Unit 1 Project: Italian Stem-Cell Clinical Trial Controversy

Davide Vannoni
Photo by collanedilana

Stem-cells set the stage for one of the most controversial topics in Biology. These cells have the potential to become any cell in the human body, repair any tissue in the human body, and can replicate themselves for an unlimited amount of times. Recently, Nature journal critics stirred up some tension between Davide Vannoni’s (an Italian researcher) work on a stem-cell related treatment and the Italian government; the latter wishes to conduct a clinical trial to test the treatment’s validity. Even though the Nature journal argues against the Italian government conducting a clinical trial with Vannoni’s work, due to the flawed nature of Vannoni’s findings, progress with discovering a revolutionary stem-cell-related cure for diseases, like cancer, outweighs the trial’s financial expenses and must be conducted.

Stem-cells distinguish themselves from other cells in the body with their ability to replicate themselves indefinitely, and can become any cell (“The Stem Cell Controversy”). Under specific conditions, stem-cells can become the cells for a specific organ and insert themselves into that organ, which heals the tissues in that organ (“Frequently Asked Questions”). In certain parts of the body, like the stomach and bone marrow, the stem-cells can divide freely, while in other organs, like the heart and pancreas, the stem-cells can only divide under specific conditions (“Frequently Asked Questions”).

Stem-cell research monumentally influences developing new cures. The unique traits of stem-cells, like their ability to develop from generalized cells to cells with specialized functions, and their ability to divide without limit, make them a possible cure for difficult-to-treat diseases, like heart disease and diabetes (“Frequently Asked Questions”). Continued research furthers our understanding of how organisms develop from cells at early stages, and how stem-cells can replace damaged cells in adults.

Photo by hellaslive

Recently, the Italian government announced plans to watch over a clinical trial about a controversial stem-cell therapy method, which a Nature journal article avidly speaks against (“Trial and Error”). The article explains, because flaws exist within the data that researcher Davide Vannoni collected, the clinical trial, which will essentially waste all the money it requires, should not be carried out. (“Trial and Error”). The trial will cost roughly €3-million, or $3.9-million USD (“Trial and Error”).

In a clinical trial, participants receive experimental variables according to the research procedure (“Learn About Clinical Studies”). Experimental variables can include medical drugs or procedures, and behavioral changes, such as one’s diet (“Learn About Clinical Studies”). Clinical trials compare new medical procedures with traditional ones, determining the most effective and efficient products or treatment methods (“Learn About Clinical Studies”). The Italian government’s stem-cell therapy clinical trial tests the validity of Vannoni’s stem-cell treatment; if no compelling evidence supporting Vannoni’s method emerges, his work will lose credibility.

The Nature article asserts that this trial should not be conducted. This article mentions how Vannoni’s research is flawed, and even mentions how there is, “no good reason for [the trial] to be carried out” (“Trial and Error”). Statements like that represent only a single opinion; including it in an article takes away from the article’s credibility. The article acknowledges the opposing side by mentioning how those favoring Vannoni organized demonstrations with the patients’ families’ help, but the article fails to expand on this topic or connect it with the other ideas the paragraph, creating an impression that the author only included the statement for the sake of including it, and fails to comprehend how much it impacts the topic. Progressing through the article, the reader notices how the author only discusses one standpoint until the last paragraph; opinionated language appears, like when the author mentions the government taking a “pragmatic” approach to the topic, unlike Vannoni’s methods, and even refers to Vannoni’s practices as “scanty’ (“Trial and Error”). No matter how well the article hides it, name-calling always detracts from someone’s standpoint through reducing a reliance on facts when that person argues a point. This article’s opinionated tone requires an examination for consistency and validity among the facts presented.

After review, the data Vannoni bases his stem-cell procedure (known as Stamina therapy) on is flawed, and the Nature article establishes its argument upon this idea. The Stamina therapy procedure involves removing patients’ cells from their bone marrow and manipulating those cells in vitro (in a laboratory). Ideally, this should make the bone-cells into nerve-cells (“Abbott”). The Nature article mentions how Vannoni fails to provide adequate details regarding his procedures, and consistently refers to his patent (“Trial and Error”). Another source mentions this and explains an error with a picture on Vannoni’s patent (“Abbott”). The picture of a nerve cell Vannoni uses on his patent bears a

striking resemblance with a picture of a nerve cell used by another researcher named Elena

Schegelskaya, showing the inconsistency of Vannoni’s position (“Abbott”). Schegelskaya based her publication, with that photo, around turning bone-cells into nerve-cells, like Vannoni’s position, but both researchers used very different procedures (“Abbott”). The Nature article references this inconsistency, and while Vannoni’s findings are flawed, this does not imply that utilizing stem-cells from bone marrow is impossible, or that nothing will be learned if the government carries out the clinical trial.

