commercial applications of stem cells: nih lecture 06 oct 2010

Commercial Applications of Stem Cells

NIH Workshop LectureBethesda, Md Oct 6th, 2010

By: Jim Hardy President & CSO HemaCell Perfusion, Inc.

BackgroundWittenberg University University of RochesterBRL/Life Technologies, Inc.BP SolarIn Vitro TechnologiesLavaAmp & Hemacell Perfusion @ FITCI

Stem Cell Market Projections and Time Line

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

$-

$1,000

$2,000

$3,000

$4,000

$5,000

$6,000

$7,000

$8,000

$9,000 1961: Canadians Jim Till & Ernest McCulloch prove the existence of stem cells (Nature 1963)

1978: Hematopoietic SC discovered in UCB

1981: mouse ES cells isolated

1988: HSC isolated from blood

1992: Adult neural SC discovered

1994: first Cancer SC discovered

1996: Dolly the Sheep

1998: first human ES line

RegMed 2.0

US

D (

mil

lion

s)

The Gartner “Hype Cycle”

http://en.wikipedia.org/wiki/File:Gartner_Hype_Cycle.svg

Commercial Applications of Stem Cells

Picks and ShovelsTissue sourcing, collection, isolation and banking

Cell Culture medium, Growth factors, cytokines, ECM proteins

The challenges of ex vivo expansion

QC Testing, characterizationStem cells in Drug Discovery

Tissue sourcing, collection, isolation and banking

Tissue sourcing, collection, isolation and banking

Accredited Tissue Banks Whole Organs-Transplant grade Surgical resection Birthing centers, mid-wivesLive donor, bone-marrow, blood collection

Tissue sourcing, collection, isolation and banking

Tissue sourcing, collection, isolation and banking

Tissue sourcing, collection, isolation and banking

Density Gradient centrifugation

Tissue sourcing, collection, isolation and banking

Immuno magnetic separation

http://www.miltenyibiotec.com/Stemcell/NN_736_MACS_Cell_Separation_the_principle_1.aspx#1

Tissue sourcing, collection, isolation and banking

Cell Sorting by Flow cytometry

Tissue sourcing, collection, isolation and banking

Vita34, Leipzig DE http://www.vita34.de/vita/en/laboratory.php?navanchor=2110006

Cell Culture medium, Growth factors, cytokines, ECM proteins

Component g/L Component g/L

CaCl2•2H2O 0.265 L-Methionine 0.03

Fe(NO3)3•9H2O 0.0001 L-Phenylalanine 0.066

MgSO4 0.09767 L-Serine 0.042

KCl 0.4 L-Threonine 0.095

NaCl 6.4 L-Tryptophan 0.016

NaH2PO4 0.109 L-Tyrosine•2Na•2H2O 0.10379

L-Arginine•HCl 0.084 L-Valine 0.094

L-Cystine•2HCl 0.0626 Choline-Cl 0.004

L-Glutamine 0.584 myo-Inositol 0.0072

Glycine 0.03 Niacinamide 0.004

L-Histidine•HCl•H2O 0.042 D-Pantothenic 0.004

L-Isoleucine 0.105 Pyridoxine•HCl 0.004

L-Leucine 0.105 Riboflavin 0.0004

L-Lysine•HCl 0.146 Thiamine•HCl 0.004

D-Glucose 1.00 Folic Acid 0.004

Pyruvic acid-Na 0.11

26.2 mM Na Bicarbonate21 mM HEPES2.2 mM Fructose2 mg/mL BSA10.7 g/mL L-Alanine (free base)18.0 g/mL L-Asparagine –H2O16.0 g/mL L-Aspartic Acid17.6 g/mL L-Glutamic Acid9.0 g/mL Glycine13.8 g/mL L-Proline12.6 g/mL L-Serine135 fM Insulin 2.4 M hydrocortisone10 % (v/v) serum

Antibiotic Mix: 2.04 % (v/v) Pen-Strep0.05 mg/mL Gentamicin0.05 mg/mL Amikacin0.20 % (v/v) Fungizone

Cell Culture medium, Growth factors, cytokines, ECM proteins

The challenges of ex vivo expansion

The challenges of ex vivo expansion

The challenges of ex vivo expansion

QC Testing & characterization (……briefly)

• Microscopy• Flow cytometry• Differentiation and function• Proteomics• MicroArrays

FORM-FIT-FUNCTION: Manufactured Parts

Stem cells in Drug Discovery As a replacement for Primary Cells

Skin: Wound healing & absorption models Bone, cartilage Hepatocytes Renal cells Circulatory Cardiomyocytes Neurons Pulmonary cells

In vitro models for metabolic homeostasis & Organogenesis Demonstrate a “stimulation” of injury & repair mechanisms Inhibition of necrosis/apoptosis Tissue specific developmental pathways Cancer Stem Cells

Alzheimer's Disease and neurodegeneration:

The modular systems biology approach to investigate the control of apoptosis in Alzheimer's disease neurodegeneration, BMC Neurosci. 2006; 7(Suppl 1): S2.

Some of the Players

The future?

ConclusionsA business can be built around manufacturing

almost any of the tools for Stem Cell research which precedes clinical testing.

Stem Cell research holds the promise of a new era in medicine, a Gold Rush of sorts.

Before any EUREKA moment, researchers are going to need picks and shovels to find the Gold.

In other words, before the FDA approves the use of manipulated cells for therapeutic purposes, investigators will need to completely understand the systems they’re working with .