Fetal tissue has been used in biomedical research for decades, contributing to advances in vaccine development and HIV drug testing. Current research into macular degeneration, multiple sclerosis, spinal cord injuries, and Parkinsons could lead to therapies that could improve the lives of millions of patients. But new federal restrictions on the use of fetal tissue, which become effective Sept. 25, will halt some studies and have a crippling effect on others.
In June, the U.S. Department of Health and Human Services (HHS) announced new rules that discontinue research within the National Institutes of Health (NIH) that involves human fetal tissue from elective abortions and requires that NIH-funded research involving human fetal tissue that is conducted at academic health centers be subject to a lengthy approval process.
AAMCNews spoke with Lawrence S. B. Goldstein, PhD, distinguished professor at the University of California (UC), San Diego, School of Medicine and founder and former director of the Sanford Stem Cell Clinical Center at UC San Diego Health, about how scientists use fetal tissue and what the new restrictions mean for the future of biomedical research.
For what areas of biomedical research is the use of fetal tissue particularly important?
Cells derived from fetal tissue have been critical in vaccine development. Numerous vaccines have been developed using fetal cells developed by [renowned researcher] Leonard Hayflick and others who followed in his footsteps.
Fetal tissue is also vital to areas of stem cell research because it helps us prove that the cells we've made are actually the cell progenitors of the organs were trying to build or the structures within those organs were trying to build. So fetal tissue is the gold-standard comparison in a variety of areas that use stem cells to make cells or tissues for replacement or research.
Those are the two biggest areas. A third would be the use of so-called humanized mice, where fetal tissue is used to make mice that have completely human blood-forming and immune cell-forming tissues so that drugs can be tested against HIV, for example, or research can be done on a variety of hereditary blood diseases and immune diseases.
What makes fetal tissue unique?
Some have argued that it has better growth potential in culture. But I think the most valuable part is that fetal tissue provides very early organ tissue that can be used for research, so early kidney tissue, early brain tissue, or early immune-forming tissue.
When we use stem cells, sometimes we're not entirely sure we've made pure populations of cells or that we necessarily have made the right kind of cell, so getting at the so-called progenitors of different organs and tissues is vital.
What are some common misconceptions about fetal tissue?
There are two incorrect statements about fetal tissue research. The first is that we know enough about stem cells that appropriate alternatives to fetal tissue can be developed now. The fact is, stem cells can do a lot of things. But there's very clear evidence in the scientific literature and presented at scientific meetings that establish that stem cells are not yet at the point where they can completely replace fetal tissue. In fact, the development of all alternatives using stem cells will require fetal tissue to validate that stem cells have made the right cell types.
The second incorrect statement is that all of these vaccines could have been developed using nonhuman cells, such as monkey cells, and that's also just not true. One of the problems with the use of monkey cells, for example, that's emerged from reviews of the history is that they often carry viruses that are potentially toxic to humans, and the human cells seem to lack those viruses.
[Science magazine journalist] Meredith Wadman, MD, recently wrote a book about the history of vaccine development called The Vaccine Race: Science, Politics, and the Human Costs of Defeating Disease. It's really very clear that fetal tissue was vital to the development and the continued production of vital vaccines that have saved millions and millions of lives. So it's an incorrect statement to say, Oh, we didn't need fetal cells in the development of vaccines. That's also nonsense. The history is clear.
How has fetal tissue made your own research possible?
The best example comes not from my own lab but from work we've done in the Sanford Stem Cell Clinical Center. One of the clinical trials thats ongoing is the use of fetal spinal stem cells to treat spinal cord injury. These cells have provided striking results in rats for spinal cord injury, and they're now in phase one human clinical trials. And a few of the patients seem to be doing better.
This is remarkable because spinal cord injury is an injury for which there's almost no effective treatment, and is unfortunately common, and its victims suffer terribly during their lives. We need more clinical trial data to really ascertain what's going on. We have to continue using these fetal cells in spinal cord injury victims to see if we can truly develop a therapy. But the results are very promising in the early stages.
Which aspects of these new restrictions are going to put the greatest burden on researchers?
One of the big problems is that a very long detailed justification for fetal tissue needs to be provided as part of the research strategy part of the application and NIH limits the number of pages you can have in that part of the application. Not only do you have to provide a lengthy justification for the use of fetal tissue ... it [also] crowds out a lot of the actual scientific part of the application.
