Editing Stem cell (section)

==Research==
{{Further|Consumer Watchdog vs. Wisconsin Alumni Research Foundation}}

Some of the fundamental [[patent]]s covering human embryonic stem cells are owned by the [[Wisconsin Alumni Research Foundation]] (WARF) – they are patents 5,843,780, 6,200,806, and 7,029,913 invented by [[James Thomson (cell biologist)|James A. Thomson]]. WARF does not enforce these patents against academic scientists, but does enforce them against companies.<ref name = "stemcellPatent">{{Cite web |title=How a University's Patents May Limit Stem-Cell Research |url=https://www.geneticsandsociety.org/article/how-universitys-patents-may-limit-stem-cell-research?id=1896 |access-date=2024-12-28 |language=en|publisher=[[The Wall Street Journal]]}}</ref>

In 2006, a request for the [[US Patent and Trademark Office]] (USPTO) to re-examine the three patents was filed by the Public Patent Foundation<ref>{{Cite web |title=Public Patent Foundation - GuideStar Profile |url=https://www.guidestar.org/profile/20-0236613 |access-date=2024-12-28 |website=www.guidestar.org}}</ref> on behalf of its client, the non-profit patent-watchdog group [[Consumer Watchdog]] (formerly the Foundation for Taxpayer and Consumer Rights).<ref name = "stemcellPatent"/>   In the re-examination process, which involves several rounds of discussion between the USPTO and the parties, the USPTO initially agreed with Consumer Watchdog and rejected all the claims in all three patents,<ref>{{Cite web |title=WARF Stem Cell Patents Knocked Down in Round One |url=https://patentbaristas.com/archives/2007/04/03/warf-stem-cell-patents-knocked-down-in-round-one/ |access-date=2024-12-28|first=Stephen |last=Jenei |publisher=Patent Baristas|date= April 3, 2007 }}</ref> however in response, WARF amended the claims of all three patents to make them more narrow, and in 2008 the USPTO found the amended claims in all three patents to be patentable. The decision on one of the patents (7,029,913) was appealable, while the decisions on the other two were not.<ref>{{Cite web |title=Ding! WARF Wins Round 2 As Stem Cell Patent Upheld |url=https://patentbaristas.com/archives/2008/03/03/ding-warf-wins-round-2-as-stem-cell-patent-upheld/ |access-date=2024-12-28|first=Stephen |last=Jenei |publisher=Patent Baristas|date= March 3, 2008 }}</ref><ref>{{Cite news |title=WARF Goes 3 for 3 on Patents |url=https://www.science.org/content/article/warf-goes-3-3-patents |access-date=2024-12-28 |language=en|authorlink=Constance Holden |first=Constance |last=Holden|publisher=Science Now|date=March 12, 2008 }}</ref> Consumer Watchdog appealed the granting of the '913 patent to the USPTO's Board of Patent Appeals and Interferences (BPAI) which granted the appeal, and in 2010 the BPAI decided that the amended claims of the '913 patent were not patentable.<ref>{{Cite web |last=McKeown |first=Scott |date=2010-05-10 |title=BPAI Rejects WARF Stem Cell Patent Claims in Inter Partes Reexamination Appeal |url=https://www.patentspostgrant.com/2010/05/bpai-rejects-warf-stem-cell-patent-claims-in-inter-partes-reexamination-appeal/ |access-date=2024-12-28 |website=Patents Post-Grant |language=en-US}}</ref> However, WARF was able to re-open prosecution of the case and did so, amending the claims of the '913 patent again to make them more narrow, and in January 2013 the amended claims were allowed.<ref>{{Cite web |title=The Foundation For Taxpayer & Consumer Rights, Requester And Appellant V. Patent Of Wisconsin Alumni Research Foundation, Appeal 2012-011693, Reexamination Control 95/000,154 Patent 7,029,913 |url=http://e-foia.uspto.gov/Foia/ReterivePdf?system=BPAI&flNm=fd2012011693-01-22-2013-1 |archive-url=http://web.archive.org/web/20130220112912/http://e-foia.uspto.gov/Foia/ReterivePdf?system=BPAI&flNm=fd2012011693-01-22-2013-1 |archive-date=2013-02-20 |access-date=2024-12-28 |website=e-foia.uspto.gov}}</ref>

