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Commercial Applications of Stem Cells NIH Workshop Lecture Bethesda, Md Oct 6 th , 2010 By: Jim Hardy President & CSO HemaCell Perfusion, Inc.
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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 .
