Tissue engineering currently has little discipline in assessing the efficacy of biomaterials through in vivo experiments. This lack of discipline poses a serious challenge to the community as it will soon be inundated with scaffold biomaterials and alternative progenitor and stem cells. The community needs to establish a systematic way of evaluating which combination of scaffolds and progenitor/stem cells may result in most desirable wound repair. Three requirements for establishing such systematic evaluation platform are: (i) the capability to visualize the physiological changes occurring within the wound repair region, (ii) the capability to translate the visualized changes into objectively quantifiable measures, and (iii) the capability to deliver the analysis outcome in a matter that is user friendly and amenable to analysis provenance for the investigators. This proposal is a joint endeavor that combines the unique in vivo expertise available at the University of Connecticut Health Center and the advanced image processing and software engineering capability of CyberConnect. We propose a three-step approach that tests the feasibility of establishing a scaffold evaluation enterprise. First, we develop an in vivo standardized model for evaluation which using GFP reporters and cell specific enzymatic stains that can explain why one scaffold/cell combination is better than another. Second, we develop image analysis methods that can automatically quantify marker distributions to substantiate observable cellular events over the varying timeline. We also develop the needed LIMS and the associated database necessary to deposit images, analysis outcomes and the reports. Third, we beta test our strategy with two outside investigators who submit scaffold samples and benchmark our proposed operation to develop the optimal service model plan. The potential impact of our proposed work could be enormous. As the regenerative medicine market is expected to skyrocket in the coming years, a majority of biomaterial companies and stem cell companies will need to evaluate cell/scaffold combinations. Furthermore our evaluation technique could impact the FDA, as the current lack of regulatory standards for a cell based therapy is due to the difficulty of reliably scoring differentiation status of the donor cells and the response of the host cells to the intervention. Our proposed scaffold evaluation truly represents an untapped market.
Public Health Relevance: Our proposed framework could fundamentally change the way scientists develop cell therapy techniques in the future. Specifically, using the developed methodology the FDA could institute a new pre-clinical data collection policy which can assure safer, faster and more efficient cell therapies. The tissue engineering educational community can also greatly benefit from our research, as our effort can produce a standardized way of comparing scaffolds for their uses in wound repair protocols. As for the specific impact on the science, our proposed framework could produce a gold standard for evaluating the efficacy of scaffolds through in vivo experiments.
Public Health Relevance Statement: Perceived societal, educational, and scientific
Benefits: Our proposed framework could fundamentally change the way scientists develop cell therapy techniques in the future. Specifically, using the developed methodology the FDA could institute a new pre-clinical data collection policy which can assure safer, faster and more efficient cell therapies. The tissue engineering educational community can also greatly benefit from our research, as our effort can produce a standardized way of comparing scaffolds for their uses in wound repair protocols. As for the specific impact on the science, our proposed framework could produce a gold standard for evaluating the efficacy of scaffolds through in vivo experiments.
NIH Spending Category: Bioengineering; Biotechnology; Dental/Oral and Craniofacial Disease; Regenerative Medicine
Project Terms: Address; Area; Articulation; Au element; Benchmarking; Best Practice Analysis; Biocompatible Materials; Biology; Biomaterials; Biotechnology; Bone Formation; Categories; Cell Therapy; Cells; Classification; Client; Clinical Data; Communities; Computer Software Development; Computer Software Engineering; Connecticut; Data; Data Banks; Data Bases; Data Collection; Databank, Electronic; Databanks; Database, Electronic; Databases; Deposit; Deposition; Discipline; Effectiveness; Engineering, Software; Evaluation; Event; FLR; Failure (biologic function); Future; Goals; Gold; Health; Image Analyses; Image Analysis; Immune response; Institutes; Intervention; Intervention Strategies; Investigators; Joints; Mammals, Mice; Marketing; Measures; Method LOINC Axis 6; Methodology; Methods; Methods and Techniques; Methods, Other; Mice; Modeling; Mother Cells; Murine; Mus; NIH Program Announcements; Operation; Operative Procedures; Operative Surgical Procedures; Osteogenesis; Outcome; Phase; Physiologic; Physiological; Policies; Progenitor Cells; Program Announcement; Protocol; Protocols documentation; RFP; ROC Analysis; Regenerative Medicine; Reporter; Reporting; Request for Proposals; Research; Research Personnel; Researchers; SBIR; SBIRS (R43/44); Safety; Sampling; Science; Scientist; Services; Skeleton; Small Business Innovation Research; Small Business Innovation Research Grant; Software Engineering; Sound; Sound - physical agent; Staining method; Stainings; Stains; Stem cells; Surgical; Surgical Interventions; Surgical Procedure; Systematics; Techniques; Testing; Therapy, Cell; Time; TimeLine; Tissue Engineering; Translating; Translatings; Universities; Vascularization; Work; Wound Healing; Wound Repair; cell-based therapy; clinical data repository; clinical data warehouse; craniofacial; craniofacies; data repository; engineered tissue; experiment; experimental research; experimental study; failure; host response; image evaluation; image processing; immunoresponse; in vivo; innovate; innovation; innovative; interventional strategy; language translation; pre-clinical; preclinical; progenitor; public health relevance; relational database; repair; repaired; research study; scaffold; scaffolding; sound; surgery; tissue repair; user-friendly
