stem cell research news: volume 3, no. 19

8/14/2019 Stem Cell Research News: Volume 3, No. 19.

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December 1, 2001

Osiris Clears Final Patent Hurdle

for MSCs..................................1

Bush Creates Bioethics Council.4

ACT Creates First Cloned Human

Embryo.....................................6

Chinese Scientists Duplicate Gas-trointestinal Organs by Culturing

Stem Cells In Vitro ...................7

News Briefs ..... ......................... 8

Osir is Clears F inal Patent H urdle for Use of

Allogeneic Adult Mesenchymal Stem Cel ls

Company Says MSCs Are Plentiful, and Avoid Rejection by Im-

mune Systems

Osiris Therapeutics, Inc. (Baltimore, Md.) said it has cleared thefinal paperwork hurdle before receiving a U.S. patent coveringthe use of allogeneic human mesenchymal stem cells (MSC) in the re-

generation of a variety of connective tissues, including bone, heart

muscle, and cartilage.

Osiris believes the use of the donor-derived off-the-shelf

product for all clinical indications could make MSC-based cellular

therapies a feasible and cost-effective treatment for acute injuries as

well as for chronic diseases.

The only thing left is to print the patent up, Ken Moseley,

vice president for patents and business development, told SCR News in

an interview. The final patent award could come as early as a monthfrom now, he said.

The application protects the use of MSCs for the growth or

repair of all connective tissues, including bone, cartilage, muscle,

stroma, fat and other tissues. The MSCs may be administered systemi-

cally, locally or in a carrier. The cells may further be gene modified to

express genetic material of interest, according to the company.

Its really important, Moseley said. Weve shown that we

can use these cells in a fully allogeneic, fully mismatched, off-the-

shelf manner to avoid a lot of the problems that cell therapies in the

past have had.

These problems include high production costs, an inability to

address acute care indications, restrictions on the donor source based

on health or age and numerous logistical complexities.

One of the biggest problems is cost, he noted. Well see a re-

duction in cost of around twenty times if were able to use off-the-

shelf cells instead of a single production lot of autologous cells from

a patient.

In This Issue ... Tren d s in Brief...

Editorial Mission:

Stem Cell Research Newsis notaffiliated in any way with any advocacy,

trade, research or governmental organiza-

tion. We are dedicated to providing inde-

pendent, authoritative, up-to-the-minute,objective reportingon all facets of human

embryo and stem cell research. Informa-

tion contained in this newsletter is be-

lieved to be accurate and reliable at the

time of publication.

2001 by DataTrends Publications, Inc.

Whos Who in Stem Cell Research

Fall 2001 Edition

Updated, revised directory of researchers,

companies, etc. involved in stem cell re-

search. Mailing addresses, e-mail ad-

dresses, phone/fax, etc. Only $$95 for

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Funding

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In the future, after clinical trials and FDA

approval, Moseley said, off-the-shelf allogeneic

MSCs would be readily available to use in acute

care situations, such as treatment of a heart attack.

One would have the cells there in the

emergency room or in the lab for use in a heart at-tack patient, or in someone who has had a signifi-

cant bone break, Moseley said. So, its really a

big, big deal in overcoming a lot of the problems

with cell therapy.

MSCs Not Recognized by Immune System

The importance of Osiriss findings is twofold:

MSCs are easily produced and therefore abundant,

and they are not rejected by an organisms im-

mune system after transplantation.Rejection is a major problem in tissue

transplants. Typically, if you put cells from one

person into another person, or an organ such as

the heart, theres rejection, Moseley said. Pa-

tients are given immunosuppressive drugs to pre-

vent rejection.But MSCs somehow evade recognition by

cells of the immune system, then stably engraft

and differentiate into functional tissues. This all

happens without the need for drugs to suppress

the immune system, even when transplanted from

one species to another.

Osiris uses fully mismatched MSCs in its

preclinical models to demonstrate the lack of im-

munogenicity in bone repair in canines and ba-

boons, cardiac repair in swine and rats and menis-

cal regeneration in goats. Osiris has also shownthat allogeneic MSCs may be delivered in multiple

doses, from the same or different donors, without

immune recognition.

