Scaffold-free cell-based tissue engineering therapies: advances, shortfalls and forecast

Pieri, Andrea De; Rochev, Yury; Zeugolis, Dimitrios I.

doi:10.1038/s41536-021-00133-3

Cited by 110 publications

(83 citation statements)

References 225 publications

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“…for numerous applications [60]. This success attests to the potential of living materials in translational activities and stimulates continuous efforts in this field to develop alternative iterations of these systems that will eventually find their place in the clinic.…”

Section: Progress On Living Materials As Therapeutic Platforms For Tissue Engineeringmentioning

confidence: 98%

Engineering mammalian living materials towards clinically relevant therapeutics

2021

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Section: Progress On Living Materials As Therapeutic Platforms For Tissue Engineeringmentioning

confidence: 98%

Engineering mammalian living materials towards clinically relevant therapeutics

2021

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“…Current scaffold-based cellular products with FDA approval are used for the treatment of diabetic foot ulcers (e.g., Apligraf R , Dermagraft R ), burns (OrCel R ), and mucogingival conditions (GINTUIT) (9,24,171,172). Scaffold-free cellular products are tissue analogs that are densely populated with cells carried and protected by their secreted, tissue-specific extracellular matrix (ECM) (9). This biotechnology can employ temperature-responsive polymers (e.g., pNIPAM, PVME) that transition between hydrophobic and hydrophilic states at certain temperatures, allowing the control of cell culture and growth and subsequently the deposition of ECM and the formation of cell sheets that adhere to biological surfaces (173)(174)(175).…”

Section: Scaffold-based or -Free Cellular Productsmentioning

confidence: 99%

“…Cell therapy combines stem cell-and non-stem cell-based unicellular or multicellular therapies. It typically employs autologous or allogeneic cells; might involve genetic engineering or manipulations in formulation; and can be administered topically or as injectables, infusions, bioscaffolds, or scaffold-free systems (5)(6)(7)(8)(9). Cell therapy spans multiple therapeutic areas, such as regenerative medicine, immunotherapy, and cancer therapy.…”

Section: Introductionmentioning

confidence: 99%

Cell Therapy: Types, Regulation, and Clinical Benefits

2021

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Cell therapy practices date back to the 19th century and continue to expand on investigational and investment grounds. Cell therapy includes stem cell- and non–stem cell-based, unicellular and multicellular therapies, with different immunophenotypic profiles, isolation techniques, mechanisms of action, and regulatory levels. Following the steps of their predecessor cell therapies that have become established or commercialized, investigational and premarket approval-exempt cell therapies continue to provide patients with promising therapeutic benefits in different disease areas. In this review article, we delineate the vast types of cell therapy, including stem cell-based and non–stem cell-based cell therapies, and create the first-in-literature compilation of the different “multicellular” therapies used in clinical settings. Besides providing the nuts and bolts of FDA policies regulating their use, we discuss the benefits of cell therapies reported in 3 therapeutic areas—regenerative medicine, immune diseases, and cancer. Finally, we contemplate the recent attention shift toward combined therapy approaches, highlighting the factors that render multicellular therapies a more attractive option than their unicellular counterparts.

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“…Currently, tools are being developed to automate terrestrial cell culture (Cohen-Karlik, E., et al 2021) and biofabrication methods (De Pieri, A., et al 2021). These automated technologies could be applied to research in the LEO environment, allowing experiments to run autonomously and potentially scale in the progression from research to clinical applications (Vieira, C. P., et al 2021).…”

Section: Automation Artificial Intelligence and Machine Learningmentioning

confidence: 99%

Opportunities for Biomanufacturing in Low Earth Orbit: Current Status and Future Directions

