stem cells and regenerative medicine: commercial implications for the pharmaceutical and biotech...

7/27/2019 Stem Cells and Regenerative Medicine: Commercial Implications for the Pharmaceutical and Biotech Industry

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Neural Stem Cells:

Developmental Insights with Potential Therapeutic Lessons

Evan Snyder

Harvard Medical School

Incoming Director and Professor, Program for Developmental

& Regenerative Cell Biology

Burnham Institute

Incoming Director Basic Science Research, Division ofNewborn Medicine, Department of Pediatrics

University of California, San Diego


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A series of reciprocal molecular communications between exogenous neural

stem cells (NSCs) and their host environments -- in addition to cross-talk

between NSCs -- have provided a basis for some appealing possibilities for CNS

therapy in certain situations as well as providing a better understanding of the

fundamental role of NSCs in development. First, abnormal hosts seem to alter

the fate and behavior of immature, uncommitted NSCs. For example, duringphases of active neurodegeneration, factors seem to be transiently elaborated to

which NSCs may respond by migrating (even long distances) to degenerating

regions & differentiating specifically towards replacement of dying neural cells.

NSCs may "attempt" to emulate in the brain what hematopoietic stem cells do inthe periphery: repopulation & reconstitution of ablated regions. These "repair

mechanism" may reflect the re-expression of basic developmental principles

(particularly during particular temporal "windows" following injury) that may be

harnessed for therapeutic ends. In addition, NSCs in their native state (even

without specific genetic engineering) appear to alter host tissue such that a more

favorable milieu is established for the protection of imperiled host cells and/or

the activation of intrinsic regenerative processes.

Gene Therapy (2002) 9, 613-624


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Some of these process may derive from cues that NSCs provide to each other as

one cell in a clone interacts with, "instructs" the fate of, or "chaperones" its sister

cells through molecular cues; host cells may be bystanders who benefit from this

interaction. Many of these factors are expressed in a regulated fashion, quite

different from the mode by which they might be expressed via a viral vector, non-biological system, or even an alternative non-neural cell type. Interestingly,

attempting to augment one "intrinsic" factor within the neural stem cell may

actually alter an apparent delicate intra-cellular "balance" in unanticipated and

sometimes undesirable ways. Therefore, a better understanding of how neural

stem cells regulate their expression of various "therapeutic" molecules is alsopivotal to understanding both development and repair. Taken together, and based

on observations in various animal models of CNS injury & degeneration, NSCs

may theoretically serve both as mediators of cell replacement and as vehicles for

protein delivery (e.g., including the expression of factors that might enhance

differentiation, neurite outgrowth, connectivity, & neuroprotection). Whencombined with certain synthetic biomaterials, NSCs may be even more effective in

"engineering" the damaged CNS towards reconstitution by, once again, "tapping"

into fundamental developmental processes.

Gene Therapy (2002) 9, 613-624

Continued:


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Progenitor Cells in the Adult Substantia Nigra

The Salk Institute

Dieter Chichung Lie

Fred. H. Gage


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In Parkinson's disease, progressive loss of dopaminergic neurons in the substantia

nigra pars compacta (SN) leads to debilitating motor dysfunction. One currenttherapy aims at exogenous cellular replacement of dopaminergic function by

transplanting dopamine producing cells into the striatum, the main projection area

of the SN. However, results utilizing this approach have shown variable success.

It has been proposed that cellular replacement by endogenous stem/progenitorcells may be useful for therapeutic interventions in neurodegenerative diseases,

including Parkinson's Disease. Although it is widely accepted that progenitor cells

are present in different areas of the adult central nervous system, it is unclear

whether such cells reside in the adult SN and whether they have the potential to

replace degenerating neurons. We have identified a population of actively

dividing progenitor cells in the adult SN, which in situ give rise to new mature

glial cells but not to neurons. However, when removed from the SN, progenitor

cells display a broader neural potential and differentiate into all three major CNS

lineages, including neurons.Transplantation of freshly isolated SN progenitorcells into the adult hippocampus showed that these cells also have a neuronal

potential under in vivo conditions.

