A MEDICAL/LEGAL PERSPECTIVE ON STEM CELL THERAPY: A SCIENTIFIC BREAKTHROUGH OR SNAKE OIL?

• Author: Hodge, Samuel D., Jr.

Science is an art, and science is a business. Unfortunately, the business aspect can cloud judgment. -Tennille Ludwig, WiCell Stem Cell Bank (1) A Google search of stem cell therapy yields over 200 million listings. (2) These references, however, will demonstrate a potpourri of mixed signals from those espousing the virtues of stem cells in the treatment of problems such as spinal cord injuries, strokes, Alzheimer's disease, diabetes, and heart conditions (3) to others who describe the therapy as a fraud, (4) fake treatment, (5) and a bogus cure. (6)

The notion of a miracle cure and body tissue mending itself provides a unique appeal, (7) and there is little doubt that stem cell and regenerative therapies present great promise by offering potential treatment options for a host of maladies. (8) Regardless of the possibilities for this medical breakthrough, there is growing alarm about the increasing number of healthcare providers undermining the science. (9) This is the result of for-profit clinics and physicians making a number of unsupported assertions about the curative powers of stem cell therapy and in taking advantage of those in desperate circumstances who are eager to try any measure despite the negligible evidence of efficacy. (10) This Article will explore the controversy concerning stem cell therapy, and will explain why the government has become actively involved in regulating this field and why scientists and ethicists are advocating litigation as a way to curb for-profit stem cell therapy clinics.

1. WHAT ARE STEM CELLS?

   Most people have heard of stem cells, but few understand their significance or role. They are the "body's master cells": (11) those from which all other cells with a specialized role are created. (12) This is because stem cells have the unique ability to transform into a variety of forms "during early life and growth." (13) In many places, stem cells act as an "internal repair system," separating without limit to create other cells. (14) As stem cells divide, each new unit has the ability either to stay a stem cell or to transform into another kind with a more particular purpose, such as brain, liver or red blood cells. (15) In certain body parts, such as bone marrow, they regularly dispatch "replacement cells to repair worn out tissue." (16)

   Several factors make stem cells unique. They are unspecialized cells that can recreate themselves through cell division even after being dormant for extended periods of time. (17) They can also be induced to become organ specific with unique functions. (18) For instance, in certain body parts, stem cells can split to restore damaged tissue while in others, such as the heart or pancreas, they only divide in specific situations. (19)

   1. Types of Stem Cells

   Stem cells are classified as either embryonic or adult. (20) The first type, also known as pluripotent, are created "from three- to five-day old embryos" and continue to recreate into any cell in the body, (21) which affords them the ability to regenerate or fix diseased tissues or organs. (22)

   Adult stem cells form the second category and are classified as undifferentiated that split "to replenish dying cells and regenerate damaged tissues." (23) They can renew regularly to guarantee that a collection of stem cells are accessible to create specific cell types. (24) These units "are found in small numbers in most adult tissues, such as bone marrow or fat," (25) and they are considered "multipotent" because they can create "several kinds of cells in their home tissues." (26) These cells, however, don't create cell types aside from their specific kind. (27) In other words, heart stem cells will not create brain cells, and liver stem cells will not transform into pancreatic tissue. (28)

2. MEDICAL USE OF STEM CELLS

   1. Embryonic Stem Cells

      Stem cell research began in Germany in 1838 when Theodor Schwann and Matthias Schleiden became the first scientists to recognize that all life originates from cells and proposed the "cell theory of life." (29) Through microscopic analysis, doctors started to understand the various characteristics and functions of the two hundred cell types that form the human body. (30) As strange as it might seem, the discovery of stem cells happened as a result of the dropping of the atomic bomb on Japan in 1945. (31) Radiation was not responsible for the immediate deaths of the many people. Rather, radiation destroyed the stem cells that resided in their bone marrow. (32) It is now recognized that the stem cells in bone marrow grow into all of the cells in our blood stream and immune system. (33)

