Human blastocyst, Getty Images
For more than 30years, scientists have followed a rule they imposed on themselves to avoid growing a human embryo in a lab dish for more than 14 days.
Until recently, the "14-day rule" was largely academic. Scientists couldn't grow themfor that long if they wanted to.
But in 2016, two teams of researchers reached 12days, and in 2019, another group grew monkey embryos for 19 days.
These advances have spurredsome scientists to argue in two recent papersthat the 14-day rule should bemodified or dropped. There's a lot to be learned by pushing embryos out to 28 days, they say.
The regulatory committee of theInternational Society for Stem Cell Research, which lays down guidelines for the scientificfield,has been debating the issuefor months and is expected to issue its final decision this month.
Some ethicists and scientistsare concerned that revising the rule just asit becomes technologically feasible to break it is ridiculous and morally repugnant.
"If you abandoned every rule or law that inhibits you as soon as it inhibits you, we'd live in a lawless world," said Ben Hurlbut, a historian of science at Arizona State University.
And somepeople consider human embryo researchto be unethical at any stage.
"Whether 14 days, 14 months, or anywhere in between, such 'rules'remain contrivances to justify the most unethical kinds of science and to allow for the exploitation of our own vulnerable human offspring," said Tadeusz Pacholczyk, a neuroscientist and director of education at the National Catholic Bioethics Center in Philadelphia.
A single cell is removed from a human embryo to be used in generating embryonic stem cells for scientific research.Advanced Cell Technology via AP
Countries are free to ignore rules set by the society, but scientists for decades have generally abided by them. (In the U.S., there's no national law about the 14-day rule, though some states have their own regulations.)
Some cultures and religions believe that human life begins at conception, or that the human embryo carries a special status from conception onward. Other cultures believe that life starts later in fetal development, or even at birth.
Biologists routinely grow amphibian and mammal embryos in petri dishes, but human embryos are different.
Until about 14 days after conception, the human embryo looks likean undifferentiated blob of cells, which is one of the reasons the two week timeframemade sense, several scientists said.
Robin Lovell-Badge, who sits on the International Stem Cell Society committee that's considering overturning the rule, said scientists will take any changes seriously.
"We've stuck with that rule for over 30 years," he said.
Lovell-Badgefavors extending the limit, as long as the research is scientifically justified and has public support.
Not everyone in the scientific community shares this position.
"It's been a difficult part of the guidelines to get agreement on," Lovell-Badge said. "You have very wide-ranging views."
Some scientists argue there's a lot to be learned by pushing the 14-day rule out another two weeks.
Right now the second two weeks after fertilization is considered a "black box" because so little is known about it, said Insoo Hyun, a professor of bioethics atCase Western and Harvard universities. Heco-wrote a March 5 opinion piece arguing for a careful, stepwiseextension of the 14-day rule.
"You have to really make your case for it,"Hyun said."You have to explain what you want to do and why, have a very clear picture of where the next stopping point is."
Women generally don't know they're pregnant before 28 days, so historically, there has not been tissue from aborted or miscarried fetuses available for research.
The central nervous system, heart and other organs begin to develop during this crucial two-week period. The body plan is established. Cells that will become eggs and sperm start to form. Aspects of theplacenta are set up.
In many ways,days 14 through28 are the most interesting period of human development, Lovell-Badge said. "You can do a whole lot of incredibly valuable research," in that timeframe, he said.
And it's in that window that many things can go wrong in a pregnancy, such as miscarriage or abnormalities.
Perhaps there are treatments that could be developed to fix these problems, if they are better understood,Hyunsaid, just as pregnant women now take vitamin supplements to prevent spina bifida, in which the spine doesn't developproperly.
Do you think scientists should be allowed to grow embryos in a dish beyond 14 days? Share this story.
Share on Facebook
Developing embryos for another week "will thus illuminate this poorly understood period of our development and bring greater understanding of pregnancy loss and developmental disease,"saidMagdalenaZernicka-Goetz,theBritish scientist who developed the technique for growing human embryos for nearly two weeks.Zernicka-Goetz,author of a 2020 book on human development called "The Dance of Life,"would like to extend the 14-day rule out one week to 21 days.
"This will enable thescientiststo study a period of development that are highly susceptible to developmental failure, something that happens quite frequently in human pregnancy," she wrote in an email, stressing work should be closely regulated"to achieve these potential biomedical advances within an appropriate bi-ethical framework."
Despite their differences, most scientists seem to agreethere's no reason to push development past 28 days.
By onemonth after conception, embryonic tissue is easier to obtain and study and theorgans have formed, leaving fewer questions to answer.