A second potential problem is, if you have an existing [NIH Research Project Grant], and you make a discovery that requires some simple experiment with fetal tissue, you can't just go ahead and do it with the NIH funds. You have to write a completely new grant application that needs to go through competitive review and then the HHS ethics review board ... before you can do what is a simple experiment. It will slow down the progress of science in areas that may unexpectedly and appropriately require the use of fetal tissue for some straightforward experiments.
The third problem is the grants will all be exposed to duplicate review in a sense. [A grant will go to] the initial review group, which will review the fetal tissue justification and the science. Then it'll go to the NIH Council. This is all standard so far. But then it goes to the ethics review board of HHS, which in its current description, reviews not only the ethics, but also reviews the scientific justification again. Its completely redundant and a waste of time and it's not going to gain any additional quality of review of the science.
What do you foresee as the impact of these restrictions on early career scientists?
There's been some discussion of whether or not trainees supported by NIH training grants can participate in fetal tissue research. I'd say that the current situation is that it's murky. Many of us think that the way NIH has described which kinds of grants can use fetal tissue precludes trainees, such as graduate students and postdocs. NIH has countered, but I don't think the situation is so clear given how it's written.
If I were an investigator with a graduate student on an NIH training grant, I sure wouldn't let them work with fetal tissue, given how unclear the rules are and concerns about being audited and told that we did something inappropriate. That's not something I would be prepared to risk. We effectively preclude trainees supported by NIH training grants or research fellowships from participating in fetal tissue research and learning how to do it appropriately from their mentors.
Why should the academic medicine community be concerned about these new restrictions?
A very important goal of biomedical research is to develop new medical therapies as rapidly as possible for patients who suffer from terrible diseases. When we place these restrictions on important areas of research, we slow down the hunt for understanding and the development of new therapies for the patients of physicians, both in academic health centers and out in the regular community.
This interview has been edited for clarity and length.
- Asia Pacific Cell Therapy Instruments Market Forecast to 2027 - Covid-19 Impact and Regional Analysis - By Product ; Cell Type ; Process ; End User,... - November 27th, 2020
- Global Animal Stem Cell Therapy Market Research Report by Size, Data, Developments, Global Demand, In-Depth Analysis and Forecast 2020 to 2025 |... - November 27th, 2020
- Europe Cell Therapy Instruments Market Forecast to 2027 - Covid-19 Impact and Regional Analysis - By Product ; Cell Type ; Process ; End User, and... - November 27th, 2020
- Scaffold Technology Market Research Report by Product, by Application, by End-User - Global Forecast to 2025 - Cumulative Impact of COVID-19 -... - November 27th, 2020
- The Thorough Analysis Of The Global Stem Cell Media market Research During COVID-19 Health Crisis - The Courier - November 27th, 2020
- Autism genes affect development of neurons and glia - Spectrum - November 27th, 2020
- Global Live Cell Imaging Market Report 2020-2025: Market Size is Projected to Reach USD 2.8 Billion by 2025 from USD 1.8 Billion in 2020 - PRNewswire - November 27th, 2020
- North America Cell Therapy Instruments Market Forecast to 2027 - COVID-19 Impact and Regional Analysis By Product ; Cell Type ; Process ; End User,... - November 27th, 2020
- Post-doctoral Fellow in Computational Stem Cell Biology job with THE UNIVERSITY OF HONG KONG | 234737 - Times Higher Education (THE) - November 27th, 2020
- Circulating Tumor Cells and Cancer Stem Cells Market Research Report 2020 with Manufacturing Process Analysis and Market Concentration Rate till 2026... - November 27th, 2020
- Analyzing Impacts of Covid-19 on Global Cell Culture Media Market Effects, Aftermath and Forecast To 2025 - The Courier - November 27th, 2020
- Accretion: Current and Future Business Analysis in Cell Expansion Market - PharmiWeb.com - November 27th, 2020
- Adipose Tissue-Derived Stem Cells (ADSCS) Market Expected to Witness High Growth over the Forecast 2027 - Cheshire Media - November 27th, 2020
