The two-year, $4.6 million contract with Cytori Therapeutics Inc. of San Diego is part of an effort by ASPR’s Biomedical Advanced Research and Development Authority (BARDA) to develop new medical products that treat illnesses associated with a radiological or nuclear emergency. These emergencies include the detonation of a nuclear bomb or improvised nuclear device.

 

In a radiological or nuclear emergency, people are likely to have combined injuries involving trauma, radiation, and thermal burns. Nuclear bombs and improvised nuclear devices can emit intense heat, potentially resulting in severe burns that can cover part or all of the body, as well as  creating radiation injury. Such severe thermal burns typically require several months of treatment and recovery, including surgery to graft skin from one part of the body to the affected area.

 

Under the contract, Cytori Therapeutics will evaluate its next generation regenerative medical technology, the Celution system, for generating cells found in fat tissues that can help healing. These cells are called adipose-derived regenerative cells, or ADRCs. The work will determine if ADRCs recovered after radiation exposure could remain useful and improve healing of thermal burn injuries. Cytori also is developing this technology for other regenerative medical applications, including repairing cardiovascular tissue.

 

If the initial study results are promising, BARDA may continue supporting development the system through clinical studies that could use this technology to treat severe thermal burns from conventional fires. Under the project, Cytori Therapeutics will seek regulatory approval for use of its product for thermal burns. The contract can be extended up to five years and up to a total of $106 million.

 

“The Cytori technology is promising, cutting edge science in regenerative medicine with multiple applications including the possible treatment of radiation injury,” said BARDA Director Robin Robinson, Ph.D. “BARDA is excited to be on the frontier of this technology that may serve everyday health care and emergency responses including radiation-associated illnesses.”

 

This contract is part of a broader BARDA effort to develop products for thermal burn injuries and for use in combined injuries likely in mass casualty situations. This line of product development is the latest in BARDA’s portfolio of advanced research and development contracts that generally have focused on development of medical countermeasures for treating acute radiation syndrome resulting from bone marrow, lung, gastrointestinal and skin injuries caused by damaging levels of radiation. 

 

This approach recognizes that health care providers will need a variety of effective ways to diagnose and treat the wide range of illnesses and injuries resulting from a radiological or nuclear incident.

 

Many of the products that BARDA is developing may find uses outside of emergency medicine, especially in the case of severe thermal burns. The development of such medical products improves the nation’s preparedness by increasing the number of products available for emergencies. With multiple uses, the market for these emergency products can be sustained because the products also can be used in day-to-day situations.

 

BARDA is seeking additional proposals for products that could be used to treat illnesses and injuries caused by high levels of radiation.  BARDA is also interested in proposals for improved diagnostic tools that could measure an individual’s absorbed radiation dose following a nuclear denotation or radiation accident.  Proposals are accepted through the current Broad Agency Announcement, BARDA-CBRN-BAA-12-100-SOL-00011, at the Federal Business Opportunities website (www.fbo.gov).

 

BARDA, an agency within HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR), provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats.  These threats include chemical, biological, radiological, and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases.

 

HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. To learn more about HHS, visit www.hhs.gov.

 

ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov.

 

For more information about BARDA and the advanced research and development of medical countermeasures, visit www.medicalcountermeasures.gov. Contract opportunities and awards are announced at www.fbo.gov.

 

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