"You wouldn't need to take them much beyond that point anyway," Lovell-Badgesaid.
Pacholczyk, of the Catholic Bioethics Center, said there's simply no justification for 14 days or any other time limit.
"Researchers have been feigning for a long time that the 14-day rule was somehow an ethical tenet grounded in biological facts while in reality it has been little more than a ceremonial 'line in the sand' and it should come as little surprise that they are now seeking to move that line beyond 14 days," he wrote in an email.
Even some who strongly supportscientific research are uncomfortable extending the 14-day rule.
HenryGreely, who directs the Stanford Center for Law and the Biosciences at Stanford University in California, saidthere should be a hard-stop endpointfor embryo research.
"Even though I do not personally give strong moral status to embryos, the idea of doing research on 18-day-oldhuman embryos is disturbing," said Greely, author of the new book "CRISPR People: The Science and Ethics of Editing Humans."
This sequence of images shows the development of embryos after correcting for a genetic error that would otherwise cause a type of inherited heart disease.OHSU
"I'd like to see an endpoint that had some rationale that would make it likely to stick," he said.
Growing an embryo in a lab dish instead of a woman's womb is necessarily different, Greely said, and may not represent a "real" embryo anyway.
"Does a 14-day embryo that is not implanted deep in a woman's uterus tell us anything meaningful about a 14-day embryo that is?" he asked.
Marcy Darnovsky, executive director of the Center for Genetics and Society, a nonprofit advocacy group,said efforts to overturn the 14-day rule are another example of scientific over-reach.
"There's a real problem with scientists who are jumping ahead of the public," she said.
Scientists should not be the ones who get to decide where society's moral boundaries lie,she and Hurlbut said.
"If moves are made to usurp these questions from wider society," Hurlbut said, "it's to the detriment of democracy and to the detriment of sciencecertainly in the long run, and probably in the short run."
Contact Karen Weintraub at kweintraub@usatoday.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
Published 10:13 am UTC May. 2, 2021 Updated 10:13 am UTC May. 2, 2021
- 5 potential benefits of exosome treatment - AZ Big Media - June 8th, 2021
- Orion and the Blood Service launch collaboration to develop new CAR T-cell cancer therapy - Yahoo Finance Australia - June 8th, 2021
- Improvements in the Treatment of Patients With MCL Over the Past Decade - Oncology Learning Network - June 8th, 2021
- Novo Nordisk partners with Heartseed on heart failure cell therapy - PMLiVE - June 8th, 2021
- Citius Pharmaceuticals to be Added to Russell 2000 Index - BioSpace - June 8th, 2021
- IN8bio Completes Treatment of First Cohort in Phase 1 Clinical Trial with Gamma Delta T-Cell Therapy in Patients with Newly Diagnosed Glioblastoma... - June 8th, 2021
- Regenerative medicine: moving next-gen treatments from lab to clinic - Pharmaceutical Technology - June 8th, 2021
- Global $30+ Billion Cell Therapy Bioprocessing Market to 2028: Market Opportunities in Automated Procedures to Produce Cell Therapies - PRNewswire - June 8th, 2021
- Global Stem Cell & Regenerative Medicine Market Report Forecast to 2027 3M Group Novartis AG Integra Gene Therapies The Manomet Current - The... - June 8th, 2021
- Novel CAR-T Cell Therapy Produces Early and Deep Responses in Certain Patients with Multiple Myeloma - Curetoday.com - June 8th, 2021
- BioRestorative Therapies to Present at the Emerging Growth Conference on June 9, 2021 - StreetInsider.com - June 8th, 2021
- Innovent Biologics and IASO Biotherapeutics to Present Updated Data from its Anti-BCMA CAR-T Therapy in Relapsed/Refractory Multiple Myeloma at... - June 8th, 2021
- High Rate of Response Noted in MCL and CLL With Cirmtuzumab Plus Ibrutinib - Cancer Network - June 8th, 2021
- Dr. Ghosh on the Role of Off-the-Shelf CAR T-Cell Therapy in Myeloma June - OncLive - June 8th, 2021
- Triplet Combo of Polatuzumab Vedotin, Rituximab and Lenalidomide Safe, Effective to Treat Relapsed/Refractory DLBCL - Cancer Network - June 8th, 2021