Science 287:1433-1438


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In summary, these results indicate that:

Neural progenitor cells reside in the adult SN;Neural progenitor cells have an intrinsic potential to

give rise to new neurons;

The environment of the adult SN is not permissive for

neuronal differentiation of intrinsic neural progenitor

cells;

This developmental potential of SN progenitor cells

might be useful for future endogenous cell replacementstrategies in Parkinson's disease.

Science 287:1433-1438


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Selective Amplification of Stem Cells for

Clinical Application

Jan W. M. VisserVice President Stem Cell Research

Viacell, Inc.


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The widespread clinical use of stem cells will depend on theability to access and manufacture stem cells in large numbers

with high quality. A selective amplification protocol was

developed, which efficiently expands the hematopoietic stem

cellcompartment for transplantation while minimizing thecontent of differentiating and maturing cells.Using cord

blood as a source of stem cells the average expansion of

CD34+/CD38- is 40-fold in a 2 week period of selection and

culture. This product is being tested in a clinical trial.


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We are also exploring the plasticity of stem cells from cord blood in a rat strokemodel. In this case the selectively amplified cord blood derived producthad an

effect when i.v. injected into a rat model for brain stroke, where it significantly

enhanced functional recovery of rats which had received an infarct relative to

control animals having received the same debilitating procedure. Manufacturedstem cells from cord blood using selective amplification may provide a source

of immunologically stem cells for use in this and other neural diseases.

Additionally, in our hands stem and progenitor cells for pancreatic isletsand

beta-cellscan also be cultured and expanded ex vivo for several months in anundifferentiated state. They produce islet-like structures when induced to

differentiate. These cells are tested in animal models of type 1 diabetes.

Although the frequency of expanded pancreatic stem cells is low (


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Plasticity of Circulating Adult

Bone Marrow Stem Cells

Tim Brazelton, Ph.D.,

Research Scientist

Stanford University School of Medicine


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Generally, it has been thought that only embryonic stem

cells (ES) are pluripotent (capable of generating all or most

cell types) while stem cells in the adult were considered to

be restricted in their regenerative potential to the tissues in

which they reside. However, observations from our

laboratory and others have found that when adult bonemarrow cellsare administered intravascularly into adult

recipients, that these cells home to various organs where

they give rise to cells typical of that tissue, such as neurons,

skeletal myofibers, liver hepatocytes, and intestinal andrespiratory epithelium.


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Since our experimental methods take great care to reproduce physiological

conditions (i.e., no intervening tissue culture, no tissue injury or disease in

recipient, intravascular delivery) our results suggest that these

"transdifferentiation" events are likely to occur in healthy adults from cells

that normally circulate. While most reports have found that under

physiological conditions (i.e., no overt injury) that "transdifferentiation" is a

rare event, we've found that in some cases that bone marrow appears to be a

robust source of tissue stem cells. For example, one year after bone marrowtransplant and in the absence of injury, up to 10% of the myofibers in one

skeletal muscle contain bone marrow derived nuclei. Our current efforts

involve the establishment of novel in vivo and in vitro screens to identify the

circulating progenitor cells and factors involved in these

"transdifferentiation" events. Such knowledge will likely have enormous

potential for the development of novel therapeutics which take advantage of

the dramatic and inherent plasticity of circulating adult stem cells.

Continued:


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What is a stem cell? Classic definition is based on function and is still agreed

upon by essentially all investigators:

- Stem cells are cells capable of:

proliferationself renewal

production of a large number of differentiated progency

regeneration of tissue after injury

flexibility in the use of these options

Additional characteristics classically associated with stem

cells that may need to be re-evaluated given recent data:

Tissue specificUndifferentiated (unspecialized)

Linear, irreversible differentiation pathways

A stem cell is a cell ( i.e., a discrete, identifiable entity)


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What is a stem cell? (Revisited)

Tissue specific?

