Replacement of dead or dysfunctional cardiac myocytes through disruptive cell-based therapies has become an emerging and exciting strategy for the treatment of heart failure through organ regeneration. However, there are many challenges that should be addressed during the process of cell generation and characterization in preclinical testing as a prelude to clinical testing. For these tests, highly viable and functional stem cell derived cardiomyocytes will have greater potential to regenerate and execute extensive repair after myocardial infarction. With the preliminary results of technical feasibility of a label- free electrical field potential marker based purification of induced pluripotent stem cells derived cardiomyocytes, Biopico systems Inc has increased hope for revolutionary regenerative treatments for heart diseases through preclinical testing. In this Small Business Innovation Research effort, Biopico will further develop its `on the fly single cell based electrophysiological sorting' system as a high specific and throughout front-end tool to focus on the preclinical clinical market. With the establishment of an effective functional electrophysiological marker based separation method to isolate differentiated cardiomyocytes exhibiting voltage gated ion-channels, a major milestone to sort and validate the cells for preclinical studies will be achieved. The focus of this effort will be to develop a commercial system with optimized and scaled up performance. This Cellular Electrophysiological Purification Array system will be developed to deploy in preclinical studies that will bring revenues through partnerships and sales. To accomplish this commercialization, Biopico Systems Inc has teamed up with academic and industry collaborators for validating the label-free cell sorting system for preclinical market. With the value proposition to sort therapeutic cells at high specificity, viability and functionality, the system will have applications in preclinical testing for patient's safety, therapeutic efficacy and engrafting.
Public Health Relevance Statement: Project narrative: The development of a novel label free high-throughput iPSC sorting technology of Biopico systems Inc will contribute to the development of highly innovative tools and technology for analysis of single cells. The sensitive detection of potentially tumorigenic cells at the single cell level and development of appropriate preclinical immune models, will permit more effective translation of experimental approaches to human procedures. This contribution can provide new in vitro models to study disease mechanisms, screening tools for toxicology testing, and therapeutic drugs to reverse disease phenotypes. Our endeavor to evaluate and optimize preclinical therapies can overcome the barriers that prevent successful translation of advances in regenerative stem cell biology to restoring cardiac function and survivability in the failing heart.
Project Terms: Address; Amplifiers; base; Cardiac; Cardiac Myocytes; Cell Differentiation process; Cell physiology; Cell Separation; Cell Therapy; Cells; Clinical; commercialization; Custom; Data; Derivation procedure; design; Detection; Development; Differentiation Antigens; Dimensions; disease mechanisms study; disease phenotype; Electric Stimulation; Electrodes; Electronics; Electrophysiology (science); Ensure; epigenetic marker; Exhibits; Feasibility Studies; Felis catus; Gated Ion Channel; Gene Expression; Generations; genetic analysis; Goals; Heart; Heart Diseases; Heart failure; heart function; Human; Immunological Models; Immunologics; improved; in vitro Model; Incubators; induced pluripotent stem cell; Industrialization; Industry Collaboration; Injections; innovation; Ion Channel Gating; Label; Legal patent; Liquid substance; Literature; machine vision; Measurement; Methods; Microfluidics; Molds; Multivariate Analysis; Myocardial Infarction; Natural regeneration; novel; off-patent; operation; organ regeneration; patient safety; Patients; Performance; Pharmaceutical Preparations; Phase; pluripotency; portability; pre-clinical; pre-clinical therapy; preclinical study; Preclinical Testing; prevent; Procedures; Protocols documentation; Pump; regenerative; regenerative therapy; repaired; research clinical testing; response; Response to stimulus physiology; Sales; Sampling; scale up; Screening procedure; Sensitivity and Specificity; Services; Signal Transduction; single cell analysis; Site; Small Business Innovation Research Grant; Somatic Cell; Sorting - Cell Movement; Specificity; Speed; stem cell biology; Stem cells; sterility testing; success; System; Techniques; Technology; Testing; Therapeutic; Time; tissue culture; tool; Toxicology; Translations; Treatment Efficacy; treatment strategy; tumorigenic; Universities; Validation; voltage; wasting
