Research that uses amnion-derived multi-potent progenitor cells and their secreted cytokine solution to decrease loss of tissue, obtain more rapid wound closure, and decrease scarring in support of the Naval Medical Research Center, Silver Spring, MD

Notice of Intent to Sole Source The Naval Medical Logistics Command (NMLC) intends adding additional tasks onto current contract N62645-13-C-4014 under the authority of FAR 6.302-1 to Stemnion, Inc. 100 Technology Drive Suite 200, Pittsburgh, PA 15219 for a research and development (R&D) project in support of the Naval Medical Research Center (NMRC), Silver Spring, MD. The additional work will continue to build upon research that uses Amnion-derived multi-potent progenitor cells (AMP Cells) and their secreted cytokine solution (ACCS) to decrease loss of tissue, obtain more rapid wound closure and decrease scarring. The objective of this additional work is to obtain a novel cellular wound healing technology that will accelerate and improve healing of combat-related injuries and their associated chronic wounds. Applications include burn wounds, eye injuries, periodontal disease and therapies designed to strengthen suture sites. It is expected that the benefits of therapies developed to care for wounded servicemen and women will be immediately applicable to civilian patients across a broad spectrum of needs that range from burn victims to adults afflicted with the slow-healing wounds typical of Type II diabetes. The estimated period of performance for the additional work is 7 months. Stemnion's research group has conducted at least eight years of prior research and has the data and resources to support advancement of this effort. Stemnion currently controls 33 U.S. patents and 7 patents in other countries that are directly related to the AMP cell and ACCS cytokine solution therapies needed to continue this research project. The core research and development for AMP cells and ACCS cytokine solution has progressed to a first in-man clinical trial and they have currently undertaken a regimen of FDA human clinical trials. The additional effort includes: - Preparation & Development of Materials for Research & Clinical Trials - Bioreactor Production of ST266 - Develop Large-Scale Filtration and Treatment of ST266 - Develop an Extended-Life AMP Cell for Production of ST266 - Develop/Identify Assays to Establish Comparability of ST266 Produced Using Alternative Methods. A sources sought notice was issued on 18 May 2016 for this requirement and the Government determined after the review of capability statements, that no other source had the capability to perform the required work. This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 1 (8.5 x 11 inch) page and shall be submitted in 12 point, Times New Roman font. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract. Capability statements are due by 4:00 PM Local Time, 22 June, 2016. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: ronald.s.sanford2.civ@mail.mil.