Industry Overview: Stem Cell Research

By Danny Restivo (3/17/17)

In 2016, Cell Stem Cell, a leading medical journal for regenerative medicine, released a study showing 570 stem cell treatment facilities in the United States. In their advertisements, many of these clinics lauded an ability to treat degenerative diseases with stem cells. Research suggests that stem cells might be useful in the treatment of certain diseases like Parkinson’s, ALS, or arthritis, among others. However, many scientists question the legitimacy of these claims, citing a need for more research and definitive trials. While the Food and Drug Administration allows clinics to inject patients with their own stem cells, they prohibit “manipulation” of these cells.

Stem cells became the center of controversy in 2001 after President George W. Bush banned federal funds from stem cell research using human embryos. In recent years, scientists have circumvented this ethical dilemma by culturing and rejuvenating stem cells from healthy adults.  Doctors can now take cells, such as a skin cell, and repurpose it back its early “pluripotent” stage where it can then turn into any cell, such as one that serves heart tissue. Whether these cells prove effective in treating degenerative conditions remains in question, but it hasn’t stymied enthusiasm from patients seeking treatment for chronic ailments.

The FDA allows clinics to inject patients with stem cells under certain criteria. However,many of these clinics flout 2000px-stem_cell_treatments-svgFDA regulations, including a stipulation on “minimal manipulation,” and a mandate that stem cells must come from a patient’s body. These clinics also sidestep guidelines by framing their work as experimental and research-driven. Furthermore, a recent study revealed many unregulated clinics use cells extracted from fat tissue, but the FDA says there’s no evidence they work. For example, some clinics advertise using cells from fat to help treat neurological disorders like Parkinson’s or Multiple Sclerosis. Unfortunately, fat cells do not normally control neurological movement. However, these clinics point to a number of personal stories that ultimately endorse stem cell treatment, including high profile athletes.

After experiencing a ligament tear in his elbow that ended his 2016 season, Los Angeles Angels pitcher Garret Richards opted to receive stem cell treatment instead of the invasive Tommy John surgery. In the case of Richards, doctors extracted bone marrow from his pelvis before injecting the plasma into his injured elbow. In February, Richards was at spring training throwing a fastball at 98 mph. New York Mets Pitcher Bartolo Colon received similar treatment in 2011 to help repair his shoulder, and continues to pitch at 43-years-old. While he’s never publicly admitted it, reports have surfaced that quarterback Peyton Manning sought stem cell treatment in Europe after suffering a neck injury with the Indianapolis Colts in 2011.

While some believe stem cells have rejuvenated athletic careers, others point to regenerative medicine’s lifesaving potential. Sarah Hughes, a 25-year-old from Texas, was born with a rare form of juvenile arthritis. Because of immense pain, she was hospitalized for a significant portion of her youth, weighing only 83 pounds at one point. In 2014, she began seeking stem cell treatment. She had her own stem cells cultured in a Houston lab before traveling to Mexico to undergo treatment. FDA law does not allow a clinic to inject her with manipulated stem cells in the United States. A healthy Hughes attended President Donald Trump’s recent address to Congress as the guest of Rep. Pete Olson (R-TX). Trump referenced the plight of Hughes and Megan Crowley, a 20-year-old Notre Dame Sophomore, during his speech. Like Hughes, Crowley was born with a rare disease and did not expect to live past a few years, but sought regenerative treatment.

In his speech, Trump referenced a need to cut federal regulations on companies seeking to innovate new treatment methods.

“..our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan’s life, from reaching those in need. If we slash the restraints, not just at the FDA but across our Government, then we will be blessed with far more miracles like Megan.”

In September, Hughes spoke in Maryland during an FDA-hosted public hearing on potential stem cell regulations. While certain speakers urged for looser stem cell regulations, others suggested caution and cracking down on those flouting the law. The FDA’s rules are pending, but the agency has only cleared one stem cell therapy product, Hemacord, which helps to restore low blood counts with patients having certain blood disorders. Conversely, the FDA officials have only sent one warning letter to a stem cell clinic in California.

Although progress looms, troubling stories regarding unregulated stem cell clinics have surfaced. In some cases, patients seeking alternative treatment have traveled to Russia, 13982409504_61de86a0ec_bMexico or Europe only to return home and to have their conditions worsened with malignant tumors. Doctors and researchers say stem cells can divide rapidly, creating tumors and other mutations. While most of these cases have occurred overseas, doctors and researchers see it as cautionary tale for a treatment that needs further research and oversight.

In August, the National Institute of Health announced it would lift its ban on funding research that uses human stem cells and animal embryos. The ban’s removal comes after research offered potential for growing human tissue and organs in animals. In one case, a team of researchers found that putting rat stem cells into the embryo of a mouse ultimately lead to a rat pancreas in the mouse. The NIH is now interested in injecting human stem cells into pig embryos in an effort to create human kidneys or livers. However, the NIH would continue a ban on funding any research that mixes animal embryos with human egg or sperm. Many people have questioned the ethics surrounding the injection of human stem cells into animal embryos, but the research could prove invaluable for people in need of a life saving organ transplant.

In light of these research developments, analysts believe the stem cell market will significantly increase in the next five years. Predictions vary, but a March report from a French-based research firm says the stem cell therapy market will grow by 11 percent from 2016 to 2021, totaling $145.8 million. Another marketing research firm predicted the entire global stem cell market hitting $297 billion by 2022. Both reports cited an increase in private and public partnerships, the evolution of stem cell therapies and a belief that looser regulations in the United States will help accelerate the market.

While President Trump has not made definitive public statements on embryonic stem cell research, his Secretary of Health and Human Services, Tom Price, has long opposed federal funding from embryonic stem cell research. A view echoed by Vice President Mike Pence. Now that embryonic stem cell research has taken a back seat to pluripotent stem cell research, it’s unclear what the administration’s stance is on regenerative medicine.

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