Manuscript Topics

Regenerative medicine and tissue engineering employ stem cells to repair and replace damaged cells and tissues of the body.  Stem cells and their uses have become so commonplace that it is estimated that there are now more than 500 stem cell clinics in the United States alone, offering “therapies” for almost any malady one can imagine.  However, many questions remain to be answered before everyday stem cell use in tissue engineering and regenerative medicine can become standard of care.  This special issue will address these issues including various stem cell sources, stem cell heterogeneity and does it matter, commonplace stem cell applications most likely to impact an individual’s everyday life, clinical variables that may impact clinical outcomes, medical regulations and the subsequent costs of regulation, as well as the future of stem cell therapy.

The most commonly utilized stem cell populations in regenerative medicine are the hematopoietic stem cells (HSC) and the mesenchymal stem cells (MSC).  Although embryonic stem cells (ES) and induced pluripotent stem cells (iPSC) have garnered recent attention, to date there are no clinical trials directly using these stem cell populations.  Instead both ES and iPSC are differentiated into mature cell populations for use in patients due to concerns over teratoma formation.  Both HSC and MSC may be obtained from multiple sources including bone marrow (HSC and MSC), umbilical cord blood (HSC), umbilical cord tissue (MSC only) and adipose tissue (MSC only).  It is unknown if one stem cell population is better (more efficacious) than another for different applications or for different patient groups.  When one thinks about routine stem cell use in the clinic there are three major categories of disease that immediately come to mind: orthopedic applications, neurological applications and cardiovascular applications.  These three categories are expected to affect almost 100% of all individuals and put the chance of needed stem cell therapy over one’s lifetime at 1 in 5.  When considering orthopedic applications we are thinking about long bone fractures and cartilage replacement in articular joints as well as reconstruction after severe trauma.  When thinking about neurological application one thinks about stroke, Parkinson’s disease and even Alzheimer’s disease as well as more commonplace applications such as traumatic brain injury (e.g., in soldiers).  Cardiovascular applications could include not only myocardial infarction (i.e., heart attack) but also congestive heart failure, viral cardiomyopathy and construction of heart valve replacements.  As discussed above, not only is it not known which stem cell population (HSC vs. MSC) and/or source is better for which application, it is also not known how long after an incident such as a stroke that one should administer the stem cells (hours, days or weeks?), the route of administration, the optimal cell dose to be used and if multiple infusions are better than a single treatment.  Each of these questions is begging to be addressed and answered.

The future of stem cells and its acceptance into the everyday arsenal of the practicing physician does not depend on continued proliferation of stem cell clinics, but rather the regulation and oversight of such establishments such that quantitative outcomes are used to make medical decisions that offer a better outcome to the patient without bankrupting their family.  The gradual acceptance that most stem cell procedures require an IND application from the FDA, not an IRB approval from a private, pay-to-play establishment, will result in better outcomes for more patients, with fewer side-effects and ultimately to lower costs and eventual third party reimbursement (i.e., insurance).  Oversight should not stifle progress but it may lower profit margins, at least temporarily.  However, such regulations have not seemed to prevent large pharmaceutical companies from earning billions of dollars in profits annually.  Only when a stem cell therapy produces the same results in the hands of multiple practitioners at affordable prices can a patient have confidence that their medical outcomes will be routinely positive without fear of losing either their life or their lifesavings.

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