment currently exist within a grey area of legality for medical regulatory councils within many countries. This has allowed for-profit stem cell clinics to flourish around the world. These clinics, largely unregulated and unconstrained by ethical guidelines, are thriving, despite the fact that their practices have not been proven to be safe or effective, and in some cases, have caused harm. Individuals who receive unproven stem cell treatments at for-profit clinics are taking on enormous medical and financial risks. For example, and as mentioned previously, here in the U.S. the FDA allows for removing the patient’s own stem cells from an individual and implanting human cells into the same individual from whom they were removed only if the cells remain in their original form. Clinics will exploit this loophole and perform the procedure while knowing that bone marrow stem cells can only give rise to blood cells and no other tissue cells, like erectile muscle tissue cells. 

What are some clues that the therapy offered is a scam?

Read the advertisement carefully and look for clues. For example, a clinic may claim that they possess a “clinically proven stem cell treatment for ED, a patented procedure using FDA-approved equipment”. Sounds legitimate right?  Except that “clinically proven” actually means that there are no peer reviewed multi-center clinical trials which were overseen by an independent Investigation Review Board. Otherwise the term “clinical trial” would be used in the advertisement. Furthermore, when one researches “the patent”, one discovers that it is only a concept or idea patent which is intended to cover the categories of medical services, namely, treatment of erectile dysfunction via stem cell enhancement and administration. That is, it! It is not a patent for a special technique or scientific breakthrough. The patented equipment referred in the advertisement is also nothing more than generic equipment to remove stem cells, nothing specific to ED treatment. 

Another clue that the treatment has yet to be proven effective is to look at the timeline of when it was first publicized, by whom, a publicly traded company vs. academic center and what data was available at that time that it was made public supporting the announcement.

For example, if the concept patent to treat ED by injecting stem cells, was filed at a certain date and then only 4 weeks later, the publicly traded company aggressively promotes stem cell therapy for the treatment of ED as well as the commercialization of the so called patented stem cell procedure for the treatment of Erectile Dysfunction, one then wonders how were these clinical trials performed in such short period of time (clinical trials always involve multiple test sites and 6 to 12 months follow up)? Another clue that the treatment lacks credibility is to note that the news release does not provide actual data and results from the treatment despite announcing its success. 

Conclusion

Presently the only effective and established treatments for erectile dysfunction include oral and injectable medications, external vacuum pumps and penile implants. None of these therapies are able to restore “normal” erectile function and it is therefore reasonable to search for new therapies, however that does not mean that one should try unproven treatments. At present, there is no evidence to suggest that stem cell treatment for ED is either safe or effective.