Abstract
The discovery of reprogramming and generation of human-induced pluripotent stem cells (iPSCs) has revolutionized the field of regenerative medicine and opened new opportunities in cell replacement therapies. While generation of iPSCs represents a significant breakthrough, the clinical relevance of iPSCs for cell-based therapies requires generation of high-quality specialized cells through robust and reproducible directed differentiation protocols. We have recently reported manufacturing of human iPSC master cell banks (MCB) under current good manufacturing practices (cGMPs). Here, we describe the clinical potential of human iPSCs generated using this cGMP-compliant process by differentiating them into the cells from all three embryonic germ layers including ectoderm, endoderm, and mesoderm. Most importantly, we have shown that our iPSC manufacturing process and cell culture system is not biased toward a specific lineage. Following controlled induction into a specific differentiation lineage, specialized cells with morphological and cellular characteristics of neural stem cells, definitive endoderm, and cardiomyocytes were developed. We believe that these cGMP-compliant iPSCs have the potential to make various clinically relevant products suitable for cell therapy applications.
Highlights
Recent advances in the field of pluripotent stem cells (PSCs) and establishing specialized PSC derivatives have made a remarkable impact in understanding the biology of these cells and offered tremendous potential in personalized medicine for the treatment of degenerative diseases
We have previously reported the development of a current good manufacturing practices (cGMPs) manufacturing process to generate clinically compliant human induced pluripotent stem cells (iPSCs) lines and detailed characterization of these cells [13, 14]
These studies have addressed some of the challenges associated with manufacturing of high-quality iPSCs under cGMPcompliant conditions, including tissue sourcing, manufacturing, testing, and storage
Summary
Recent advances in the field of pluripotent stem cells (PSCs) and establishing specialized PSC derivatives have made a remarkable impact in understanding the biology of these cells and offered tremendous potential in personalized medicine for the treatment of degenerative diseases. The remarkable discovery of somatic cell reprogramming by Shinya Yamanka [1] has dramatically impacted the field of drug discovery, toxicity testing, in-a-dish disease modeling, gene therapy, and gene editing during the last decade [2, 3]. This is mostly due to enormous capability. Establishment of a robust directed differentiated procedure starting from high-quality cells manufactured using a robust and current good manufacturing practice (cGMP)-compliant process still remain a major challenge in enabling clinical utility of iPSC-based therapies. Inherent difficulties in achieving high-quality cGMP grade PSCs and their progenies is a major obstacle in cell-based therapy and should be overcome before these cell types can be used to treat diseases [13]
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