Next, the Nature article discusses Vannoni’s relation with Good Manufacturing Practices (GMP). GMP encompasses regulations that the U.S. Food and Drug Administration erected, including ones regarding recordkeeping, personnel qualifications, and process validation (“What is GMP”). The Nature article warns that, “The very unlikeliness of the Stamina story should have made the Italian government extremely wary” (“Trial and Error”). Utilizing a retrospective statement this way, which mainly states the author’s opinion, alerts the reader about a possibly biased data presentation ahead. Even though the author of this Nature article presents truthful information, the author’s presentation style draws attention away from the facts presented, and even weakens claims, shown in this paragraph about Vannoni’s response to GMP. The paragraph explains how he prefers oversight-free environments, provides no detail regarding his procedures when prompted by authorities, asserts that the therapy can only function without GMP, and moves often to escape his opponents (“Trial and Error”). While the reader might assume that the author presents truthful information about Vannoni, this paragraph’s accusing and one-sided tone, established by the poor opening sentence, invokes a skeptical mindset within the reader, and makes the author’s claim, that the Italian government should not conduct the clinical trial, less creditable. This paragraph reminds the reader of Vannoni’s flawed research, though, and reinforces the author’s position.

Human stem cells
Photo by California Institute for Regenerative Medicine

Vannoni’s Stamina therapy may be based on flawed data, but the Nature article poorly explains why the Italian government shouldn’t look further into a topic like Stamina therapy by conducting a clinical trial. The author acknowledges the incredible potential that stem-cells possess, but falters when stating that a trial that could challenge some topics regarding stem-cells will hinder progress within that field (“Trial and Error”). Even if conducting further research on Stamina therapy yields no breakthroughs, new information about stem-cells can still be learned. If Vannoni’s Stamina therapy falls flat, we could wonder, “what made it not work in those conditions?”, even if the therapy stemmed from false data. Avoiding a potential conflict between a clinical trial and stem-cell research won’t benefit anyone. The trial demands a hefty amount of funds, but the finances are well worth getting closer to finding a cure that can save and improve millions of lives.

Stem-cells greatly impact the medical world as we continue to learn more about them. Bone marrow-based stem-cell procedures, similar to Vannoni’s Stamina therapy, currently aid cancer treatment (“Bone Marrow Transplantation”). Inside the bone marrow (sponge-like material inside bones), hematopoietic stem-cells can be found (“BoneMarrow Transplantation”). These stem-cells divide to produce more blood-producing stem-cells, and are used with peripheral blood cells (cells found in the bloodstream) in bone marrow transplant operations, called Bone Marrow Transplantation (BMT) and Peripheral Blood Stem Cell Transplantation (PBSCT) (“Bone Marrow Transplantation”). These procedures allow patients to receive high levels of chemotherapy and radiation therapy by replacing destroyed stem-cells in the bone marrow during these processes (“Bone Marrow Transplantation”). This is just one revolutionary way that stem-cell treatments have helped people overcome diseases, and the more familiar we are with stem-cells, the more uses we’ll find for them.

Human embryonic stem cell
Photo by California Institute for Regenerative Medicine

The Italian government should conduct the clinical trial for Stamina therapy, even though Vannoni constructed the Stamina therapy method using false data. The Nature journal argues against conducting the trial, citing Vannoni’s flawed data and the financial aspect of the trial as reasons why, but suffers from a highly opinionated presentation style, costing the article some credibility for its claims. The information we could obtain from the trial, even if Stamina therapy doesn’t get us anywhere, goes towards finding a cure for several, currently, un-curable diseases, and spending the finances towards saving and improving the lives of millions of people is well worth it. 

Works Cited

"Trial and Error." Nature 499.7457 (2013): n. pag. Nature.com. Nature Publishing Group, 09 July 2013. Web. 14 Feb. 2015. <http://www.nature.com/news/trial-and-error-1.13346>

"Frequently Asked Questions." Stem Cell Basics: Introduction [Stem Cell Information]. N.p., n.d. Web. 11 Feb. 2015. < http://stemcells.nih.gov/info/basics/pages/basics1.aspx>

"The Stem Cell Controversy." PBS. PBS, n.d. Web. 16 Feb. 2015. <http://www.pbs.org/wnet/innovation/episode6_essay1.html>

"Learn About Clinical Studies." Learn About Clinical Studies. N.p., n.d. Web. 14 Feb. 2015. <https://clinicaltrials.gov/ct2/info/understand>

"Bone Marrow Transplantation and Peripheral Blood Stem Cell Transplantation." National Cancer Institute. N.p., n.d. Web. 14 Feb. 2015. <http://www.cancer.gov/cancertopics/factsheet/Therapy/bone-marrow-transplant>

"What Is GMP." What Is GMP. N.p., 09 Nov. 2014. Web. 14 Feb. 2015. <http://www.ispe.org/gmp-resources/what-is-gmp>

Abbott, Alison. "Italian Stem-cell Trial Based on Flawed Data." Nature.com. Nature Publishing Group, 02 July 2013. Web. 19 Feb. 2015. <http://www.nature.com/news/italian-stem-cell-trial-based-on-flawed-data-1.13329>