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Alliance for Regenerative Medicine in Microgravity (ARM2)

 

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 healthcare.

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.

ARM2 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.

ARM2 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 ARM2 strategic plan.

The long-term vision of
ARM2 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.

ARM2 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 Earth.

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.”

 

ORGANOGENESIS

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 a transplant.
  • 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 infrastructure improvements.

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) culture medium.

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.

The 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 Culture

It 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

Developing Fetus

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 National Lab

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.

Subsequent funding 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.

 

THE TEAM:

 
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 Therapy Unit.

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 Morehead University.

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.

Prior 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 space experiments.

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 Obama.

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
 
Lawrence 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 programs.

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
 
Tamara Mandell is the Assistant Director for the Education and Training Programs at the University of Florida’s Center of Excellence for Regenerative Health Biotechnology.

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 Florida.

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 Management
 
Maria 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 programs.

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 program.

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
FreeFlight Creative
Director of Marketing and Public Relations
 
FreeFlight 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
FanManager
Marketing & Strategy Consultant
 
Erik 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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