-- No: Not limited to specific tissue

Undifferentiated / unspecialized / primitive? -- Yes: Hard to identify; not many markers

-- No:

Some stem cells are differentiated:

-Bulge stem cells (skin) express keratin 5 and 11 - Multipotent neuronal stem cells ciliated cells, GFAP and nestins

They seem pretty specialized:

- Monitor environment & dynamic response to diverse signals

* Plasticity requires active maintenance * NSC exist throughout brain generate progeny in only specific locations

- Migrate throughout body

- Generate diverse cell types


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Linear, irreversible differentiation pathway?

--No: * Cloning; Forced cell fusion

* Dedifferentiation

Stem cells are heterogeneous

-- Stem cells are different to isolate * Purification protocols typically enrich;

* Degree of enrichment balanced with the capture of stem cell capacity

A stem cell is a cell ( i.e., a discrete, identifiable entity)?

-- Since many types of cells from distinct tissues can be recruited to hehave asstem cells:

-- We suggest that the concept of a stem cell most accurately refers to acellular function that is recruitable in many cell types ( i.e., a cellular program like

apoptosis)

-- Cells classically identified as stem cells likely have the greatest propensity to

act as stem cells but other cells may be recruited to function as stem cells if theneed arises.


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Conclusions:

Dramatic plasticity exists within adult bone marrow-derived

cells

Cell fate transitions are physiological events

Cell fate transitions are often rate but can be increased

-- inhibition of local regeneration populations

-- increased need for tissue regeneration

Stem cell function may not be limited to stem cells


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Cell Expansion in the AastromReplicell(tm) Cell

Production System: Automated Single PassPerfusion for Cell Expansion

Steven N. Wolff, M.D.

Vice President Medical Research

Aastrom Biosciences, Inc.


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Cell therapy is currently used for hematologic restoration,immunologic vaccination and tissue regeneration with further

promise due to broad transdifferentiation of adult marrow derived

stem cells. Aastrom has developed a fully automated, GMP

compliant, computer directed, closed system for the growth of thesehuman cells.The presentation will highlight the production, cell

characterization, pre-clinical and clinical studies of various cells

grown in the ARS/CPS platformby addressing these specific goals:

1. To demonstrate the ARS/CPS platform and single pass perfusion

2. To show laboratory and clinical studies of hematopoietic cell expansion

3. To show substantial expansion of mesenchymal stem cells

4. To demonstrate the automated production of antigen loaded dendritic cells5. To demonstrate the automated production of antigen specific T-cells

6. To discuss the capability of the ARS/CPS to grow and expand other cell types


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An "Identity Crisis" For Stem Cells

Naohiro Terada, M.D., Ph.DAssociate Professor

University of Florida


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Over the past few years, a traditional cell lineage dogma has been challengedby a group of studies showing plasticity in various types of adult-derived stem

cells. Traditionally, stem cells in the adult body were thought to be limited in

potential,such that a hematopoietic stem cell in the bone marrow, for instance,

could only become a blood cell. However, recent reports have demonstrated

that transplantation of hematopoietic stem cells, for example, can lead to

production of muscle cells, liver cell types, cells of the brain, and other cell

types. This research has caused much excitement over what is called

'transdifferentiation,' or the ability to acquire broadened differentiation potential.

Work focusing on the ability of adult stem cells to become a variety of othercell types has been a hot topic, making implications for plasticity in tissue-

specific adult stem cells. Decidedly, this work has inferred that these various

adult cells could have the same multi-potency as embryonic stem (ES) cells.

The ability to avoid using ES cells for clinical use is attractive, as it would avertmuch of the current political and ethical controversy over use of fertilized

human eggs in research.


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In article recently published, however, we demonstrated that

cell fusion could be an alternative explanation for apparently

"transdifferentiated" cells. A major question remains to be

answered: does transdifferentiation truly occur in committed

adult cells in our body? Continued work is necessary for acomplete understanding of the exciting but unclear process of

transdifferentiation.