The company has put human MSCs into

sheep and rats and found that they engraft and dif-

ferentiate.

Abundant Supply of M SCs

The Osiris business model is based on the donor-

derived, off-the-shelf adult stem cell product.The company combines the allogeneic discovery

with its proprietary scalable closed system MSC

manufacturing process and cryopreservation for

simple product storage for greater than one year.

That allows immediate availability at the physi-

cian's site.

Its important to note that these MSCs

(Continued on page 3)

December 1, 2001Stem Cell Research News

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Culture trays containing human embryonic stem cells. Photo by

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are truly stem cells, Moseley said. They can re-

produce quite a bit from themselves, so we can

produce billions of cells from a given donation.

The same base MSC product is formulated

for different indications and delivered by infusion,

injection or by implantation on structural matricesto the site of the damaged tissue. This permits

substantial development, manufacturing and regu-

latory efficiencies.

Clinical trials are ongoing in the United

States and in Europe with MSCs for bone marrow

and peripheral blood stem cell transplantation sup-

port and in the United States for bone regenera-

tion.

Moseley said the company expects to

launch Phase I clinical trials in early 2002 for car-

diac regeneration post myocardial infarction andfor meniscal (knee) repair. The company is negoti-

ating with potential trial sites right now.

The purpose of the trials will be to investi-

gate the safety and utility of off-the-shelf MSCs.

Osiris has 27 U.S. patents, as well as sev-

eral allowed and pending applications.

The companys patents include the human

MSC itself from any starting material, gene-

modified MSCs, therapeutic methods, ex vivo dif-

ferentiation compositions and methods, produc-

tion and assay reagents.Osiris is also developing adult MSCs as a

delivery platform for gene therapy.

Contact: Ken Moseley, JD, 410-522-

5005, ext. 342, http://www.osiristx.com.

Bush Creates Panel to Study Stem

Cell Research, Other Bioethics

I ssues

Will Study of Fertility Issues Have a NegativeImpact on Stem Cell Research?

President Bush on November 28 issued an exec-utive order creating an 18-member bioethicscommittee to study and advise the president on

bioethical issues that may emerge as a conse-

quence of advances in biomedical science and

technology.

(Continued from page 2)

Stem Cell Research News December 1, 2001

Dean Clancy, a conservative policy advisor

in Congress, will serve as the first executive direc-

tor of the new national council.

Besides studying stem cell research, the

panel will examine the ethics of fertility and repro-

ductive science. And some experts are worried

this may have a negative impact on human embry-onic stem cell research down the road.

The new Presidents Council on Bioethics,

which will have only a two-year life span, is em-

powered to study a broad array of biomedical

fields, including embryo and stem cell research,

assisted reproduction, cloning, uses of knowl-

edge and techniques derived from human genetics

or the neurosciences, and end of life issues,

which primarily means euthanasia or mercy

killing.

Perhaps most surprising is the fact that thepanel will look at assisted reproduction, a term

that encompasses donor insemination, in vitro fer-

tilization and other reproductive therapies and

technologies.

In vitro fertilization is used to help women

become pregnant. It is a long-established medical

procedure in the U.S. and around the world.

Thousands of American women with fertility

problems attempt to conceive by artificial repro-

duction every year.

The professional organization that repre-sents fertility specialists, the American Society for

Reproductive Medicine, was founded in 1944 and

has members in all 50 states and 100 countries.

The ASRM has recorded more than

100,000 U.S. births 250,000 worldwide as

the result of in vitro fertilization since the proce-

dure produced the world's first test-tube baby in

England in 1978.

Pres. Bush named University of Chicago

bioethicist Dr. Leon R. Kass to chair the council.

None of the other 18 members have been desig-

nated. The president will name ethicists, scientists,

doctors, lawyers and theologians to the council

over the next few weeks, the White House said.

Kass is an outspoken opponent of human

cloning, whether therapeutic or reproductive. He

testified before the House Energy and Commerce



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Subcommittee on Health hearing on human

cloning in June 2001.

