Prenatal stem cells - at the forefront of science - Business OpportunityAmniotic Fluid and CHORIONIC VILLI Stem Cells
“… amniotic fluid and chorionic villi represent a new source of stem cells that could have applications in tissue engineering and cell therapy, in particular in prenatal congenital pathologies [1] … “ International studies have demonstrated that Amniotic Fluid and Chorionic villi are the richest sources for Mesenchymal Stem Cells ;
Mesenchymal Stem Cells are the progenitors of Muscles, Bones, Cartilages, Neurons, Liver cells, Renal cells and Hemopoietic cells ;
Biocell Center has developed and patented methods for processing and preserving stem cells from the Amniotic Fluid and Chorionic Villi in GMP conditions;
Biocell Center works with mothers and doctors to cryo-preserve (freeze) small aliquotes of Amniotic Fluid or Chorionic Villi, that are collected during amniocentesis and CVS procedures, or at birth, by collecting the placenta and processing it, without increasing the risk to the patient or fetus.
See the 2,456 pharmacies on the National E-Pharmacy Platform
Prenatal Stem Cells: A Promising Medical Frontier
1. PRENATAL STEM CELLS
at the forefront of science
(February 2014)
Roberto Scarafia – Member of the Board
2. • International studies have demonstrated that Amniotic Fluid and Chorionic villi are the
richest sources for Mesenchymal Stem Cells ;
• Mesenchymal Stem Cells are the progenitors of Muscles, Bones, Cartilages, Neurons,
Liver cells, Renal cells and Hemopoietic cells ;
• Biocell Center has developed and patented methods for processing and preserving
stem cells from the Amniotic Fluid and Chorionic Villi in GMP conditions;
• Biocell Center works with mothers and doctors to cryo-preserve (freeze) small aliquotes
of Amniotic Fluid or Chorionic Villi, that are collected during amniocentesis and CVS
procedures, or at birth, by collecting the placenta and processing it, without increasing
the risk to the patient or fetus.
BUSINESS OPPORTUNITY
AMNIOTIC FLUID AND CHORIONIC VILLI STEM CELLS
Biocell Center Group Roberto Scarafia – Member of the Board 2
“… amniotic fluid and chorionic villi represent a new source of stem cells that could
have applications in tissue engineering and cell therapy, in particular in prenatal
congenital pathologies [1] … “ … the business’ inspiration…
[1] De Coppi et al. Nat Biotechnol 25, 2007 – Kaviani A. et al. J Am Coll Surg 196, 2003
3. STEM CELLS
SOURCES: A COMPARISION
Biocell Center Group Roberto Scarafia – Member of the Board 3
Source: company information
Genetic
Stability
Embryonic Amniotic and Chorionic
(Prenatal)
Cord Blood Adult
High LowMedium Absent
Ethical
Issues
Differentiation
Potential
Totipotent
Very High
Pluripotent Multipotent Multipotent/Unipotent
Proliferation
Potential
Easiness of
Collection
Collected during amniocentesis,
VCS and at birth.
4. STEM CELLS
SOURCES & USES
Biocell Center Group Roberto Scarafia – Member of the Board 4
Stem Cells Types
Embryonic cells Prenatal cells Adult cells
• Derived from the cells of the inner cell mass
of the blastocyst during embryonic
development:
• Advantages: they are able both to
differentiate into any cell type and to self
replicate for numerous generations;
• Disadvantages: they can form tumors and
proliferate endlessly unless control. The
embryo must be destroyed.
• Present in miscarried or aborted fetuses,
amnion membrane, chorionic villi and
amniotic fluid :
• Advantages: genetically stable stem cells
even many cycle of proliferation, very
little quantity necessary, can be expanded
and re-frozen;
• Disadvantages: not yet well-established
human use.
• Present in, cord blood, developed tissues of
infants, children and adults:
• Advantages: they can be autologous and
isolated from the patient being treated;
• Disadvantages: they cannot form as many
types of cells lineages, progenitor cells
and low cell numbers.