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First Products of Stem Cells from Stem

Cell Technology: A Progress Report

Allan Robins, Ph.D.

Chief Scientific Officer

Bresagen


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Prospective cell types for treatment ofneurlogical disease in including Parkinson's

have reached the rodent testing stage.

We take a forward look at the challenges

concerned with moving products into clinic.


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PANEL: STEM CELLS: PATENTS, LICENSING

AND INTELLECTUAL PROPERTY

Elizabeth R. Donley

Legal Counsel

WARF/WiCellDavid Earp, J.D., Ph.D.

Vice President, Intellectual Property

Geron CorporationKurt G. Briscoe, J.D.Partner

Norris McLaughlin & Marcus, P.AKevin Noonan, Ph.D.,Partner

McDonnell Boehnen Hulbert & BerghoffBill WarrenPartner

Sutherland Asbill & Brennan LLP

MODERATOR:

PANELISTS:


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As interest in adult and embryonic stem cellshas grown, issues of intellectual property in,

and licensing of rights to, the cells have been

at the forefront of many discussions. Thepanelists addressed these issues and the

audiences have opportunities to put questions

to the panel for discussion.


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Regenerative Medicine for Brain and

Spinal Cord Repair

Annemarie Moseley, Ph.D., M.D.Acting CEO

Layton BioScience, Inc.


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Mission Statement

To develop and commercialize cell

therapy products for repair of

disorders of the central nervoussystem, such as stroke, Parkinsons

disease, Huntingtons disease and

spinal cord injury


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Large Unmet Need

As the population ages, diseases of the central nervous

system have an increasing impact on society Incidence of stroke increasing and one third of all strokes

are left with debilitating effects which require assisted

living

There are no medical products available which can repair

the nervous system and it cant repair itslef

Challenge: decrease functional loss and introduce repair of

the brain and spinal cord


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LBS-NeuronsTM: Proprietary Cell Product

Differentiated, human neural progenitors Highly characterized:

* Form functional synapses

* Secrete neurotransmitters

Non-tumorigenic

Reproducible manufacturing process, produced

under GMP on-site at Layton


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Long-term engraftment of LBS-Neurons in ratsand primates

No abnormal growth or differentiation

No migration from site of implantation Functional improvement in animals receiving

LBS-Neuron implants compared to controls

No tumorigenicity

LBS-NeuronsTM: Preclinical Studies in Stroke


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Safty and feasibility confirmed in 12 patients with

chronic stroke

Seven of twelve patients had clinically significantimprovement in motor function

Positive PET scans correlated with improved

motor function

LBS-NeuronsTM: Phase 1 Trail in Stroke


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Dose escalation safety study

* 18 patients

* 5 and 10 million cell dose and control groups

Two clinical centers:

* University of Pittsburgh

* Stanford University

Enrollment completed

Early data suggests that potential cognitive and sensorychanges as well as motor changes

LBS-NeuronsTM: Phase 2 Trail in Stroke


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Summary

The promise of neural cell therapy lies in the reestablishment of

neural connections or of the replacement of the milieu needed

by regenerating neurons. Layton has led the field of neuronal

cell implantation by providing a reproducible GMP neuronal

cell product as an alternative to fetal cell transplants. Layton

has patented the process for producing large quantities of purecultures of LBS-Neurons from NT2/D1 cells. Early data

demonstrated that LBS-Neurons could polarize, form functional

synapses and undergo site-specific differentiation. Layton has

now completed more than 2 year followup in the Phase 1 trialof implantation of LBS-Neurons into the basal ganglia region

of the brain of chronic stroke patients.


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The company has recently completed treatment of all

patients in a Phase 2 clinical trial in chronic stroke patients

with higher doses of the cells. In addition to PET scans,

and motor function testing, cognitive studies have been

performed in these chronic stroke patients. Recent datahave additionally suggested an impact of the neurons in

acute cortical stroke. The company anticipates entering

clinical studies to further evaluate the implantation of

LBS-Neurons in Huntington's disease patients and chronicspinal cord injury patients.

