Alliance for Regenerative Medicine in
Facilitating Exploration and Discovery in Space-Based Regenerative Medicine
The human stem cell is a “silent warrior”
and the future is now ...
In history, scientific innovation and advancement is often marked by the
confluence of multiple opportunities.
The United States is currently experiencing such a convergence with the
aggressive advancement of the new commercial space industry, the advent of the
International Space Station (ISS) as a national research laboratory, and the
emergence of stem cell research as the next ‘breakthrough’ in clinical therapy
and treatment, poised to created unprecedented opportunities in human
The application of regenerative medicine and tissue engineering to treat human
disease is limited by our capacity to generate enough stem cells to achieve
effective therapy. This limitation is imposed by the cell’s environment as well
as conditions within the stem cell itself. As a result, there is no efficient
culture method to expand human stem cells in large quantities on earth. Previous
studies using simulated microgravity suggest both normal and cancer stem cells
proliferate faster in microgravity.
will support research that takes advantage of the microgravity and sterile
environment afforded by the ISS National lab to culture and expand clinical
grade stem cells.
intends to build on peer-reviewed initial flight
experimentation funded by CASIS. Data generated through this in-flight
experiment will be used to support subsequent studies aligned with the
The long-term vision of
includes the development of clinical applications
for a wide range of diseases and conditions; revolutionizing transplantation
accessibility through the unique capability of 3-D organogenesis; and
ultimately, providing the basis for understanding the processes and promoting
the advancement of unique strategies for the treatment of human cancers.
shall employ the new commercial space business model to support frequent,
regularly scheduled, cost effective access to space. We intend to devise and
develop flight hardware specifically designed to meet the requirements of the
full range of stem cell research possible onboard the ISS. Additionally,
individual members of the Alliance will provide professional development; direct
liaison with the Mayo Clinic, NASA, CASIS, other regenerative research
institutions, and space launch providers; and create a targeted marketing and
business strategy to help raise funds to support his new paradigm in medicine.
Foundational Development through
funding from CASIS:
The Center for the Advancement of Science
in Space (CASIS), a nonprofit organization that promotes research aboard the ISS,
in 2013, awarded Dr. Abba Zubair a $300,000 grant to send human stem cells into
space to observe if they grow more rapidly than similar stem cells grown on
Dr. Zubair, medical and scientific director of the Cell Therapy Laboratory at
Mayo Clinic in Florida, says the experiment will be the first one Mayo Clinic
has conducted in space and the first to use these non-embryonic human stem
cells, which are found in bone marrow.
“On Earth, we face many challenges in trying to grow enough stem cells to treat
patients,” he says. “It now takes a month to generate enough cells for a few
patients. A clinical-grade laboratory in space could provide the answer we all
have been seeking for regenerative medicine.”
He specifically wants to expand the population of stem cells that will induce
regeneration of neurons and blood vessels in patients who have suffered a
hemorrhagic stroke, the kind of stroke which is caused by blood clot. Dr. Zubair
already grows such cells in his Mayo Clinic laboratory using a large tissue
culture and several incubators -- but only at a snail’s pace. For example, a
patient needing a bone marrow transplant will need approximately 500,000,000
stem cells for the transplant which can take up to four months to grow.
Experiments on Earth using simulated microgravity have shown that stem cells --
the master cells that produce all organ and tissue cell types –
may expand at
a much greater rate than cells developed through conventional methods.
“If you have a ready supply of these
cells, you can treat almost any condition, and can theoretically regenerate
entire organs using a scaffold,” Dr. Zubair says.
“Additionally, they don’t need to come from individual patients -- anyone can
use them without rejection.”
Dr. Zubair is working with bioengineers
at the University of Colorado who are building the specialized cell bio-reactor
that will be taken to the ISS within a year for the experiment.
“I don’t really think growing cells in space for clinical use on Earth is
science fiction,” he says. “Commercial flights to the ISS will start soon, and
the cost of traveling there is coming down. We just need to show what can be
achieved in space, and this award from CASIS helps us do that.”
The ability to regenerate organs in
microgravity will impact the world ...