According to reports, Kass once opposed

in vitro fertilization, but reversed his position. His

current worry is that fertility clinics may be prac-

ticing some form of cloning.It is troubling because Leon Kass is the

chair, and I would rather they not talk about IVF

at all, ASRM spokesman SeanTipton told the As-

sociated Press. At least they're only a study com-

mission and there's no clear-and-present danger

here. But we are very concerned about what the

makeup of the rest of the panel will look like.

Impact on Stem Cell Research

President Bush said he would create a bioethicscommission when he announced his decision on

federal funding of human embryonic stem cell re-

search back in August. But he gave no hint at the

time that the study group would tackle such a

broad array of bioethical issues.

The study of fertility and assisted repro-

duction issues could have a negative impact on

stem cell research, according to some experts.

Stem cell research scientists have always

maintained that they should be allowed to experi-

ment with human embryos because theyre de-stroyed anyway when couples and clinics no

longer need them.

Embryonic stem cell research requires

embryos, said one observer, a research scientist

who asked anonymity. Currently, unused em-

bryos created for use in fertility procedures in fer-

tility clinics are the source of stem cells. These un-

used embryos have been, and continue to be, rou-

tinely discarded by the clinics, unless they are do-

nated by couples for research. A huge ethical issue

here, so far hardly discussed at all, is: Should

these embryos be destroyed at all? You bet Dr.

Kass is going to take a close look at that issue.

To really clamp down on embryo re-

search, the scientist suggested, you clamp down

on the source of the embryos. I can see the panel

strongly suggesting that something be done about

excess embryos. But I have no idea what that

(Continued from page 3) something might be.

Dean Clancy

The new executive director, Dean Clancy, will

oversee the administrative functions of the coun-

cil. Clancy, 37, previously served as a senior pol-icy advisor for Rep. Dick Armey of Texas, spe-

cializing in health policy, Medicare, Social Secu-

rity, bioethical issues, and other topics. Before

joining Rep. Armey's staff in 1993, he served as a

speechwriter for Housing and Urban Development

Secretary Jack Kemp and as a staff writer for Vice

President Dan Quayle.

Council s M ission

Other tasks the president assigned the new councilinclude:

Undertaking fundamental inquiry into the hu-

man and moral significance of developments in

biomedical and behavioral science and technol-

ogy;

Exploring specific ethical and policy questions

related to these developments;

Providing a forum for a national discussion ofbioethical issues;

Facilitating a greater understanding of bioethi-

cal issues; and

Exploring possibilities for useful international

collaboration on bioethical issues.

The council will also have the power to study broader

ethical and social issues not tied to a specific technol-

ogy. These include protection of human subjects inresearch, appropriate uses of biomedical technologies,

the moral implications of biomedical technologies, and

the consequences of limiting scientific research, ac-

cording to the executive order.

The council is not required to form a single

consensus opinion to present to the president on any of

these issues. It may offer a variety of views on any(Continued on page 5)



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given topic.

The council may conduct inquiries, hold hear-

ings, and establish subcommittees, as necessary.

Contact:Dr. Leon Kass, 773-702-8571, http:/

/www.uchicago.edu

Company Creates F irst Cloned

Human Embryo

Advanced Cell Technology, Inc. (Worcester, Mass.)on November 25 announced that it had cloned ahuman embryo in a scientific advance whose purpose is

not to create a human being but to use the embryo as a

source of stem cells that wont be rejected by patients

immune systems during therapeutic transplantation.

The company published its research on human

somatic cell nuclear transfer and parthenogenesis in the

November 25 issue of theJournal of Regenerative

Medicine, noting that it had provided the first proof

that reprogrammed human cells can supply tissue for

transplantation.

Human embryonic stem (ES) cells, and other

cells derived from the inner cell mass of the preimplan-

tation embryo are totipotent, i.e., capable of forming

any cell or tissue in the human body. While numerous

human ES cell lines are now in existence, they are of

little value in human transplantation, as they would be

rejected by a patient as foreign.

Human therapeutic cloning has the potential tosolve this problem by providing cells that are an exact

genetic match for the patient.