Summary (Cont.)


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Overcoming the Supply Issue:

Cell and Organ-Based Therapeutics

David Ayares, Ph.D.

VP, Technology

PPL Therapeutics


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The primary bottleneck in the development of lifesaving

therapies for such diseases as diabetes, parkinson's, alzheimers,and whole organ failure (heart, kidney, lung, pancreas), is the

limited supply of appropriate donor cells and organs for

transplantation. Xenografts from alpha 1,3 gal knockout pigs, in

combination with tolerance regimes, provide the promise of anunlimited supply of cells and organs, which can be applied to

humans without risk of rejection.Cloned pigs with knockout of

alpha 1,3 galactosyl transferase gene are now available to begin

the pivotal pig-to-primate preclinical experiments. In addition,significant progress has been made in the differentiation of

embryonic stem cells into a varietyof therapeutic cell types,

which brings the promise of cures (not just therapies) for a

number of debilitating diseases. This presentation addressedrecent progress in xenotransplantation, as well as, new methods

of generating and differentiating pluripotent stem cells.


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Tissue Engineering Using Stem Cells:

Current Applications and Future Potential

Andreas Kern, Ph.D.Principal Scientist

Advanced Tissue Sciences, Inc.


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Tissue Engineering has the potential to become a major

source for Regenerative Medicine. The combination of

stem cells and scaffold technology may allow for the

generation of transplantable materials for, among others,

cardiovascular and musculoskeletal applications.However, several obstacles remain for the acceptance of

such transplants. These challenges include the use of

embryonic versus adult stem cells, an understanding of

pathways to direct differentiation into specialized tissues,and the issue of alloreactivity.

Introduction


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Pluripotent Cells for Tissue Engineering

Adult origin

-Bone marrow derived (Pittenger et al., 1999) * chondrocytic differentiation

* osteocytic differentiation

* adipocytic differentiation

- Adipose tissue derived (Zuk et al., 2001)

- Brain derived (Uchida et al., 2000)

- Skin derived (Toma et al., 2001)

Embryonic stem (ES) cells

- Derivatives of three germinal layers (Thompson et al., 1998)

- Cardiomyocytes (L. Field, A. Wobus, Kehat et al., 2001)


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Cardiomyocyte Summary

ES cells as potential source for large quantities ofcardiomyocytes

Challenges: 1) Yield of cardiomyocytes

2) Source of precursor cells

3) Novel perfusion bioreactor technology for tissue survival

4) Synchronized beating


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Summary Allogeneic Rejection

Expression of rejection-related molecules may bemodulated by ECM and differentiation

Human fibroblasts with similar expression patterndo not exhibit acute rejection

ES-derived tissues may have a similar potential


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Tissue Engineering and Pluripotent Cells

Examples

-Embryonic cardiomyocytes within polymeric sheets (Shimizu et al.,2002) - Osteocytic development in rat (Gao et al., 2001)

Opportunities of cell-scaffold technology

- In vitro growth, matrix deposition and tissue formation - Cryopreservation

- Off-the-shelf availability

Challenges:

- Adult vs embryonic cells

- Immunology

- Perfusion


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The Road to Longevity: The Synergy of

Centenarians and Stem Cells in

Regenerative Medicine

Doros Platika, M.D., Ph.D.