Possible uses
• Delivering genetic information for
therapeutic delivery of genes:
• Methods used: virus-mediated-
gene delivery system;
• Potential target diseases: cystic
fibrosis, sickle cell and Gaucher
disease.
• Replacing damaged tissue, bone,
cartilage or organs:
• Methods used: insulin injections,
skin grafts, transplants;
• Potential target diseases:
wounds, burns, skin ulcers,
diabetes and liver transplants.
• Reversing degenerative brain
disorders and spinal cord injuries:
• Methods used: medicines and
surgeries;
• Potential target diseases:
Parkinson, Huntington,
Alzheimer and spinal cord
injury.
• Cancer, cardiovascular and
autoimmune:
• Methods used: surgery,
chemotherapy and
radiotherapy;
• Potential target diseases:
heart disease and breast
cancer.
Gene therapy Replacement therapy Neurological therapy Other therapies
5. AMNIOTIC FLUID AND CHORIONIC VILLI STEM CELLS
FUTURE POTENTIAL USES IN TISSUE ENGINEERING
Biocell Center Group Roberto Scarafia – Member of the Board 5
Diaphragmatic patch
engineered from AFSC
and CVSC before surgical
implantation.
DIAPHRAGMATIC
HERNIA
TRACHEAL
ANOMALIES
Cartilaginous tube
engineered from AFSC and
CVSC seeded onto a
polyglycolicacid matrix.
Engineered bone made
with AFSC and CVSC and
electrospun nanofibers.
BONE DEFECTS
Tissue engineered heart valve
leaflets covered with AFSC
and CVSF.
HEART VALVES
Source: company information
6. BIOCELL CENTER
THE COMPANY AND THE MARKET
• Biocell Center (HQ in Italy, branches in USA and CH) owns patented technologies, know-
how and expertise to process and cryo-preserve perinatal stem cells, specifically amniotic
fluid and chorionic villi derived stem cells;
• Biocell Center is the only company in the world able to cover the whole pregnancy period
with its banking services. The company has in fact recently developed a revolutionary
low-cost technique to collect and preserve stem cells contained in the placenta, that
would otherwise always be discarded at the time of delivery;
• In 2010 the bank UBI Group made a cash investment in the company and now owns 8.3%
of it;
• Biocell Center’s advantages and the market’s strengths are High growth market,
Innovation, Strong management and Labs and Cryo-banks in US and UE countries.
Biocell Center Group Roberto Scarafia – Member of the Board 6
7. Marco Reguzzoni, Founder and Chairman Biocell Center
• Co-Founder and Chairman of Volandia – fligh Museum, MGR Real Estate;
• 2000-2012: Executive Member of the Board: University LIUC, University
of Varese, Malpensa Fair, Milano Fair, IIRV biotech, BPIbank foundation;
• Degree in Engineering at the Politecnico of Milan;
• “International Leadership Program” - U.S. Department of State.
BIOCELL CENTER
KEY PEOPLE
Biocell Center Group Roberto Scarafia – Member of the Board 7
Kate Torchilin, Phd
• 2009-Today: vice-chairman (actual) and CEO (2009-2011) of
Biocell Center Corporation;
• 2008-Today: CEO and founder of ENSPIRE-MEDICA;
• 2003: MBA at the Harvard Business School of Boston;
• 1999: PhD in Chemistry at the Tufts University of Boston.
• Biocell’s Scientific Director – Prof. Giuseppe Simoni:
• 2002: Scientific Director of Toma SpA Advanced Biomedical Assays;
• 1990: Head of the Medical Genetics Laboratory at the “Istituto di Scienze Biomediche” - University of Milan , Italy;
• The firs Chorionic Villi prenatal diagnosis (The Lancet, 1983);
• 1978: Head of activities of pre-born chromosomal analysis and medical cytogenetics at University of Milan.