- Stem Cell Market to Witness a Pronounce Growth During (2020-2026) Cheshire Media - Cheshire Media - November 27th, 2020
- Demand with COVID-19 impact analysis on Cell Expansion Market - The Courier - November 27th, 2020
- Approval of Phase I/II Clinical Trial of ATG-016 (Eltanexor), a Second Generation Selective Inhibitor of Nuclear Export (SINE), in Mainland China for... - November 27th, 2020
- Researchers grow first plant-based gel to help organoid development for biomedical applications - Microbioz India - November 27th, 2020
- California's stem cell research agency looks to the future - Bond Buyer - November 25th, 2020
- Unexpected discovery about stem cell immortality study - News - The University of Sydney - November 25th, 2020
- Breakthroughs in Stem Cell Based Treatment of Heart Disease - The Connecticut College Voice - November 25th, 2020
- Mount Sinai Cardiologist Awarded $2.9 Million NIH Grant to Advance Work with Stem Cells and Heart Repair after Heart Attack - Cath Lab Digest - November 25th, 2020
- Stem Cell Therapy Global Market Report 2020-30: Covid 19 Growth and Change - Yahoo Finance UK - November 25th, 2020
- Global Cell Harvesting Market to Reach US$381,4 Million by the Year 2027 - PRNewswire - November 25th, 2020
- Middle East & Africa Cell Therapy Instruments Market Forecast to 2027 - COVID-19 Impact and Regional Analysis By Product ; Cell Type ; Process ;... - November 25th, 2020
- Global Stem Cell Banking Market to Get Expansion admist COVID 19, Scope With Advanced Technologies Top Key Players and Forecast 2020-2027 - The... - November 25th, 2020
- New study on CRISPR: the stake of unintended consequences in embryos - BioNews - November 25th, 2020
- The Stem Cell Characterization and Analysis Tools Market to grow incomparably in the next decade - The Market Feed - November 25th, 2020
- New solution to kill coronavirus on common surfaces in seconds - University of California - November 25th, 2020
- Agricultural Equipment Market to Witness Robust Expansion Throughout the Forecast Period 2027 - re:Jerusalem - November 20th, 2020
- Animal Stem Cell Therapy Market Projected to Witness Vigorous Expansion by 2027 - re:Jerusalem - November 12th, 2020
- The Canine Stem Cell Therapy Market To Move Away From Insipidness, Reach US$ 218.2 Mn - PRnews Leader - November 12th, 2020
- Rheumatoid Arthritis Stem Cell Therapy Market to Ride on Increased Prevalence of Rheumatoid Arthritis - TMR Research Blog - November 12th, 2020
- Stem Cell Therapy Market Growth Analysis 2020 By Industry Top Manufacturers, Business Opportunities, Industry Growth, Size, Gross Margin, Regional... - November 12th, 2020
- Stem Cell Media Market 2020 Industry Analysis and Trends Forecast to 2026 Thermo Fisher, CellGenix, Lonza, STEMCELL Technologies, Corning - The Think... - November 12th, 2020
- Autologous Stem Cell and Non-Stem Cell Based Therapies Market is Projected to Grow Massively in Near Future - The Daily Philadelphian - November 12th, 2020
- Global Live Cell Imaging Markets, 2020-2025 - Growing Adoption of High-Content Screening Techniques in Drug Discovery - Yahoo Finance UK - November 12th, 2020
- GLOBAL STEM CELL MARKET FORECAST 2021-2028 - GlobeNewswire - November 12th, 2020
- Flow Cytometry Market Is Expected to Generate Revenue of US$ 11.3 billion by 2030, Globally - GlobeNewswire - November 12th, 2020
- Stem Cell Therapy Market 2020 to 2025: Business Development Strategies and Top Manufacturers Analysis : Anterogen Co., Ltd. (South Korea), MEDIPOST... - November 12th, 2020
- ADC Therapeutics Reports Third Quarter 2020 Financial Results and Provides Recent Business Highlights - BioSpace - November 12th, 2020
- Stem Cell Characterization and Analysis Tool Market Size Analysis: Growth Factors, Share by Regional Production, Revenue and Regional Trends with Key... - November 12th, 2020
- Forma Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update - Galveston County Daily News - November 12th, 2020
- Adipose Tissue-Derived Stem Cells (ADSCS) Market Expected to Witness High Growth over the Forecast 2027 - BCFocus - November 12th, 2020
- Marker Therapeutics Reports Third Quarter 2020 Operating and Financial Results - PRNewswire - November 12th, 2020
- CODA Biotherapeutics Receives Grant from the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health... - November 12th, 2020
- Brain Development and Disorder Research Receives $1.5 Million NSF Boost - USC Viterbi School of Engineering - November 7th, 2020
- Many Initiatives Still Too Close to Call in California - Courthouse News Service - November 7th, 2020