President and CEO

Centagenetix


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Longevity is a heritable human trait, much like height, weight,and susceptibility to diseases such as breast cancer. This was

the conclusion of the New England Centenarian Study which,

when looking at the characteristics of individuals surviving to

very old age, noted that centenarians:

tend to cluster in families (both horizontally within a

generation as siblings and vertically through generations); delay the onset of the effects of ageing (i.e. are markedly

more youthful than their same-age cohorts throughout

their lives);

escape catastrophic disease throughout their life; and, delay the onset of or escape the diseases associated with

ageing (e.g. Alzheimers Disease)


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Our primary research and development goal for the next five yearsis to

gain an understanding of the genetic basis for longevity, whether in the

negative as the absence of genes conferring susceptibility to particular

diseases, or in the positive as beneficial or protective genes directly related

to longevity. There is accumulating evidence that not all gene variants

(alleles) are created equally the specific gene variant an individualinherits affects susceptibility to a wide range of ailments including

diabetes, vascular disease, and dementia. Because the ability to survive to

an extremely old age requires evading such calamities, it is expected that

centenarians have a relative paucity of these disease alleles. Wehypothesizes that a second class of genetic variants affects health and

longevity more broadly, and conceptually these may be thought of as

disease resistance or longevity promoting genes. For example, genetic

differences among enzymes responsible for DNA and cellular repair may

account for some of the heritable component of longevity. An individualfortunate enough to possess an extremely effective repair facility may be

able to partially negate the detrimental effects of both nature (the

environment) and nurture (detrimental genes they may inherit).


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Centagenetix plans to gain understanding of the genetic basis for

longevity using association studies comparing centenarians to

various control and disease populations. Such population genetics

studies are an extremely powerful approach to drug target discovery.

The reason is simple: association studies seek the genetic basis ofdisease susceptibility and therefore tend to identify causes over

effects. In contrast, other target screens, such as gene expression

analysis, confound cause and effect its difficult or impossible to

determine whether a change in mRNA expression is an effect, a

cause, or coincident with a process being studied. The Holy Grail for

investigators doing gene expression analysis would be computational

methods which could reconstruct pathways from the massive amount

of data these studies generate. This has proven hopeless, and the

same will be true for the coming wave of proteomics platforms. Withgenetic variation this is not an issue: disease alleles promote disease

not the converse.


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The critical pointis that, contrary to industry

experience to date, gene targets generated throughthese types of association studies will be of very high

quality, dramatically reducing the number of false

positive targets carried through for further study.

This will have profound effect in reducing the time

and cost associated with target validation, a significant

current bottleneck in the drug development process.


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Therapeutic Cloning and Alternative

Strategies for the Production of Autologous

Totipotent Stem Cells

Michael D. West, Ph.D.

President and CEO

Advanced Cell Technologies


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Advanced Cell Technologys (ACT) cell therapy

programs are built upon a new class of cells able to form

virtually every cell type in the body.

This technologyplatform therefore has unusually broad applications in

medicine. These primordial stem cells includeEmbryonic Stem (ES) cells and other cells from the

Inner Cell Mass (ICM) of preimplantation embryos.The biotechnology industry hopes to produce many new

therapies from these cells, for instance, neurons for the

treatment of Parkinsons disease and spinal cord injury,

heart muscle cells for heart failure, cartilage for arthritis,

pancreatic cells for diabetes, as well as many others.


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As promising as ES cell technology may seem, it does

not solve the critical problem of histocompatibility.Human ES cells obtained from embryos derived during

in vitrofertilization procedures, or from fetal sources,

are essentially cells from another individual

(allogeneic). This means that they, or any cells madefrom them, would be at risk of being rejected iftransplanted into a human being. To solve this problem,ACT is performing research on three means to

manufacture embryonic cells identical to a human adult,

this is to say, autologousembryonic cells.


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Somatic Cell Nuclear Transfer: In this technique, commonlydesignated Human Therapeutic Cloning a patients body cell iscombined with an egg cell that has its DNA removed. As a resultthe body cells DNA is reprogrammed back to an embryonic state,

and totipotent stem cells are produced identical to the patient.

Parthenogenesis: In this technique a womans oocyte isdirectly activated without the removal of its DNA to begin

development on its own, forming a preimplantation embryo fromwhich totipotent stem cells are isolated.