In July 2013, Consumer Watchdog announced that it would appeal the decision to allow the claims of the '913 patent to the US [[Court of Appeals for the Federal Circuit]] (CAFC), the federal appeals court that hears patent cases.<ref>{{Cite web |date=2013-07-03 |title=Consumer Watchdog, PPF Seek Invalidation of WARF's Stem Cell Patent |url=https://www.genomeweb.com/archive/consumer-watchdog-ppf-seek-invalidation-warfs-stem-cell-patent |access-date=2024-12-28 |website=GenomeWeb |language=en}}</ref> At a hearing in December 2013, the CAFC raised the question of whether Consumer Watchdog had [[legal standing]] to appeal; the case could not proceed until that issue was resolved.<ref>Antoinette Konski for Personalized Medicine Bulletin. February 3, 2014 [http://www.personalizedmedicinebulletin.com/2014/02/03/u-s-government-and-uspto-urges-federal-circuit-to-dismiss-stem-cell-appeal/ U.S. Government and USPTO Urges Federal Circuit to Dismiss Stem Cell Appeal]</ref>

===Conditions===
[[File:Stem cell treatments.svg|thumb|upright=1.5|Diseases and conditions where stem cell treatment is being investigated]]
Diseases and conditions where stem cell treatment is being investigated include:
* [[Diabetes]]<ref name="nih" />
*[[Pattern hair loss|Androgenic Alopecia and hair loss]]<ref>{{Cite web|title=Treating Hair Loss with Stem Cell & PRP Therapy|url=https://stemcells.la/treating-hair-loss-with-stem-cell-prp-therapy/|date=2019-02-20|website=Stem Cells LA|language=en-US|access-date=2020-05-30}}</ref><ref>{{Cite journal|last1=Gentile|first1=Pietro|last2=Garcovich|first2=Simone|last3=Bielli|first3=Alessandra|last4=Scioli|first4=Maria Giovanna|last5=Orlandi|first5=Augusto|last6=Cervelli|first6=Valerio|date=November 2015|title=The Effect of Platelet-Rich Plasma in Hair Regrowth: A Randomized Placebo-Controlled Trial|journal=Stem Cells Translational Medicine|volume=4|issue=11|pages=1317–1323|doi=10.5966/sctm.2015-0107|issn=2157-6564|pmc=4622412|pmid=26400925}}</ref>
* [[Rheumatoid arthritis]]<ref name="nih" />
* [[Parkinson's disease]]<ref name="nih" />
* [[Alzheimer's disease]]<ref name="nih" />
* [[Respiratory disease]]<ref>{{cite journal |last1=Hynds |first1=R |title=Exploiting the potential of lung stem cells to develop pro-regenerative therapies |journal=Biology Open |date=2022 |volume=11 |issue=10 |doi=10.1242/bio.059423 |pmid=36239242 |pmc=9581519 |doi-access=free }}</ref>
* [[Osteoarthritis]]<ref name="nih">{{Cite web |title=Stemcells Redirection |url=http://stemcells.nih.gov/info/basics/pages/basics6.aspx |archive-url=http://web.archive.org/web/20180619214156/https://stemcells.nih.gov/info/basics/pages/basics6.aspx |archive-date=2018-06-19 |access-date=2024-12-28 |website=stemcells.nih.gov |year=2009}}</ref>
* [[Stroke]] and [[traumatic brain injury]] repair<ref name=Steinberg2000>{{cite news |last1=Steinberg |first1=Douglas |title=Stem Cells Tapped to Replenish Organs |url=https://www.the-scientist.com/research/stem-cells-tapped-to-replenish-organs-55310 |work=The Scientist Magazine |date=26 November 2000 }}</ref>
* [[Learning disability]] due to [[congenital disorder]]<ref>{{Cite web |date=2008-12-25 |title=Israeli scientists reverse brain birth defects using stem cells |url=https://www.israel21c.org/israeli-scientists-reverse-brain-birth-defects-using-stem-cells/ |access-date=2024-12-28 |website=ISRAEL21c |language=en-US}}</ref>
