Human cell and tissue sampling has become a hot topic, as evidenced by recent coverage in The New York Times and other media outlets.1,2 The use of human cells—fetal cells, in particular—may become a topic of conversation where people, including scientists lacking domain-specific knowledge, will be asked for an opinion.
Members of cohorts for testing drugs have traditionally been adult males. Package inserts for drugs, even those sold OTC, caution that the product has not been tested for efficacy and safety in women, infants or minors. The FDA has expressed concern about gender bias. Age bias is less of a concern—sampling the young often raises parental objections, which makes it difficult to recruit cohorts.
Starting in January 2016, grants awarded by the National Institutes of Health (NIH) will require “strong justification” if the testing cohorts include only one gender.3 The equality requirement might be avoided if the research focuses on sex-specific organs. However, with the current success of Viagra and repurposing of drug candidates, it seems prudent to at least scout the other gender for possible side effects. But where to get cells?
Lai1 points out that disruptive changes in technology with tissue, organs and tumors on a chip are opening new paradigms for testing efficacy and safety for humans. The ability to construct interconnected functional networks of chips made with human lung, heart, liver, kidney thyroid, etc., facilitates measurement of efficacy and toxicity. Tumors on a chip offer the potential to study cancer genesis, metastasis and morbidity.
I’m particularly impressed with efforts by groups that use computer-aided data mining to elucidate causal pathways of toxicity. In silico methods such as those promoted by sbv IMPROVER (Systems Biology Verification combined with Industrial Methodology for Process Verification in Research) help life scientists develop tools to describe the complex interrelationships that in vivo biological systems employ. Specifically, sbv IMPROVER seeks to develop the training set, including algorithms, that researchers can use to test predictions in vivo.
Ultimately, it is in vivo testing of humans that counts, which requires either humans or human cells. The latter seem to be better suited to research. With tissue or organ chips, one can characterize and group many genotypes and phenotypes. Age and gender are important variables that can be included.
The availability of live cells with a known pedigree is essential. This is a rub point now, for example, the conflict over tissue obtained from aborted fetuses. In 2014, the NIH funded $76 million for research involving fetal tissue.4 Fetal tissue (FT) is a starting point for many research plans. But since FT is enriched in stem cells, it is also used a source of seed cells for growing organs for chips. Grady4 and Holt2 point out that stem cells from adults might someday replace fetal stem cells in research and therapy, “but the science is not there yet.”
To use FT, a mother’s consent is required. Several firms collect and process FT for research use. These firms may pay a small fee (usually less than $100) to the operator of the abortion clinic to cover collection and shipping costs. The cells are processed and packaged according to established protocols requested by the customer, which can be expensive—“a vial containing five million frozen fetal liver CD133+ stem cells can cost more than $24,000.”4
Recent publicity by imposters seeking to buy FT has caught the attention of Congress and ignited yet another round of the vitriolic debate over abortion rights.
Thus, Congress should consider legislation that recognizes:
- Parents have the right to donate tissue of their progeny.
- A pregnant woman has the right to authorize the collection and distribution of human samples of her nonviable fetus for medical research.
- A pregnant donor can authorize the annotation of the sample in item 2 above to aid in creating a pedigree of the FT.
- Institutions that further process FT for research and therapeutic purposes should be regulated to prevent price gouging.
Scientists need access to fetal tissue to advance their research, and an environment that supports advanced research techniques, especially if they can potentially improve our health and well-being.
References
- http://www.nytimes.com/2015/07/27/opinion/improving-gender-equity-in-medical-research.html
- http://www.nytimes.com/2015/07/30/opinion/the-case-for-fetal-cell-research.html
- http://www.nytimes.com/2015/07/19/opinion/sunday/why-science-needs-female-mice.html
- http://www.nytimes.com/2015/07/28/health/fetal-tissue-from-abortions-for-research-is-traded-in-a-gray-zone.html
Robert L. Stevenson, Ph.D., is Editor Emeritus, American Laboratory/Labcompare; e-mail:[email protected]