Imagine that you can create a new
heart, liver, kidney, lung or skin that will not be rejected by the patient.
Organs for transplant are difficult to obtain and the waiting list is often too
long. As an extension of the ARM² mission focused on regenerative medicine, we
support space-based research that may result in vastly improved organ
availability including the potential for banking autologous spare organs.
Specific organs could be customized by utilizing the patient’s own stem cells
and thereby eliminating many of the issues associated with current organ
transplantation including availability of suitable, matched organs and the onset
of graft-versus-host disease.
Current statistics from The American Transplant Foundation indicate that more
than 119,000 people in the United States are currently on the waiting list for
lifesaving organ transplant.
- Another name is added to the
national transplant waiting list every 12 minutes.
- On average, 19 people die every day
from lack of available organs for transplant.
- Seven percent of people on the
waiting list – more than 6,500 each year die before they are able to receive
- To date, 461,776 transplants have
occurred in the U.S. since 1988
Let’s use the example of a kidney
transplant. The U.S. averages approximately 15,000 kidney transplants annually at
an average cost of over $260,000, including about $70,000 for procurement of the
organ and $25,000 for immune-suppressants. Besides the monetary savings the
health benefits to the patient are priceless. Organs will be available for
patients so there is no waiting period. There is no chance of rejection. The
patient would not need to take immune-suppressants. A price point for a kidney
custom manufactured in microgravity of less than $90,000 would be a bargain.
Given the long waiting lists for organ transplantation, it is difficult, to
assign a cost to a customized transplant organ that might be readily available.
Additional long-term benefits will include the utilization of
microgravity-expanded stem cells in tissue manufacturing and organogenesis. Such
tissue may be “customized” for specific application or destination and will also
support the test and evaluation of emerging drug therapies. All processes and
therapies created or supported by this research might be introduced to the
market directly through institutions such as the Mayo system. The Mayo Clinic
has made regenerative medicine and individualized medicine among its top
priorities. As a consequence of this, a new Mayo Clinic Center for Regenerative
Medicine (CRM) was established in 2012. Its primary goal is to accelerate the
translation of stem cell research into clinical practice. CRM has already
committed over $3 million to Dr. Zubair’s Cell Therapy Laboratory for
How does this work?
The use of cells to repair and regenerate tissues and organs in medical practice
is growing. These cells are grown and expanded in two-dimensional tissue (2D)
This is not a natural condition for cell growth since cells grow
in three-dimensional (3D) medium tethered in multiple dimensions by connective
tissue and adhesion molecules inside the body.
perfect example is a human embryo. A developing fetus is buoyant in amniotic
fluid and that buoyancy minimizes the effect of gravity. Therefore, the ISS
National Laboratory microgravity environment will provide a more natural
condition for organ development.
2D Cell Growth in
is quite possible that microgravity will create a 3D suspense, mimicking the
natural growth condition in the body that facilitates cell growth and expansion.
We believe with the appropriate scaffolding and lack of gravitational forces,
organs can be better generated in microgravity than on earth.
3D Cell Growth in-vivo
And then there is perhaps
the most significant advancement …
Can we use the “C” word?
The stem cell research we support will have “world-changing” value arising from
the development of knowledge of the effects of microgravity on normal and cancer
stem cell biology. This knowledge may help to develop effective treatments and
possibly eradication strategies for many human cancers. The market value of such
research is difficult to assess but worthy of pursuit for its implications for
the common good.
Benefits of Using the ISS
We will support research
that takes advantage of the microgravity and relatively sterile environment
afforded by the ISS National Lab to culture and expand clinical grade organs for
transplantation. There already have been studies that suggest stem cells grow
better in simulated microgravity. We anticipate that this research can be
conducted in stages.
The initial stage is to
assess growth of human cells cultured in microgravity at the International
Space Station. The cultured cells will be characterized and evaluated for
their regenerative and functional capacities and their safe use in
experimental in-vivo models.