* [[Spinal cord injury]] repair<ref>{{cite journal | vauthors = Kang KS, Kim SW, Oh YH, Yu JW, Kim KY, Park HK, Song CH, Han H | title = A 37-year-old spinal cord-injured female patient, transplanted of multipotent stem cells from human UC blood, with improved sensory perception and mobility, both functionally and morphologically: a case study | journal = Cytotherapy | volume = 7 | issue = 4 | pages = 368–373 | year = 2005 | pmid = 16162459 | doi = 10.1080/14653240500238160 | s2cid = 33471639 }}</ref>
* [[Heart infarction]]<ref>{{cite journal | vauthors = Strauer BE, Schannwell CM, Brehm M | title = Therapeutic potentials of stem cells in cardiac diseases | journal = Minerva Cardioangiologica | volume = 57 | issue = 2 | pages = 249–267 | date = April 2009 | pmid = 19274033 }}</ref>
* Anti-[[cancer]] treatments<ref name=Steinberg2000/>
* [[Baldness]] reversal<ref>{{cite news |last1=DeNoon |first1=Daniel J. |title=Hair Cloning Nears Reality as Baldness Cure |url=https://www.webmd.com/skin-problems-and-treatments/hair-loss/news/20041104/hair-cloning-nears-reality-as-baldness-cure |work=WebMD |date=4 November 2004 }}</ref>
* Replace missing [[teeth]]<ref>{{cite journal | vauthors = Yen AH, Sharpe PT | title = Stem cells and tooth tissue engineering | journal = Cell and Tissue Research | volume = 331 | issue = 1 | pages = 359–372 | date = January 2008 | pmid = 17938970 | doi = 10.1007/s00441-007-0467-6 | s2cid = 23765276 }}</ref>
* Repair [[hearing]]<ref>{{cite magazine|url=https://www.newscientist.com/article/dn7003|title=Gene therapy is first deafness 'cure'|magazine=New Scientist|date=February 14, 2005}}</ref>
* Restore [[Visual system|vision]]<ref>{{cite news|url=http://news.bbc.co.uk/1/hi/england/southern_counties/4495419.stm|title= Stem cells used to restore vision|work=BBC News|date= 2005-04-28}}</ref> and repair damage to the [[cornea]]<ref>{{cite journal | vauthors = Hanson C, Hardarson T, Ellerström C, Nordberg M, Caisander G, Rao M, Hyllner J, Stenevi U | title = Transplantation of human embryonic stem cells onto a partially wounded human cornea in vitro | journal = Acta Ophthalmologica | volume = 91 | issue = 2 | pages = 127–130 | date = March 2013 | pmid = 22280565 | pmc = 3660785 | doi = 10.1111/j.1755-3768.2011.02358.x }}</ref>
* [[Amyotrophic lateral sclerosis]]<ref>{{cite journal | vauthors = Vastag B | title = Stem cells step closer to the clinic: paralysis partially reversed in rats with ALS-like disease | journal = JAMA | volume = 285 | issue = 13 | pages = 1691–1693 | date = April 2001 | pmid = 11277806 | doi = 10.1001/jama.285.13.1691 }}</ref>
* [[Crohn's disease]]<ref>{{cite journal |last1=Anderson |first1=Querida |title=Osiris Trumpets Its Adult Stem Cell Product |journal=Genetic Engineering and Biotechnology News |date=15 June 2008 |volume=28 |issue=12 |url=https://www.genengnews.com/magazine/94/osiris-trumpets-its-adult-stem-cell-product/ }}</ref>
* [[Wound healing]]<ref>{{cite journal |last1=Gurtner |first1=Geoffrey C. |last2=Callaghan |first2=Matthew J. |last3=Longaker |first3=Michael T. |title=Progress and Potential for Regenerative Medicine |journal=Annual Review of Medicine |date=February 2007 |volume=58 |issue=1 |pages=299–312 |doi=10.1146/annurev.med.58.082405.095329 |pmid=17076602 }}</ref>