Two Ways to Manufacture the Cell s

The companys paper reports preliminary studies on

two ways to make such cells. The first method is

parthenogenesis. In this technique an egg cell is acti-

vated without being fertilized by a sperm cell. A patient

in need of a particular cell or tissue type provides the

egg cell, the activated egg cell forms a preimplantation

embryo, and the resulting stem cells are differentiated

into the type of tissue the patient needs. The paper re-

ports success in activating egg cells in this manner to

form many-celled embryos resembling blastocysts. The

paper does not report data on stem cell isolation.

In a second series of studies, the company per-

formed somatic cell nuclear transfer (cloning) to form

preimplantation embryos. In this instance, human egg

cells were prepared by removing their DNA and adding

(Continued from page 4) the DNA from a human somatic (body) cell. The paper

reports that the somatic nuclei showed evidence of re-

programming to an embryonic state as evidenced by

pronuclear development (a type of nucleus observed

only in the fertilized egg) and by early embryonic de-

velopment to the six-cell stage. Again, the company did

not report on stem cell isolation.

Our preliminary results add to the weight ofevidence that human cell reprogramming is possible,

said Jose B. Cibelli, Ph.D., D.VM., vice president of

Research at ACT and the first author of the report.

We understand that these are early and preliminary

results, but given the importance of this emerging field

of medicine we decided to publish our results now.

The companys goal in applying cloning to hu-

man medicine is to create stem cells capable of differ-

entiating into a variety of cells, such as heart cells, neu-

rons, blood cells or islets for transplant therapies.

These are exciting preliminary results, said Robert P.Lanza, M.D., vice president of medical and scientific

development at ACT and an author of the paper. This

work sets the stage for human therapeutic cloning as a

potentially limitless source of immune-compatible cells

for tissue engineering and transplantation medicine.

Our intention is not to create cloned human beings, but

rather to make lifesaving therapies for a wide range of

human disease conditions, including diabetes, strokes,

cancer, AIDS, and neurodegenerative disorders such as

Parkinsons and Alzheimers disease.

Nevertheless, U.S. lawmakers viewed the dis-

covery with skepticism. Federal law prohibits the useof taxpayer money for the cloning of human beings but

Advanced Cell Technologies is a privately funded com-

pany and can do as it pleases.

Noting that he didnt quite understand what

ACT had accomplished, Senate Majority Leader Tom

Daschle still called the study disconcerting on Fox

News Sunday. I think it's going in the wrong direc-

tion.

I believe it will be a big debate, but at the end

of the day I don't think we're going to let the cloning of

human embryos go on, Alabama Sen. Richard Shelby,

a Republican, told NBC's Meet the Press.

Vermont Sen. Patrick Leahy agreed. I find it

very, very troubling and I think most of the Congress

would, Leahy, a Democrat, told NBC.

Congress has moved to outlaw all human cloning. A

proposed new law is under consideration by the Senate.

Scientifically, biologically, the entities we are

creating are not individuals. They're only cellular life.




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They're not human life, Michael West, chief executive

officer of ACT, told NBC's Meet the Press.

Enormous Potential

Human therapeutic cloning could be used for a host of

age-related diseases, said Michael D. West, Ph.D. thecompanys CEO and an author of the paper, if the hu-

man cells behave as animal cells have in previous stud-

ies, we may have found a means of rebuilding the lifes-

pan of cells at the same time. This would allow us to

supply young cells of any kind, identical to the patient,

that could be used to address the tidal wave of age-

related disease that will accompany the aging of the

population.

Researchers from Advanced Cell Technology

collaborated with scientists from Duncan Holly

Biomedical of Somerville, Massachusetts on the paper.The other authors are Kerrianne Cunniff of ACT, and

Ann A. Kiessling and Charlotte Richards.

Contact:Dr. Michael D. West, 508-756-1212,

http://www.advancedcell.com

Chinese Scienti sts Regenerate,

Duplicate Gastrointestinal Organs

by Cul tur ing Stem Cell s in Vitro

Chinese biologist Prof. Rongxiang Xu and his team

announced that they have successfully regenerated

and duplicated gastrointestinal organs by culturing

stem cells in vitro. Earlier, the researchers reported that

they had repaired and regenerated human skin by cul-

turing adult stem cells in vivo and in situ.

