Preclinical Development of Human Peripheral Nerve-Derived Therapeutic Products

Statement of Work Title: Preclinical Development of Human Peripheral Nerve-Derived Therapeutic Products Period: August 1st, 2022 – June 30th, 2023 Status of the grant: We are currently at middle term on the 3rd and last year of funding and our work is reaching completion. This grant is in no-cost extension (NCE) from July 1st, 2022 to June 30th, 2023. The scope of the work will remain the same as initially described in the NCE request submitted to the Indiana State Department of Health. Justification: We have performed a substantial proportion of the laboratory work during the prior 2 years of funding. Therefore, work in the third year will focus mostly on finalizing some critical experiments, performing bioinformatics analysis, and disseminating our research findings. Research dissemination. We have accomplished a total of 6 publications in top-tier, peer- reviewed journals in years 2022-2023. One of these papers has been recently published (Chau et al., Cell Transplantation, 2022), 3 have been submitted for publication (Bioprotocols, under review), and 2 of them are in different stages of preparation. Therefore, we expect our workload to be high as per the analysis and interpretation of our research data, the writing of the manuscripts, the preparation of the figures, and the submission of the papers. A modest budget for lab materials and services has been requested for ad hoc experimentation and general lab maintenance, as needed to complete, submit and revise the publications. Experimental work. This project depends on the casual availability of fresh human nerve samples from surgical procedures. Importantly, we shall continue to process new human nerve biospecimens at the pace they become available from our providing scientists for direct experimentation and/or storage by cryopreservation. In addition, work in collaboration with Dr. Lingxiao Deng (interim PI at IU) will allow us to incur in cell transplantation studies in animal models of spinal cord injury, and obtain preliminary data for future joint grant submissions with Dr. Deng’s team. Bioinformatics. It should be noted that considerable hours of work by Drs. Monje (PI at UK), Aparicio (Postdoctoral Associate, UK) and collaborators will be invested in in-silico work, as sophisticated bioinformatics analytical tools will be used to mine our RNAseq (bulk and single cell) and proteomics datasets for our improved understanding of the cellular and molecular constitution of human peripheral nerve tissues and nerve-derived cell types before and after injury or degeneration.