* [[Male infertility]] due to absence of spermatogonial stem cells.<ref>{{cite book |vauthors=Hanna V, Gassei K, Orwig KE | chapter = Stem Cell Therapies for Male Infertility: Where Are We Now and Where Are We Going? | veditors = Carrell D, Schlegel P, Racowsky C, Gianaroli L | title = Biennial Review of Infertility | pages = 17–39 | year = 2015 | publisher = Springer | doi = 10.1007/978-3-319-17849-3_3 | isbn = 978-3-319-17849-3 }} Bone marrow transplantation is, as of 2009, the only established use of stem cells.</ref> In recent studies, scientists have found a way to solve this problem by reprogramming a cell and turning it into a spermatozoon. Other studies have proven the restoration of spermatogenesis by introducing human iPSC cells in mice testicles. This could mean the end of [[azoospermia]].<ref>{{cite journal | vauthors = Valli H, Phillips BT, Shetty G, Byrne JA, Clark AT, Meistrich ML, Orwig KE | title = Germline stem cells: toward the regeneration of spermatogenesis | journal = Fertility and Sterility | volume = 101 | issue = 1 | pages = 3–13 | date = January 2014 | pmid = 24314923 | pmc = 3880407 | doi = 10.1016/j.fertnstert.2013.10.052 }}</ref>
* [[Female infertility]]: oocytes made from embryonic stem cells. Scientists have found the ovarian stem cells, a rare type of cells (0.014%) found in the ovary. They could be used as a treatment not only for infertility, but also for premature ovarian insufficiency (POI).<ref>{{cite journal | vauthors = White YA, Woods DC, Takai Y, Ishihara O, Seki H, Tilly JL | title = Oocyte formation by mitotically active germ cells purified from ovaries of reproductive-age women | journal = Nature Medicine | volume = 18 | issue = 3 | pages = 413–421 | date = February 2012 | pmid = 22366948 | pmc = 3296965 | doi = 10.1038/nm.2669 }}</ref> New research posted in Science Direct suggests that ovarian follicles could be triggered to grow in the ovarian environment by using stem cells present in [[bone marrow]]. This study was conducted by infusing human bone marrow stem cells into immune-deficient mice to improve fertilization.<ref>{{Cite journal |last1=Herraiz |first1=Sonia |last2=Buigues |first2=Anna |last3=Díaz-García |first3=César |last4=Romeu |first4=Mónica |last5=Martínez |first5=Susana |last6=Gómez-Seguí |first6=Inés |last7=Simón |first7=Carlos |last8=Hsueh |first8=Aaron J. |last9=Pellicer |first9=Antonio |date=May 2018 |title=Fertility rescue and ovarian follicle growth promotion by bone marrow stem cell infusion |url=https://linkinghub.elsevier.com/retrieve/pii/S0015028218300049 |journal=Fertility and Sterility |volume=109 |issue=5 |pages=908–918.e2 |doi=10.1016/j.fertnstert.2018.01.004 |pmid=29576341 |issn=0015-0282}}</ref> Another study conducted using mice with damaged ovarian function from [[Chemotherapy|chemothearpy]] found that [[in vivo]] thearpy with bone marrow stem cells can heal the damaged ovaries.<ref>{{Cite journal |last1=Badawy |first1=Ahmed |last2=Sobh |first2=Mohamed A. |last3=Ahdy |first3=Mohamed |last4=Abdelhafez |first4=Mohamed Sayed |date=2017-06-15 |title=Bone marrow mesenchymal stem cell repair of cyclophosphamide-induced ovarian insufficiency in a mouse model |journal=International Journal of Women's Health |language=English |volume=9 |pages=441–447 |doi=10.2147/IJWH.S134074 |doi-access=free |pmc=5479293 |pmid=28670143}}</ref> Both of these studies are [[Proof of concept|proof-of-concept]] and need to be furthered tested, but they have the possibility improve fertility for individuals who have POI from chemothearpy treatment.   
* Critical Limb Ischemia<ref>{{Cite journal |last1=Liew |first1=Aaron |last2=O'Brien |first2=Timothy |date=2012-07-30 |title=Therapeutic potential for mesenchymal stem cell transplantation in critical limb ischemia |journal=Stem Cell Research & Therapy |volume=3 |issue=4 |pages=28 |doi=10.1186/scrt119 |issn=1757-6512 |pmc=3580466 |pmid=22846185 |doi-access=free }}</ref>