Ooplasmic Transfer: In the reverse of nuclear transfer,ooplasmic transfer involves the removal of the cytoplasm of anoocyte and transferring it into the body cell of a patient thereby

transforming the patients cell into a primitive stem cell.


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StudiesonOrgan(1)Regeneration in situor in vitro

Xu, Rong-xiang, M.D.

President of MEBO International


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Introduction

This is a tremendous research project in series

which started 14 years ago. Our purpose is toinitiate and maintain the potential regenerative

cells in tissues to proliferate and regenerate new

cells to take places the flawed, worn-out,destroyed, or apoptosis cells in vivoand in situ,

which assures the well-working structure and

function of the tissues or organs. Based on this

theory and the successful progresses we made in it,

we established Regenerative Medicine.


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Purpose and Method

Based on the classifications in Anatomy of Human

Function, we divide the whole living human body into

206 functional tissue units. We set up different

experiment models by culturing each of these units in

vitro. Using these well-established modelswe are

doing the research of seeking life regenerativesubstances(3)which are able to initiate, maintain cells to

be alive, to proliferate and to regenerate. And then, we

put these life substances back into organism to fulfill the

organ regeneration or physiologically repair in vivoandin situ, which reaches our goals to cure the diseases and

ensure organ healthiness.


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Project Procedures1Studies on seeking the tissue cells in situof organ which have

the potential to regenerate.

2

Taking out these potential regenerative cells to culture invitro, initiate the proliferation and differentiation of these cells in

order to form tissues or organs as same as the ones in situ.

3Studies on seeking the Life Regenerative Substances which

are able to initiate, maintain cells to be alive, to proliferate, to

different, and to regenerate using the successful procedures and

models in vitro.

4

Putting these life substances back into organism to fulfill theorgan regeneration or physiologically repair in vivoand in situ.


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Key Words1Tissue Organ: The tissue unit which has the ability

to carry out organism functions.

2Potential Regenerative Cell: The cells which have thepotential ability of regeneration similar as stem cell but

regularly exist in tissue/organ as normal cells.

3Life Regenerative substance: The substances whichare able to initiate and maintain cell proliferation,

differentiation, regeneration and to form tissue or

organs eventually.

4In situThe positions where the cells, tissues or

organs exist in organism.


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Main contents of this report

1The dynamic study on Potential Regenerative Cell;

2The process of mouse gastrointestinal mucosa

regeneration in situor in vitro;

3Cultivation of mouse pancreas in vitro;

4Hair follicle regeneration in vitro;

5Human skin organ regeneration in situ;

6Clinical studies on tumor cells affected by liferegenerative substances.


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1) Establish the technology of normal tissue cell culturein vitro;

2) Fulfilled the human skin organ regeneration in vivo

and in situ;

3) Achievements on clinical application of skin organ

regeneration for 15 years;

3) Set up some functional tissue organ (such as

gastrointestinal mucosa) regeneration models in vitro.

4) Successfully finished 21 life regenerative substances

which can fulfill 21 types of functional organ

regenerations.

Results:

PANEL: COMMERCIAL IMPLICATIONS OF STEM

CELL RESEARCH FOR THE PHARMACEUTICAL


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CELL RESEARCH FOR THE PHARMACEUTICAL

AND BIOTECH INDUSTRIES

Linda Powers

Managing Director

TOUCAN CAPITAL

MODERATOR:

PANELISTS:

Sami Hamade

V.P., Compass GroupGuidant CorporationRodney Altman

Principal

Piper Jaffray Ventures

Joel F. Martin

Partner

Forward Ventures

Robert Caffarata

Director, Emerging VenturesMedtronic VascularMiles Greenberg

Principal

A.M. Pappas and Associates


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As the pharmaceutical industry prepares

for potential involvement in medicalbreakthroughs afforded by stem cell

research and regenerative medicine,

venture capital and investment managerson this panel convened to discuss the

commercial and financial aspects; both

present and future.

stem cells and regenerative medicine: commercial implications for the pharmaceutical and biotech...

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