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 the performance of 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 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 18 months.

Stemnion's research group has conducted at least six 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 and Development of Materials for Research and Clinical Trials
-Analytical assay development that ensure lot-to-lot reproducibility of ACCS and AMP Cells
-Immortalized cells development and production
-Facilities planning to expand ACCS production
-Immunology regarding the effect of AMP cells on Natural Killer and Natural Killer T cells and the effect of AMP cells on B lymphocytes.
-Formulation and Delivery of lyophilized and/or spray dried powder.
-Pre-clinical Animal Studies to evaluate ACCS control of systemic vascular permeability

A sources sought notice was issued on 18 May 2015 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 12:00 PM Local Time, 18 June, 2015. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: [email protected].

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