      The study of stem cells in the United States started in the 1950s, and a physician at the University of Minnesota, performed the first successful bone marrow transplant in 1968 on a child with an immune deficiency. (34) Researchers consequently learned how to transform embryonic stem cells from mice, and in 1998, invented a way to extract them from a human embryo and cultivate them in a laboratory. (35) While these stem cells originate from embryos, researchers have invented a way to create comparable multiuse cells from these units. (36) This research, however, requires the destruction of embryos that are only a few days old and has been the subject of continuing ethical, religious, and political debate. (37) This controversy arises because some individuals believe that life begins at conception, so an embryo has the equivalent moral significance and entitlements of an adult or child. (38) Another reason is that certain societies and religious customs do not believe that a human life should be used "as a means to some other end" even though that application might be a noble one. (39)

      These developments, nevertheless, excite the medical community because of the capacity of stem cells to transform into a variety of cells that can assist in the restoration of injured tissue and organs. This is especially true of embryonic cells because of their ability to change "into any cell in the body." (40) Federally funded researchers in the United States have expended $1.4 billion examining stem cells, and globally, "there are currently twenty-nine clinical studies looking at the potential uses of embryonic stem cells in medicine. (41) While the government wanted to stimulate interest in stem cell research, President George W. Bush enacted a law in 2001 "limit[ing] funding for embryonic stem cell research to 19 pre-existing human embryonic stem cell lines," thereby dealing a major blow to the research community. (42)

      Fortuitously, funding was still available on the state level, and California led the pack in this regard. (43) During the 2000s, however, it became obvious that the federal limitation on research involving embryonic stem cells was an overreach. (44) President Obama recognized this problem and "removed many of these federal restrictions." (45)

   2. Adult Stem Cells

      Most of the political debate involving stem cells is focused on embryonic and not adult stem cells. (46) This has allowed clinical trials using the latter cells to proceed, (47) and scientists have discovered a simple way to transform adult stem cells into pluripotent ones opening a world of regenerative possibilities. (48) Adult stem cells enjoy the widest application in blood-forming stem cells, which are the primary element in bone marrow and umbilical cord blood transplants; the only stem cell therapy that has been approved by the federal government. (49) In this regard, over seventeen thousand individuals with cancers of the blood are successful recipients of stem cell transplants. (50)

      A major hurdle in using stem cells to treat illness is that physicians do not fully comprehend the many facets of disease including the genetic and molecular signals that cause abnormal cell division and variations that cause a specific disorder. (51) Another problem is the propensity of modified master stem cells to develop tumors in a living organism. (52) It turns out that using viruses to genomically change a stem cell can prompt the formation of cancer-causing genes. (53)

      Adult stem cells offer much promise in regenerative medicine and a new source of multipotent stem cells is fat or adipose tissue. (54) This is because fat contains many blood vessels, making it a good reservoir for stem cells. (55) Unlike the cells taken from bone marrow, they can be easily obtained using minimally invasive techniques, much like liposuction, with a low morbidity rate. (56) As of 2016, more than 130 clinical studies dealing with this technique were listed on the website of the U.S. National Institutes of Health (NIH). (57) They cover a vast array of applications including "soft tissue regeneration, skeletal tissue repair, ischemic injuries, myocardial infarction[,]... immune disorders [,]... intervertebral disc degeneration and pulmonary disease." (58)

      These fat cells, however, are limited in that they cannot be transformed into mature cells for most bodily tissue and can only be utilized safely if they are properly fitted to the tissue and disease being treated. (59) In fact, "[t]he scientific consensus is that stem cells taken from fat or bone marrow are not as malleable as embryonic cells, meaning that rather than turn[ing] into completely different cells, they mostly create more of the same tissue." (60) The bottom line is that stem cell therapy is currently recommended for only a small number of blood disorders, such as leukemia and lymphoma. (61) Likewise, Europe, Japan and South Korea have a limited number of approved applications for stem-cell products. (62)

3. FOR-PROFIT CLINICS

   The U.S. Food and Drug Administration (FDA) currently approves the use of stem cells for the treatment of about 80 diseases, but there is much excitement about other possible uses. (63) The years that have elapsed between the initial promise demonstrated by these cells and FDA support of them as a reliable and effective technique have led some...