Follow-on studies might
evaluate if organs can be generated in microgravity. The generated organs
will be evaluated in experimental models for their function and safety. With
advances in technology and the aggressive advancement of the new commercial
space industry, the advent of the International Space Station as a national
laboratory, and the emergence of revolutionary space hardware, our support
for this ambitious research is both timely and appropriate.
is needed to continue research, develop flight hardware, provide additional
laboratory and ground support, facilitate launch services and build a strong
business model and fundraising platform.
Dr. Abba Zubair, M.D., Ph.D
Principal Investigator, Research Advisor
Dr. Zubair is the Director of Transfusion Medicine at the Mayo Clinic Florida
and associate professor at Mayo Clinic College of Medicine, Florida that
includes a Blood Bank that supports the largest liver transplant program in the
world, a state-of-the-art Clinical Apheresis Unit and a FDA certified Stem Cell
Dr. Zubair is a certified international inspector of bone marrow transplant
centers and blood banks for the Foundation for the Accreditation of Cellular
Therapy and the American Association of Blood Banks.
Dr. Zubair was educated at Ahmadu Bello University Medical School, Zaria
Nigeria. He studied homing and trafficking of human lymphoma cells at Sheffield
University Cancer Institute, England and obtained a PhD degree in Cancer
Immunobiology from the institute in 1995. Between 1995 and 1998, he worked as a
post-doctoral fellow in the laboratory of Dr. Paterson, University of
Pennsylvania on a project involving the use of recombinant Listera vaccines for
human papilloma virus related malignancies.
Dr. Zubair did his clinical residency at the Hospital of University of
Pennsylvania in Clinical Pathology and a fellowship in Transfusion Medicine at
the Join Program in Transfusion Medicine, Harvard Medical Center. Dr. Zubair
obtained a masters degree in Clinical trials and principles of drug development
at Harvard University and MIT. After his training he joined the Transfusion
Medicine Staff at Brigham and Women’s Hospital as a Clinical Instructor.
Dr. Zubair has authored and co-authored several scientific articles and book
chapters. His research interest is in the field of stem cell biology. He
currently conducts both NIH and industry-sponsored basic science and clinical
studies on stem cells.
Bob J. Twiggs, Professor of Space Science
Astronautical Engineer, Morehead University
Project Hardware Development
Project hardware development and integration efforts are led by Bob Twiggs of
Mr. Twiggs has long been a proponent of low-cost access to space and is
internationally recognized for his work in creating and advocating the CubeSat
concept upon which the NanoRacks model is based. Bob has ensured that the
attainment of knowledge, particularly by student participants at Stanford and
Morehead Universities is an integral element of every project.
Twiggs is currently a professor of Astronautical engineering at Morehead State
University in Kentucky. He joined Morehead State in July 2009 to assist in
the development of a Space Systems curriculum.
to that, he was a consulting professor in the Aeronautics and Astronautics at
Stanford University for 14 years.
He was responsible for developing the
curriculum for students interested in designing, building and operating small
He helped develop the original concepts for the CricketSat,
CanSat, CubeSat and the PocketQub for education applications for use in space.
In 2010 he was selected by the Space News publication as one of 10 space
professionals “That Made a Difference in Space.” The other two selected from the
United States were Elon Musk, CEO of SpaceX and the present US President, Barak
One of his recent publications is the co-author of the article “Citizen
Satellites” in the February 2011 Scientific American. He has a BS in Electrical
Engineering from the University of Idaho and an MS in Electrical Engineering
from Stanford University.
Lawrence Harvey, Director
Center for Applied Space Technology (CAST)
Project & Mission Management
Harvey is the Director of the Center for Applied Space Technology (CAST).
He brings his focus on the development and application of space-enabled
technologies and his experience in designing and managing significant aerospace
Mr. Harvey is a retired Naval Aviator with over 20 years of carrier-based flight
experience specializing in the employment of advanced technologies.
Besides extensive program and project management, his qualifications include
extensive ‘real world’ experience with satellite tracking and monitoring, space
technology applications, satellite imagery and interpretation, small payload
development and applications.
He established and led the initial Navy wide active duty combat search and
rescue (CSAR) program. He helped launch the Hubbs-SeaWorld Research Institute in
Florida where he developed the first significant ISS commercialization project.