Giulianotti¹,

Sharma²,

Clemens³

et al. 2021

Preprint

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In humankind’s endeavor to explore beyond our planet and travel further into space, we are now at the threshold of an era in which it is possible to move to and from low Earth orbit (LEO) with increasing ease and reduced cost. Through the International Space Station (ISS) U.S. National Laboratory, investigators from industry, academia, and government can easily access the unique LEO environment on the ISS to conduct research and development (R&D) activities in ways not possible on Earth. A key advantage of the LEO environment for life sciences research is the ability to conduct experiments in sustained microgravity conditions. The ability to conduct long-term research in microgravity enables opportunities for novel, fundamental studies in tissue engineering and regenerative medicine, including research on stem cell proliferation and differentiation, biofabrication, and disease modeling using microphysiological systems (MPS) that build on prior research using simulated microgravity conditions (Grimm, D., et al. 2018). Over the last decade, space-based research has demonstrated that microgravity informs our knowledge of fundamental biology and accelerates advancements in health care and medical technologies (International Space Station 2019). The benefits provided by conducting biomedical research in LEO may lead to breakthroughs not achievable on Earth. We are now at a transition point, in which nations are changing their approach to space-based R&D. The focus is shifting from government-funded fundamental science toward the expansion of privately funded R&D with terrestrial application and economic value that will drive a robust marketplace for innovation and manufacturing in LEO. Making this long-term transition requires public-private participation and near-term funding to support critical R&D to leverage the benefits of the LEO environment and de-risk space-based research. Studies conducted on the ISS over the past several years have indicated that one area with potential significant economic value and benefit to life on Earth is space-based biomanufacturing, or the use of biological and nonbiological materials to produce commercially relevant biomolecules and biomaterials for use in preclinical, clinical, and therapeutic applications. We must take advantage of the remaining lifetime of the ISS as a valuable LEO platform to demonstrate this economic value and Earth benefit. By facilitating access to the space station, the ISS National Lab is uniquely positioned to enable the R&D necessary to bridge the gap between the initial discovery phase of space-based biomedical research and the development of a sustainable, investment-worthy biomanufacturing market in LEO supported by future commercial platforms. Through a joint effort, the Center for the Advancement of Science in Space (CASIS), which manages the ISS National Lab, and the University of Pittsburgh’s McGowan Institute for Regenerative Medicine brought together thought leaders from around the U.S. for a Biomanufacturing in Space Symposium that consisted of a series of working sessions to review data from past space-based tissue engineering and regenerative medicine research, discuss relevant current space-based R&D in this area, and consider potential future markets to address the questions: What are the most promising opportunities to leverage the ISS to advance space-based biomanufacturing moving forward? What are the current gaps or barriers that, if overcome, could clear pathways toward private investment in LEO as a valued site for research, development, and production activity? And, most importantly: For which opportunities do the most compelling value propositions exist? The goal of the Biomanufacturing in Space Symposium was to help identify the specific areas in which government and industry investment would be most likely to stimulate advancements that overcome barriers. This would lead to a more investment-ready landscape for private interests to enter the market and fuel exponential growth. The symposium was meant to serve as the first step in developing a roadmap to a sustainable market for biomanufacturing in space. The symposium identified and prioritized multiple key R&D opportunities to advance space-based biomanufacturing. These opportunities fall in the areas of disease modeling, stem cells and stem-cell-derived products, and biofabrication. Additionally, symposium participants highlighted the critical need for additional data to help validate and de-risk these opportunities and concluded that approaches such as automation, artificial intelligence (AI), and machine learning will be needed to produce and capture the required data. Symposium participants also came to a consensus that public-private partnerships and funding will be needed to advance the opportunities toward a biomanufacturing marketplace in LEO. This paper will summarize the current state of the science and technology on the ISS and in the fields of tissue engineering and regenerative medicine; provide an overview of biomanufacturing R&D in space to date; review the goals of the Biomanufacturing in Space Symposium; highlight the key commercial opportunities and gaps identified during the symposium; provide information on potential market sizes; and briefly discuss the next steps in developing a roadmap to biomanufacturing in space.

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Scaffold-free cell-based tissue engineering therapies: advances, shortfalls and forecast

Cited by 110 publications

References 225 publications

Engineering mammalian living materials towards clinically relevant therapeutics

Engineering mammalian living materials towards clinically relevant therapeutics

Cell Therapy: Types, Regulation, and Clinical Benefits

Opportunities for Biomanufacturing in Low Earth Orbit: Current Status and Future Directions

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