- Income, Education Affect Treatment and Survival in MDS - DocWire News - June 8th, 2021
- Polatuzumab With Rituximab and Lenalidomide Shown Safe and Effective for Relapsed/Refractory DLBCL - Targeted Oncology - June 8th, 2021
- Early Promise Observed With Lisaftoclax in Relapsed/Refractory CLL and Other Hematologic Malignancies - Targeted Oncology - June 8th, 2021
- Mustang Bio to Host Key Opinion Leader Webinar on MB-106 CD20-Targeted CAR T for - GlobeNewswire - June 8th, 2021
- FDA Lifts Hold on bluebird bio's Sickle Cell and Beta-Thalassemia Gene Therapies - BioSpace - June 8th, 2021
- Abecma Continues to Improve Survival in Heavily Pretreated Patients With Multiple Myeloma - Curetoday.com - June 8th, 2021
- HSCT-Sparing, Chemotherapy-Free Treatment of Ph+ ALL With Ponatinib/Blinatumomab Leads to 100% CR Rate - Cancer Network - June 8th, 2021
- Fate Therapeutics Highlights Positive Interim Data from its Phase 1 Study of FT516 in Combination with - GlobeNewswire - June 8th, 2021
- Action Taken by Governor Phil Scott on Legislation - June 7, 2021 - Office of Governor Phil Scott - June 8th, 2021
- Cancer research: New advances and innovations - Medical News Today - June 8th, 2021
- Naturally Treat & Heal The Cause of Pain with Regenerative Therapies - The Mountaineer - May 15th, 2021
- CAR T-Cell Therapy UCARTCS1A Shows Early Activity in Relapsed/Refractory Myeloma - OncLive - May 15th, 2021
- Rinri Therapeutics Secures Innovate UK Funding Grant for 3.2m Project to Advance its Novel Cell-Based Therapy to Restore Hearing Loss - PRNewswire - May 15th, 2021
- With $52 Million Series A, Appia Bio Anticipates a Bright Future in Cell Therapy - BioSpace - May 15th, 2021
- Genenta Phase I/II Glioblastoma Data at ASGCT Show Temferon Delivered Tumor-Focused Interferon ExpressionData presented at the 2021 American Society... - May 15th, 2021
- Safety and Efficacy of Consolidation Therapy with Ipilimumab Plus Nivolumab after Autologous Stem Cell Transplantation - DocWire News - May 15th, 2021
- Fascination with stem cell sensation leads to Fulbright scholarship - Monash University - May 15th, 2021
- Omeros' Narsoplimab Pivotal Trial Data to Be Shared as an Oral Presentation at the European Hematology Association Congress - Business Wire - May 15th, 2021
- Munshi Explains Staging, Prognosis, and Treatment for a Patient With Acute Graft-vs-Host-Disease - Targeted Oncology - May 15th, 2021
- KD-PACE Salvage Therapy for Aggressive Relapsed Refractory Multiple Myeloma, Plasma Cell Leukemia and Extramedullary Myeloma - DocWire News - May 15th, 2021
- Icy Microneedle Patch Delivers Cell Therapy, Then Melts - Freethink - May 15th, 2021
- FDA Responds to Creative Medical Technology Holdings Regarding Its ImmCelz IND for Stroke Treatment - BioSpace - May 15th, 2021
- Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market 2021 Type and End-use Industry 2026 Orange County Hair Restoration Center,... - May 15th, 2021
- Allogeneic Mesenchymal Stem Cell Segment Is Expected To Lead In the Global Rheumatoid Arthritis Stem Cell Therapy Market over the Forecast Period,... - May 15th, 2021
- Advanced Therapy Medicinal Products Market Size Worth $21.2 Billion By 2028: Grand View Research, Inc. - PRNewswire - May 15th, 2021
- New connection between metabolism and red blood cell development - Harvard Gazette - May 15th, 2021
- Heart attack recovery aided by injecting heart muscle cells that overexpress cyclin D2 - The Mix - May 15th, 2021
- Vertex and CRISPR Therapeutics to Present New Clinical Data - GlobeNewswire - May 15th, 2021
- Rocket Pharmaceuticals Presents Positive Clinical Data from Fanconi Anemia, Leukocyte Adhesion Deficiency-I, and Pyruvate Kinase Deficiency Programs... - May 15th, 2021
- Stem Cell Therapy Global Market Report 2021: COVID-19 Growth And Change To 2030 - Yahoo Finance - May 3rd, 2021
- Stem cell therapy for COPD: Cost, effectiveness, and more - Medical News Today - May 3rd, 2021
- Thomas Smeenk on Hemostemix's autologous stem cell therapy technology and why some call it 'the fountain of youth' - InvestorIntel - May 3rd, 2021