The “SeaWorld Project” included the development of a marine vivarium for
on-orbit research supporting long-duration space flight and a high-performance
multi-spectral imager for mapping coastal waters and reefs.
He also established and led the non-for-profit Argos Foundation focused on the
promotion of the satellite service industry in the non-traditional fields of
education, environment (Centers for Space Oceanography), humanitarian, and
homeland security. He founded CAST with the objective of preserving and
advancing space technologies by repurpose and reapplication.
Tammy Mandell, Assistant Director,
University of Florida Center of Excellence for Regenerative Health Biotechnology
Education and Training
Mandell is the Assistant Director for the Education and Training Programs at the
University of Florida’s Center of Excellence for Regenerative Health
She received her BSE in Biology from the University of Kansas, and her M.Ed in
Curriculum and instruction with a focus on Biotechnology from the University of
She has over twelve years of academic research and industrial biotechnology
experience, primarily in the fields of molecular biology, biochemistry, and gene
therapy. She also has over seven years of experience in the development and
delivery of biotechnology-based training.
In partnership with CAST, she led the development and implementation of the
“AeroTech to BioTech” program, designed to supplement the workplace skills and
experience of aerospace technicians for employment in Florida’s bio-industry.
Tamara is fluent in the techniques and applications of methodologies in both
academic research and applied science, including the use and development of
assays, as well as the processes and quality systems utilized in manufacture of
cGMP compliant biopharmaceuticals.
Maria Peterson, Executive Director
Center for Applied Space Technology
Communications & Project
Peterson holds degrees from the University of Florida and Lamar University where
she earned her Master of Science in Organizational Communications.
She has also received considerable formal instruction in the fields of education
and communications through a variety of Government Professional Training
Maria has extensive experience in management, public relations, and marketing in
a wide-range of commercial and not-for-profit organizations.
She has had numerous opportunities to apply her skills by successfully executing
her responsibilities in such diverse enterprises as the oil industry, education,
military and government agencies.
Her knowledge, innovation, and resourcefulness have been instrumental in the
management of multi-million dollar budgets as well as the professional
development of hundreds of employees.
Maria was hand-picked to serve as the Executive Director of the Kennedy Space
Center Support Committee, an organization founded to support our nation’s space
She successfully liaised directly with members of the state and federal
government, including a large number of US Congressional members. Her
organizational and communication skills are exceptional and will be critical in
the fulfillment of the ARM² mission.
Bonnie Zimmermann, Producer
Director of Marketing and
Creative was established in 2008 by Bonnie to offer her clients viral and
traditional marketing, media, music and live event production on a global scale.
Her current clients include Transcendence Theater Company, Gregory Colbert, ARM²,
Center for Applied Space Technology and the Indonesian Parrot Project.
Past clients include The Harmony Festival,
Sonoma Country BBQ, Unseen Pictures, Kerner Music & Media/ILM (development of
3-D technology), United Earth Networks, Nobel laureates Rigoberta Menchu, Oscar
Arias, Betty Williams and Mikhail Gorbachev, and celebrities including Carlos
Santana, Steven Seagal, Judy Tenuta and David Copperfield.
In putting together this short bio she
realized she has no photographs of herself without a bird. She has been
championing the protection of endangered species of parrots in the wild since
2002 and written grants, conducted field studies and eco-expeditions in the
Peruvian Amazon and Indonesia.
Erik Koral, Owner & Founder
Marketing & Strategy
Koral is the owner and founder of FanManager, a full service digital marketing
firm based in Los Angeles, California founded in 2005.
With over 15 years of marketing experience,
Erik has worked with clients such as The Michael Jackson Estate, Intel, Shakira,
Depeche Mode, Columbia Pictures, Phish, Infected Mushroom, Victoria Justice,
Grace Potter, The Doors, Janis Joplin and many others.
Erik has also consulted for various 501
(c) 3 organizations such as Headcount, Rock the Earth, Electronic Music
Alliance, and the Immunity Project.
FanManager is completely honored to be
part of ARM².
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and change is inevitable …
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