=== Production ===
Research is underway to develop various sources for stem cells.<ref name="pmid23131007">{{cite journal | vauthors = Bubela T, Li MD, Hafez M, Bieber M, Atkins H | title = Is belief larger than fact: expectations, optimism and reality for translational stem cell research | journal = BMC Medicine | volume = 10 | pages = 133 | date = November 2012 | pmid = 23131007 | pmc = 3520764 | doi = 10.1186/1741-7015-10-133 | author-link1 = Tania Bubela | doi-access = free }}</ref>

=== Organoids ===
Research is attempting to generating [[organoid]]s using stem cells, which would allow for further understanding of human development, [[organogenesis]], and modeling of human diseases.<ref name="pmid25033469">{{cite journal | vauthors = Ader M, Tanaka EM | title = Modeling human development in 3D culture | journal = Current Opinion in Cell Biology | volume = 31 | pages = 23–28 | date = December 2014 | pmid = 25033469 | doi = 10.1016/j.ceb.2014.06.013 }}</ref> Engineered ‘synthetic organizer’ (SO) cells can instruct stem cells to grow into specific tissues and organs. The program used native and synthetic [[Cell adhesion molecules|cell adhesion protein molecules]] (CAMs) that help make cells sticky. The organizer cells self-assembled around mouse ESCs. These cells were engineered to produce [[morphogens]] (signaling molecules) that direct cellular development based on their concentration. Delivered morphogens disperse, leaving higher concentrations closer to the source and lower concentrations further away. These gradients signal cells' ultimate roles, such as nerve, skin cell, or connective tissue. The engineered organizer cells were also fitted with a chemical switch that enabled the researchers to turn the delivery of cellular instructions on and off, as well as a ‘suicide switch’ for eliminating the cells when needed. SOs carry spatial and biochemical information,  allowing considerable discretion in organoid formation.<ref>{{Cite web |last=McClure |first=Paul |date=2024-12-27 |title=Stem cells 'instructed' to form specific tissues and organs |url=https://newatlas.com/medical/stem-cells-organizing-cell-morphogens/ |access-date=2024-12-28 |website=New Atlas |language=en-US}}</ref>

=== Risks ===
[[Hepatotoxicity]] and drug-induced liver injury account for a substantial number of failures of new drugs in development and market withdrawal, highlighting the need for screening assays such as stem cell-derived hepatocyte-like cells, that are capable of detecting toxicity early in the [[drug development]] process.<ref name="stem2012">{{cite journal |last1=Greenhough |first1=Sebastian |last2=Hay |first2=David C. |title=Stem Cell-Based Toxicity Screening: Recent Advances in Hepatocyte Generation |journal=Pharmaceutical Medicine |date=April 2012 |volume=26 |issue=2 |pages=85–89 |doi=10.1007/BF03256896 |s2cid=15893493 }}</ref>

=== Dormancy ===
In August 2021, researchers in the [[Princess Margaret Cancer Centre]] at the [[University Health Network]] published their discovery of a dormancy mechanism in key stem cells which could help develop cancer treatments in the future.<ref>{{cite journal |last1=García-Prat |first1=Laura |last2=Kaufmann |first2=Kerstin B. |last3=Schneiter |first3=Florin |last4=Voisin |first4=Veronique |last5=Murison |first5=Alex |last6=Chen |first6=Jocelyn |last7=Chan-Seng-Yue |first7=Michelle |last8=Gan |first8=Olga I. |last9=McLeod |first9=Jessica L. |last10=Smith |first10=Sabrina A. |last11=Shoong |first11=Michelle C. |last12=Parris |first12=Darrien |last13=Pan |first13=Kristele |last14=Zeng |first14=Andy G.X. |last15=Krivdova |first15=Gabriela |last16=Gupta |first16=Kinam |last17=Takayanagi |first17=Shin-Ichiro |last18=Wagenblast |first18=Elvin |last19=Wang |first19=Weijia |last20=Lupien |first20=Mathieu |last21=Schroeder |first21=Timm |last22=Xie |first22=Stephanie Z. |last23=Dick |first23=John E. |title=TFEB-mediated endolysosomal activity controls human hematopoietic stem cell fate |journal=Cell Stem Cell |date=August 2021 |volume=28 |issue=10 |pages=1838–1850.e10 |doi=10.1016/j.stem.2021.07.003 |pmid=34343492 |s2cid=236915618 |doi-access=free |hdl=20.500.11850/510219 |hdl-access=free }}</ref>