Frequently Asked Questions

• What is the Armed Forces Institute of Regenerative Medicine?
• Which institutions make up AFIRM?
• How much funding is allocated to AFIRM?
• How were the AFIRM consortia chosen?
• When does the AFIRM program start?
• What sort of therapies will be developed within AFIRM?
• Will AFIRM researchers use embryonic stem cells?
• Can these stem cells regenerate entire arms and legs?
• What are tissue scaffolds?
• Are companies participating in AFIRM?
• How can other investigators participate in AFIRM?

 

What is the Armed Forces Institute of Regenerative Medicine?

A: The Armed Forces Institute of Regenerative Medicine is dedicated to repairing battlefield injuries through the use of regenerative medicine. The AFIRM is managed and funded through USAMRMC, with additional funding from the OASD(HA), ONR, USAF, the NIH, the VA, and local public and private matching funding.

Which institutions make up AFIRM?

A: AFIRM is a network of civilian research consortia coordinating and working with military institutions. In 2013, the consortium is led by Wake Forest University which manages a multi-institutional network of hospitals, academic laboratories, and industry partners.

How much funding is allocated to AFIRM?

A: AFIRM II is a $75M five year effort, with a period of performance starting in 2013. The first 5 years of the AFIRM had over $300M in funding. The U.S. government (to include OASD(HA)) contributed $125M, the consortia brought in local public and private matching funds amounting to more than $80 million, $109M came from existing research areas.

How were the AFIRM consortia chosen?

A: The cooperative agreements for AFIRM I and AFIRM II was a competitive solicitation process to a U.S. Army Program Announcement. The solicitation process for AFIRM II began in January 2010, with a Request for Information from USAMRMC. In 2011, a Program Announcement was released and over 12 consortia respond¬ed. The current awardee was selected in 2012 following a technical and programmatic review.

The solicitation process for AFIRM I began in January 2007, with a Request for Information from USAMRMC. Twenty-eight institutions responded. In April 2007, a draft Request for Proposal was sent to those 28 respondents for comment. In August 2007, a Program Announcement was released by the Army. Seven consortia respond¬ed. From those, two finalists were chosen for oral presentations to the Scientific Review Panel in December 2007. Ultimately, both finalists were deemed to have built excellent programs and both were recommended for funding.

When does the AFIRM program start?

A: Research activity under the AFIRM is under way at the individual participating institutions

What sort of therapies will be developed within AFIRM?

A: AFIRM was designed to speed the delivery of regenerative medicine therapies to treat the most critically injured service members. There are five major programs: Burn Repair, Craniofacial Reconstruction, Extremity Repair, Genitourinary Repair, and Composite Vascular Allotransplantation.

Will AFIRM researchers use embryonic stem cells?

A: No. All of the research now funded through AFIRM will use adult-derived stem cells taken from the patient or from another consenting adult. Adult stem cells and progenitor cells are an integral part of normal wound healing and the formation of all new tissues. Many of the strategies being developed by AFIRM seek to improve wound healing and tissue repair by increasing the number or improving the function of adult stem cells. A patient’s own cells or, in some cases, cells from another adult are used in conjunction with special drugs called bioactive factors, or with advanced biomaterials that serve as scaffolds for growth of new tissues.

Can these stem cells regenerate entire arms and legs?

A: No, at least not yet. However, the use of these cells, bioactive factors and bioma¬terials can help injured service members to optimize their own capacity to heal and recover by forming new bone, skin, nerves, tendons, muscles, and blood vessels to replace damaged tissues. The AFIRM collaborators plan to use these new strategies to dramatically speed and enhance the outcome of tissue repair, leading to a more ef¬fective return to productive life after injury.

What are tissue scaffolds?

A: Tissue scaffolds are the medical implants of the future: small, porous, tissue-like implants made of fully degradable, specially designed biomaterials that support cells at the site of injury and assist the body in growing new, functional tissue. When the damaged or lost tissue has been successfully replaced by new tissue, the scaffold will have been completely degraded and recycled by the body. Examples are regeneration of damaged or missing sections of bones, nerves, ligaments, blood vessels, and skin.

Are companies participating in AFIRM?

A: Dozens of commercial interests have expressed interest in working, and are working, with the AFIRM consortia as commercialization partners. The American medical device indus¬try has taken a keen interest in speeding these important new therapies to market, not just for injured service members but for civilian patients as well. Commercial participation is encouraged and this participa¬tion, ultimately, will lead to better health care options for all Americans.

How can other investigators participate in AFIRM?

The first contact should be with a member of the consortium. However, the USAMRMC has an open Broad Agency Announcement (BAA) intended to solicit extramural research and development ideas. The BAA is a competitive solicitation procedure issued under the provisions of the Competition in Contracting Act (CICA) of 1984 (Public Law 98-369). The BAA provides a general description of U.S Army Medical Research and Materiel Command's (USAMRMC's) research and development programs, including: research areas of interest; general information; evaluation and selection criteria; and proposal/application preparation instructions. Research funded through the BAA is intended and expected to benefit and inform both military and civilian medical practice and knowledge. Research proposal/applications are sought from national, international, for-profit, non-profit, public, and private organizations. The BAA is a continuously open announcement; pre-proposal/pre-applications and full proposal/full applications may be submitted at any time throughout the 12-month period. (See Federal Acquisition Regulations FAR 35.016). Program announcements also are published throughout the fiscal year to address specific topics in regenerative medicine.