- Mesoblast says its stem cell treatment saved lives of severely ill COVID patients - Stockhead - May 3rd, 2021
- Antiviral T cells protected, viable as off-the-shelf treatment for painful complication stem cells - Microbioz India - May 3rd, 2021
- Investigating CAR T-Cell Therapy for Use in Different Disease Types - Targeted Oncology - May 3rd, 2021
- Hope, hype and exploitation the wild history of stem cell science - ABC News - May 3rd, 2021
- Brave New World is being reinvented with synthetic embryosand the right reasons - SYFY WIRE - May 3rd, 2021
- Stem Cell Therapy Market Trends Evaluation 2021 By Leading Players Updates, Consumer-Demand, Key Strategies, Consumption, Industry Development, Market... - May 3rd, 2021
- STEM NOLA Teams with Obatala Science & CellSpring to Expose Students to Careers and Medical Research at Biotech Startups - PRNewswire - May 3rd, 2021
- Breakthrough gene therapies in sight | UNC-Chapel Hill - UNC Chapell Hill - May 3rd, 2021
- FDA's Abecma Approval a 'Great Blessing' for Patients with Multiple Myeloma - Curetoday.com - May 3rd, 2021
- Enhanced inhibition of tumor growth using TRAIL-overexpressing adipose-derived stem cells in combination with the chemotherapeutic agent CPT-11 in... - May 3rd, 2021
- Global Stem Cell Therapy Market 2020-2027 Trends, industry vertical, along with the geography, delivering valuable insights | Reportspedia Clark... - May 3rd, 2021
- Rheumatoid Arthritis Stem Cell Therapy Market Report 2021 by Global Key Players, Types, Applications, Countries, Size, Forecast to 2027 Clark County... - May 3rd, 2021
- CRISPRoff Reversible Epigenome Editing Method Could Enable Safer, More Precise Therapeutics - GenomeWeb - May 3rd, 2021
- Cell Therapy Market To Expand At An expeditious Growth Rate From 2021-2027 | Thermo Fisher Scientific, Nanofiber Solutions, Advanced Biomatrix,... - May 3rd, 2021
- FTC continues to crack down on companies peddling fake COVID treatments and cures - HamletHub - May 3rd, 2021
- ThermoGenesis : The History of Cell and Gene Therapy - marketscreener.com - April 18th, 2021
- Russell Health Honored in Global Business Leaders Magazine's '20 Leading Companies of the Year 2021' - PRNewswire - April 18th, 2021
- Durable B-ALL Control With Allogeneic Transplant After CAR T-Cell Therapy - Cancer Therapy Advisor - April 18th, 2021
- CRISPR lauds easy scale-out of cell therapy - BioProcess Insider - BioProcess Insider - April 18th, 2021
- NeoProgen, Inc. Receives First Granted Patent for Method to Treat Cardiac Conditions using Neonatal Heart-derived Medicinal Signaling Cells (nMSCs)... - April 18th, 2021
- CRISPR gene therapy for sickle cell disease approved by the FDA - BioNews - April 18th, 2021
- Man's heart healed by stem cell therapy and love of an old flame - Leeds Live - April 18th, 2021
- Autologous Stem Cell Based Therapies Market Professional Report 2021 Witness Robust Expansion by 2026 SoccerNurds - SoccerNurds - April 18th, 2021
- Stem Cell Therapy Market Analysis 2021: Size, Share, Sales, Growth, Revenue, Type, Application & Forecast To 2027 SoccerNurds - SoccerNurds - April 18th, 2021
- Mastitis therapy explored | AG | kmaland.com - KMAland - April 18th, 2021
- CAR T-Cell Therapy Enters the Arena in Multiple Myeloma With Ongoing Research Ahead - OncLive - April 18th, 2021
- Leukemia Cutis: Symptoms and Treatment - Healthline - April 18th, 2021
- Stem Cell Therapy Market is Set to Witness Impressive Growth | Top Players Osiris Therapeutics, Inc. (US), MEDIPOST Co., Ltd. KSU | The Sentinel... - April 18th, 2021
- Global Stem Cell Therapy Market 2020 SWOT Analysis, Growth Rate, and Market Share By Type, Application and Global Forecast 2027 - Los Hijos de la... - April 18th, 2021
- Stem Cell Therapy Market Potential Growth, Size, Share, Demand and Analysis of Key Players Research Forecasts to 2025 - The Courier - March 8th, 2021
- Animal Stem Cell Therapy Market Size, Industry Analysis, Growth Factors, Trends, and Regional Forecast to 2027 - The Courier - March 8th, 2021
- Pericardial Injection Effective, Less Invasive Way to Get Regenerative Therapies to Heart - NC State News - March 8th, 2021
- Biomarkers Help Predict the Role of Chemotherapy in Biologic Aging - OncLive - March 8th, 2021