• Prof. Laird Jackson, MD, Drexel University, Philadelphia (USA):
Founding Director of International Society for Prenatal Diagnosis
• Dr. Edoardo Marcora, PhD, Amgen, San Francisco (USA):
Senior Research California Institute of Technology _ Pasadena, CA (USA)
• Prof. Eugene Pergament, MD, Northwest University Medical School, Chicago (USA):
Clinical professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine;
• Prof. Joe Leigh Simpson, MD, Florida International University, Miami (USA):
Chair & Professor, Department of Human & Molecular Genetics; Professor, Department of Obstetrics and Gynecology;
• Prof. Ronald Wapner, MD, Columbia University Medical Center, New York City (USA):
Professor Maternal-Fetal Medicine, Research in Obstetrics & Gynecology Reproductive Genetics;
• Prof. Fabio Ghezzi, MD PhD, Università dell’Insubria, Varese (Italy):
Professor of Gynecology and Obstetrics at University of Insubria;
• Prof. Angelo Vescovi, MD, PhD, Università of Milan, (Italy):
Professor of Cellular Biology at University of Bicocca, Scientific director of IRCCS San Giovanni Rotondo – Padre Pio (Italy).
SCIENTIFIC ADVISORY BOARD
8. BIOCELL CENTER
INTELLECTUAL PROPERTY
• Biocell Center owns two patents for the collecting method and the cryo-preservation of stem cells extracted
from amniotic fluid and chorionic villi, as well as from placenta at birth. They are registered internationally
(i.e. Europe, US, Canada, India). The first patent was filed in 2007 and the second patent in 2011.
• The added value of these methods are:
o Cells processed in a totally isolated and sterile environment;
o Good Manufacturing Practices compliance;
o Low production and managing costs;
o Strong profit margin (about 85%) on actual prices in the cord blood cryo-preservation market.
Biocell Center Group Roberto Scarafia – Member of the Board 8
9. BIOCELL CENTER
BUSINESS STRATEGY
• After being collected both at private centers and at public hospitals, the samples are
shipped to the Biocell lab for manipulation and cryo-preservation. They are cryo-preserved
and keeped stored in Biocell Center's owned cryo-banks, thus meaning that the company
has direct relationship with its clients and owns its facilities, with no intermediary
contracts with third parties;
• Biocell is willing both to work directly with its own lab and to sign license agreements
with other companies for using its patents and protocols on prenatal stem cells, as a paid
agreement;
• The new Biocell technique to collect stem cells from placenta at birth could be strong
competitive on stem cells cryo-service market, a market that is valuated to be about
US$10 billion in 2013 in the world, estimating that it will grow to US$15 billion by 2015 [2];
• Thanks to its intellectual property, expertise and know-how, Biocell Center’s business
model is easily scalable internationally with limited costs of expansion.
Biocell Center Group Roberto Scarafia – Member of the Board 9
[2] Kyle J Cetrulo ‘Perinatal Stem Cells: An Industry Perspective’ - taken from ‘Perinatal Stem Cells’ by Kyle J Cetrulo, Curtis L Cetrulo, Rouzbeh R Taghizadeh, WiILEY Blackwell 2013
10. BIOCELL CENTER
CONTACTS
Biocell Center Corporation
200 Boston Avenue, Suite 1500 – 02155 Medford, MA, USA
Ph. +1 781 3912040 – Fax +1 781 3950602
Toll Free 866 BIO 2720
Biocell Center SpA
Viale Stelvio 125 – 21052 Busto Arsizio (VA), Italy
Ph. +39 0331 386028 – Fax +39 0331 367321
Toll Free 800 042 433
www.biocellcenter.com – info@biocellcenter.com
Disclaimer
This document expressly or implicitly contains certain forward-looking statements concerning Biocell Center and its business. Such statements involve certain known and
unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Biocell Center to be materially
different from any future results, performance or achievements expressed or implied by such forward-looking statements.
Biocell Center is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new
information, future events or otherwise.
This document does not constitute or form part, or all, of any offer or invitation to sell or issue, neither in the United States of America nor elsewhere, or any solicitation of
any offer to purchase or subscribe for, any securities, nor shall part, or all, of this document or its distribution form the basis of, or be relied on in connection with, any
contract or investment decision in relation to any securities.
Biocell Center Group Roberto Scarafia – Member of the Board 10