Description:
OBJECTIVE: Develop a low cost, handheld tool that fully integrates the process from fat tissue harvest to high quality stem cell product, enabling point of care application of adipose derived stem cell therapy. DESCRIPTION: Adipose derived stem cells, in particular the stromal vascular fraction (SVF), are attractive for regenerative medicine applications because of the ease of accessibility, multipotency of the cells, and avoidance of ethical issues. The current process for extracting, isolating, and processing of adipose derived stem cells has limitations including processing time and size of the instrument. These limitations also impact the workflow of the surgeon in providing novel cell therapy for point of care applications. Therefore, development of a handheld tool that could streamline and integrate the collection and the subsequent processing of adipose lipoaspirate tissue to result in a sterile, concentrated stem cell product ready for use will enable applications of cell therapy at point of care. This SBIR topic seeks for a novel, integrated tissue and cell recovery system for rapid processing and recovery of desired regenerative cells with cell recovery from 5-20 million, with greater than 75% cell viability, and be free of fibrous material and cell debris. The solution also needs to address current technology limitations such as sterility breaks, acquisition and process time, complexity of operation, and cost. Development of this technology should provide for convenient and rapid extraction of millions of processed regenerative stem cells as a readily available source of adult stem cells for therapeutic applications to treat diseases and traumas such as Parkinson"s and wound repair respectively. Solution should take into consideration of the surgeon"s workflow and provide for an ergonomic design. The process design should not harm cells and provide for the highest number of stem cells recovered, resulting in a population of quality stem cells readily available for use. PHASE I: Conceptualize and design an innovative solution that meets the topic"s objective. Required Phase I deliverables will include concept design, schematic drawings, anticipated performance metrics for the device, specifications, plans for testing and evaluation for Phase II implementation, and a well-developed business model or plan for commercialization (this should include estimated manufacturing cost). No animal or human use testing is to be proposed or executed during this 6-month Phase I period. Cells should be from commercial sources (if from other methods of procurement requiring institutional regulatory approval, this must already be approved prior to proposal submission). PHASE II: Finalize design, development, and demonstration of proposed solution based on results from Phase I. This includes building a preliminary prototype for testing and evaluating the technical feasibility. The demonstration of proof-of-concept should confirm and/or establish performance metrics (e.g. cell processing time). Additional required Phase II deliverables will include design improvements to the prototype, demonstration in an operational setting, validation of cell extraction using standard assays and/or methods, determination of performance metrics including processing time and sterility confirmation, and a refined technology transition and/or commercialization plan including manufacturing and regulatory pathway (also provide an updated manufacturing cost). Statistical power should be adequate to document performance metrics. PHASE III: Phase III efforts should lead to 510K clearance or other appropriate regulatory approval and be focused towards technology transition, preferably commercialization of SBIR research and development. Efforts leading to 510K clearance or regulatory approval require execution of Phase II plans on commercialization and regulatory pathway. The small business should have in plans to secure funding from non-SBIR government sources and /or the private sector to develop or transition the prototype into a viable product for sale in the military and/or private sector markets. Commercialization plans that include the private sector markets generally help lower cost through economy of scale. REFERENCES: 1. JM Gimble, AJ Katz, BA Bunnell. Adipose-Derived Stem Cells for Regenerative Medicine. Circulation Research. 2007; 100:1249-1260. 2. S Lendeckel, A Jodicke, P Christophis, K Heidinger, J Wolff, JK Fraser, MH Hedrick, L Berthold, HP Howaldt. Autologous Stem Cells (Adipose) and Fibrin Glue Used to Treat Widespread Traumatic Calvarial Defects: Case Report. Journal of Cranio-Maxillofacial Surgery. 2004; 32(6):370-373. 3. PA Zuk, M Zhu, H Mizuno, J Huang, JW Futrell, AJ Katz, P Benhaim, HP Lorenz, MH Hedrick. Multilineage Cells from Human Adipose Tissue: Implications for Cell-Based Therapies. Tissue Engineering. 2001, 7(2): 211-228 4. MN Helder, M Knippenberg, J Klein-Nulend, PIJM Wuisman. Stem Cells from Adipose Tissue Allow Challenging New Concepts for Regenerative Medicine. Tissue Engineering. 2007, 13(8): 1799-1808. 5. MB Coelho, JMS Cabral, JM Krap. Intraoperative Stem Cell Therapy. Annual Review of Biomedical Engineering. 2012, 14:325-349