In the new experiments, tissues of gastric and

intestinal walls from mice were sampled for culture in

vitro. A specially formulated and combined life sub-

stance, known as a Gastro-Intestinal Capsule (GIC),

was added in the culture medium to promote stem cell

proliferation.

During the culture process of gastric tissues,the GIC initiated sub-mucosal cell clusters. These

cells divided progressively while cloning to form tis-

sues and continuing to cultivate until new tissues were

formed, according to the scientists. In the culturing of

intestinal tissues, cell clusters near intestinal mucosa

membranes were initiated through GIC and formed as

stem cells with a potential for indefinite cultivation.

These stem cells then differentiated into

brush border mucosal tissues, which had a function to

(Continued from page 5) absorb, as well as into secretory cells which are located

in the intestinal tract, and were persistently cultivated

to constitute new intestinal tissues.

According to the scientists, these two experi-

ments verify two main claims of Prof. Xu and his team:

1. Stomach and intestine cells and tissues,

which are two different types of organs, were success-fully duplicated.

2. The key to the necessary life substance for

cells, the smallest units of life, were discovered.

Unlocking the door to new dimensions and

possibilities in stem cell research, GIC is a unique and

exceptional cell culture medium promoter rich in nu-

trition as well as a beneficial cell-protecting agent, the

scientists said in a statement. It is regarded as the sole

life substance of its kind in the world that can success-fully initiate the repairing and regenerating of cells and

tissues.

Signif icant Value

According to the researchers, the results of their studies

coupled with the effects that GIC has on gastric and

intestinal cells have profoundly significant application

value to clinical medicine.

In the treatment of gastric diseases, GIC not

only protects the gastric wall, but also physiologically

repairs gastritis and ulcers completely, the scientistssaid. As for intestinal functions; GIC can repair in-

jured intestinal mucous membranes, and insure mu-

cosal epithelial cells to evenly absorb nutrients and en-

hance intestinal absorption functions.

The researchers said the experiments prove

that GIC completes three steps of tissue replication by

stem cells: cultivation of stem cells, linkage of various

stem cells, and tissue constitution.

It further validates the life science value of

the human mapping process of the in vivo and in situ

organ regeneration and replication by Professor

Rongxiang Xu, according to the scientists.

Experiments have explicitly shown that gastric tissues

and intestinal tissues from the embryo of mice, when

cultured in GIC, release free single cells. After continu-

ous cultivation, unicellular clonal connections formed,

finally leading to tissue constitution. This process con-

tinues for several months of culturing. As such phe-

nomenon and results can only be completed by stem




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7

cell development, it is actually the first time ever that

organs had completely developed in vitro in the history

of life science.

The test results also suggest that injuries to

organs initiate the potential of stem cells in vivo and in

situ, making it possible for stem cells of organs in vivo

and in situ to replicate new gastric and intestinal wallsand mucous membrane.

This discovery has advanced the international

embryonic stem cell research into its current direction

and final goal of stem cell research which is the re-

pairing, regenerating and replicating of tissue organs,

they said.

According to the scientists, the science and

technology information search agency, a subsidiary of

Chinas Science and Technology Ministry, completed

data searching and due diligence in the area of the re-

search. It found that in the last twenty years no similarreports have been published. This suggests that Profes-

sor Xus findings are original. The State Stimulant and

Sports Nutrition Testing Research Center also in-

spected the capsules contained in GIC and found no

stimulants prohibited by the International Olympic

Committee of 2000.

Contact: Prof. Rongxiang Xu via e-mail at

[email protected]

News Br iefs

NIH, Health and Human Services Release More

Guidance for Stem Cell Researchers

The federal Office for Human Research Protections

(U.S. Department of Health and Human Services) has

published some guidelines for Institutional Review

Boards (IRBs), investigators and sponsors considering

research activities involving human embryonic stem

cells, materials derived from them, human embryonic

germ cells from fetal tissue, or materials derived from

them.

To view the guidelines, visit http://ohrp.osophs.dhhs.gov/references/HESCGuidance.pdf.

