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Please Note: The technology listed below is not available to the public at this time. This technology is in the early stage of research and requires further development before it is ready for the marketplace. The VA is currently in the process of identifying potential companies who may be interested in licensing and/or further developing the technology through Cooperative Research and Development Agreements (CRADA). Through cooperative research initiatives such as these, it is our hope and goal that commercial products will be fully developed and made available to benefit veterans and others.  

VA TECHNOLOGY OPPORTUNITY BRIEF

Isolation and Characterization of Human Marrow-Isolated Adult Multipotent Inducible (MIAMI) Cells

(02-124)

OPPORTUNITY:
The Department of Veterans Affairs (VA) is seeking a commercial partner through a Cooperative Research & Development Agreement (CRADA) to further develop a novel procedure for isolating, from persons of all ages, a population of newly identified human primitive adult cells (MIAMI cells) with the capacity to differentiate toward a large variety of cell and tissue types found in the human body. The subject technology also provides a novel composition of matter, which can differentiate into a broad range of cells of mesodermal-, endodermal- and ectodermal-derived lineages to treat a variety of diseases.

TECHNOLOGY OVERVIEW:
Because they transform into specialized cells, stem cells have potential in many different areas of health and medical research, especially in the generation of cells and tissues for therapeutic purposes.

Currently, diseased or destroyed organs and tissues are often replaced with donated organs and tissues. However, the number of people awaiting transplants greatly exceeds the number of available donor organs. Stem cells offer the possibility of a renewable source of replacement cells and tissues to treat many diseases, conditions and disabilities, including Parkinson's and Huntington's diseases, spinal cord injury, stroke and vascular diseases, burns, heart disease, diabetes, fractures, bone lost to trauma or disease, osteoarthritis and rheumatoid arthritis.

The only type of stem cells currently used for therapy is hematopoietic stem cells (HSCs), blood-forming stem cells in bone marrow. Transfer of HSCs in bone-marrow transplants has been a clinical practice for many years. More advanced techniques of collecting or harvesting HSCs now are used to treat leukemia, lymphoma and several inherited blood disorders.

Pluripotent stem cells, which can produce any type of cell in the body except those needed to develop a fetus, have been isolated from human embryos that are a few days old. These cell types include those found in tissues and organs from all three germ layers of the early embryo, comprising the endodermal, mesodermal and ectodermal lineages. These stem cells are used to create pluripotent stem cell lines, cultures that can be grown indefinitely in the laboratory. Multipotent stem cell lines, cells capable of long-term self-renewal and of differentiation into multiple cell types, generally within the same lineage, also have been developed from fetal tissue obtained from terminated pregnancies.

The subject technology, on the other hand, isolates stem cells from post-natal and adult tissues. Thus far, such cells have been multipotent.

The subject technology provides a novel composition of matter, which can differentiate into a range of cells of mesodermal-, endodermal- and ectodermal-derived lineages to treat a variety of diseases. The technology also provides a unique and novel procedure for isolating, from persons of all ages, a population of newly identified human primitive adult cells (MIAMI cells) with the capacity to differentiate toward a large variety of cell and tissue types found in the human body. The MIAMI cells are derived from an easily accessible source such as bone marrow, and they can be expanded to the desired mass and subsequently differentiated toward desired cell or tissue lineages, such as bone, cartilage, neurons or pancreatic islets. In these states, the cells can be utilized in autologous cellular therapies and tissue-engineering strategies tailored specifically to an individual, regardless of age, to repopulate or repair damaged, aged or diseased organs and tissues.

TECHNICAL MERIT:
The greatest advantage claimed for the subject technology is that it isolates a defined normal population of primary cells and expands them in sufficient numbers to produce stable cell types belonging to endodermal-, mesodermal- and ectodermal-derived lineages ideal for cellular therapy uses from an adult rather than an embryo source. While other research efforts work with adult bone marrow, the subject technology's novel methods are claimed to provide enhanced rates of production. In addition, by working with stem cells derived from adult human bone marrow, this technology avoids the controversy surrounding the use of human embryo-derived cells. By the use of autologous cells, the risks of disease transmission and immunological complications are virtually eliminated. Moreover, the subject technology allows for the isolation of these cells from cadaveric sources, including tissues underutilized in transplantation such as vertebral bodies.

POTENTIAL APPLICATION:
The subject technology ultimately may prove useful in the repair of damaged or diseased organs and tissues. The technology also may be used as a cell replacement therapy or in tissue engineering to treat many diseases, conditions and disabilities including Parkinson's and Huntington's diseases, spinal cord injury, stroke and vascular diseases, burns, heart disease, diabetes, fractures, bone lost to trauma or disease, osteoarthritis and rheumatoid arthritis.

PATENT STATUS:
A US provisional patent application was filed on January 30, 2003 (60/443,572)
An International patent application was filed on January 29, 2004 (PCT/US04/02580)
Federal register: July 29, 2004 (Vol. 69, Number 145) p. 45373-45374
A US non-provisional patent application was filed on July 28, 2005 (10/544,021).
A provisional patent application was filed on Sept 11, 2007 (60/971,448)
A PCT application was filed on Sept 11, 2008 (awaiting S/N)

FOR MORE INFORMATION CONTACT:
Saleem Sheredos
Program Manager
Technology Transfer Program
Veterans Affairs
Office of Research & Development (12TT)
5th Floor
103 South Gay Street
Baltimore, MD 21202
202-380-5080
Fax 410.962.2141
e-mail: saleem.sheredos@va.gov

Last Updated  September 23, 2008