- Election 2020: Californias ballot initiative system isnt working. - Vox.com - November 7th, 2020
- Stem Cell Therapy Market is estimated to be worth USD 8.5 Billion by 2030 - PRnews Leader - November 5th, 2020
- Cancer Stem Cell Therapeutics Market Outlooks 2020: Size, Cost Structures, Growth rate and Industry Analysis to 2027 - Eurowire - November 5th, 2020
- Biologics Safety Testing Market Research Report by Test Type, by Application - Global Forecast to 2025 - Cumulative Impact of COVID-19 - Yahoo Finance... - November 5th, 2020
- Global Regenerative Medicine Market (2020 to 2025) - Industry Trends, Share, Size, Growth, Opportunity and Forecast - ResearchAndMarkets.com -... - November 5th, 2020
- Stem Cell Media Market Projected to Witness Vigorous Expansion by 2027 - The Think Curiouser - November 5th, 2020
- Cell Isolation Market Research and Analysis by Expert: import/export details, Cost Structures and statistics till 2027 - KYT24 - November 5th, 2020
- MorphoSys to Present Data on Tafasitamab at the ASH Virtual Annual Meeting and Exposition - PharmiWeb.com - November 5th, 2020
- The Many Model Systems of COVID-19 - The Scientist - November 5th, 2020
- Soybean Trypsin Inhibitor Market Brief Analysis and Application, Growth by 2026 | Biological Industries, Thermo Fisher Scientific, Sigma-Aldrich... - November 5th, 2020
- Cell and Tissue Culture Supplies Market Analysis with Market Size, Industry Share, trends and Forecast to 2026 - The Think Curiouser - November 5th, 2020
- Voters asked to approve $5.5 billion for stem cell research - Madison.com - November 3rd, 2020
- A Review of Stem Cell-Based Therapies for Parkinson Disease - AJMC.com Managed Markets Network - November 3rd, 2020
- 10 health and science-focused races to watch on election night - STAT - November 3rd, 2020
- Animal Stem Cell Therapy Market 2020, Global Research Analysis Report Growth at CAGR Value, Industry Share, Key Company Profiles, Type, Applications,... - November 3rd, 2020
- Stem Cell Therapy Market To Exceed Revenues Worth US$ By The End Of 2020 2027 - Eurowire - November 3rd, 2020
- Stem Cell Banking Market Research Report 2020 By Segmentations, Key Company Profiles and Demand Forecasts to 2026 - Aerospace Journal - November 3rd, 2020
- Stem Cell Media Market Analysis And Demand With Forecast Overview To 2027 - Aerospace Journal - November 3rd, 2020
- Stem Cell Characterization and Analysis Tool Market : By Component, by Application, by Component Mode, and By Region Global Forecast up to 2026 -... - November 3rd, 2020
- Impact of COVID-19 on Plant Stem Cell For Cosmetics Market Overview with Detailed Analysis, Competitive Landscape & Forecast To 2026 - Eurowire - November 3rd, 2020
- 2020 Election Tracker: All The State Ballot Healthcare Initiatives - Forbes - November 3rd, 2020
- California Proposition 14 is about pikuach nefesh heres why - Forward - November 3rd, 2020
- Retinal Disorders Treatment Market: Advancements in Gene-therapy and Stem-cell Therapy to Bolster Market Growth - BioSpace - November 3rd, 2020
- Stem Cell Alopecia Treatment Market Insights and Development Trends from 2020-2027 - Aerospace Journal - November 3rd, 2020
- Global Stem Cell Therapy Market 2020 Research on Import-Export Details, Business Standards and Forecast to 2025 - PRnews Leader - November 3rd, 2020
- Canine Stem Cell Therapy Market Shows Expected Trend to Guide from 2020-2026 with Growth Analysis by Manufacturers, Regions, Type and Application -... - November 3rd, 2020
- Survival Benefit of GVHD in MDS Is Limited to Specific Patient Subgroup - Cancer Therapy Advisor - November 3rd, 2020
- Orchard Therapeutics Reviews Recent Portfolio Progress and Reports Third Quarter 2020 Financial Results - GlobeNewswire - November 3rd, 2020
- Meat-Tech 3D Ltd. Announces Successful $7 Million Funding Round led by Psagot Provident Funds and other leading institutional investors - PRNewswire - November 3rd, 2020
- Hematopoietic Stem Cells Transplantation (HSCT) Market Size 2020 Global Industry Trends, Future Growth, Regional Overview, Market Share, Revenue, and... - November 3rd, 2020
- Stem Cell Assay 2020 GLOBAL OUTLOOK, RESEARCH, TRENDS AND FORECAST TO 2025 - The Think Curiouser - November 3rd, 2020
- Cell Isolation Market report delivering growth analysis with key trends top companies and forecast 2027 - KYT24 - November 3rd, 2020
- Cancer Stem Cells Market 2020 By Business Opportunity, Innovations, Applications, Upcoming-Trends, Growth-Analysis, Demand-Insight, Segmentation,... - November 3rd, 2020