The agency also has a list of frequently asked questions

on federal funding for embryonic stem cell research.

The questions and answers focus on applying for fund-

ing under the extended deadline, what to do if you miss

the extended deadline, prohibited areas of research, the

requirement to identify the stem cell line to be used,

(Continued from page 6) IRB review, and regulations on importing cells from

other countries.

To view the FAQs, visit http://grants.nih.gov/

grants/stem_cell_faqs.htm.

Several embryonic stem cell lines approved for federal

research funding were developed outside the United

States. Researchers who want to work with them maybe required to get permission to import them. NIH ex-

plains its policies for importing biological specimens at

http://grants.nih.gov/grants/guide/notice-files/NOT-

OD-02-103.html. Details and contact information are

given for USDA, CDC, and FDA.

Researchers Find Magic Ingredient for Neural

Stem Cells

Researchers at the Max-Planck Institute of Neurobiol-

ogy in Germany have uncovered a key molecule that,when added to astrocytes that do not normally act as

stem cells, start producing new neurons.

Recent experiments have provided strong evi-

dence that in the developing fetal brain, a subsection of

a group of cells called radial glial cells act as neural

stem cells, giving rise to neurons. Related cells in the

adult brain called astrocytes can also act as neural stem

cells.

But what gives certain radial glial cells and a

very small number of astrocytes in two discrete adult

brain areas their stem cell capabilities has been a mys-

tery.Astrocytes that naturally act as stem cells are

a very rare cell type - but if we understand more about

the differences between 'normal' astrocytes and neuro-

genic astrocytes, we could potentially use the ones

found throughout the brain for neural replacements,

says researcher Magdalena Gtz, head of the neuronal

specification group at the neurobiology institute.

Gtz and her colleagues first worked on mouse

radial glial cells, which until very recently were thought

to be simply helper cells, guiding the growth of neu-

rons in the fetal brain.

The team studied transcription factors -

molecules that regulate which genes are transcribed

and then translated into proteins. They found that ra-

dial glial cells that lacked a functional form of a tran-

scription factor called Pax6 could not generate neu-

rons. But when Pax6 was introduced into glial precur-

sor cells, these cells started to produce neurons.

The team found that the introduction of Pax6




8/8

8

into mouse astrocytes had the same effect. This raises

the prospect of using normal astrocytes taken from a

patient with brain damage to make new neurons, for

use in treatment.

Finding molecular markers that indicate

whether a radial glial cell can act as a stem cell or not

will also help researchers purify samples, says Gtz.Contact: Dr. Magdalena Gtz, 49-89-85-78-

36-29, http://www.neuro.mpg.de/Neu-

ronal_Specification/

Donor Brain Stem Cells Do More Than Just Grow

Neural stem cells (NSCs) can alleviate neural degener-

ation by instructing host cells to regenerate, rather than

by maturing into neurons themselves, Harvard neurolo-

gist Evan Snyder said on November 11. In mice with

Purkinje cell (PC) degeneration, Snyder reports, NSCsmay be reconstituting the PC layer either by protecting

host cells or by stimulating a more vigorous regenera-

tive response.

We think this may be the donor cells secreting

things that change the host, Snyder said. And this

(Continued from page 7) may apply not just to NSCs but to many other types

[of stem cells]. In fact, he suggests, the new model

may explain some functional results now observed in

other stem cell experiments.

Snyder and his colleagues transplanted donor

NSCs into the cerebella of nervous (nr), purkinje-cell-

deficient (pcd) and lurcher (lc) mice with rapid degen-

eration of PCs. Transplanted NSCs dispersed broadly,but only a minority of them matured into neurons and

glial cells, the researchers say.

But when transplanted at early stages of PC

degeneration, NSCs nevertheless protected the cells

from spontaneous degeneration. When grafted into

newborn mice, the NSCs also preserved cerebellar ar-

chitecture in both PC and granule cell populations. In

such mice, motor deficiencies were reduced or absent,

the scientists report.

Contact: Dr. Evan Y. Snyder, 617-355-6070,

http://www.childrenshospital.org


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