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Needle to needle robot-assisted manufacture of cell therapy products.

ABSTRACT: Advanced therapeutic medicinal products (ATMPs) have emerged as novel therapies for untreatable diseases, generating the need for large volumes of high-quality, clinically-compliant GMP cells to replace costly, high-risk and limited scale manual expansion processes. We present the design of a fully automated, robot-assisted platform incorporating the use of multiliter stirred tank bioreactors for scalable production of adherent human stem cells. The design addresses a needle-to-needle closed process incorporating automated bone marrow collection, cell isolation, expansion, and collection into cryovials for patient delivery. AUTOSTEM, a modular, adaptable, fully closed system ensures no direct operator interaction with biological material; all commands are performed through a graphic interface. Seeding of source material, process monitoring, feeding, sampling, harvesting and cryopreservation are automated within the closed platform, comprising two clean room levels enabling both open and closed processes. A bioprocess based on human MSCs expanded on microcarriers was used for proof of concept. Utilizing equivalent culture parameters, the AUTOSTEM robot-assisted platform successfully performed cell expansion at the liter scale, generating results comparable to manual production, while maintaining cell quality postprocessing.

SUBMITTER: Ochs J

PROVIDER: S-EPMC9472012 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Needle to needle robot-assisted manufacture of cell therapy products.

Ochs Jelena J Hanga Mariana P MP Shaw Georgina G Duffy Niamh N Kulik Michael M Tissin Nokilaj N Reibert Daniel D Biermann Ferdinand F Moutsatsou Panagiota P Ratnayake Shibani S Nienow Alvin A Koenig Niels N Schmitt Robert R Rafiq Qasim Q Hewitt Christopher J CJ Barry Frank F Murphy J Mary JM

Bioengineering & translational medicine 20220806 3

Advanced therapeutic medicinal products (ATMPs) have emerged as novel therapies for untreatable diseases, generating the need for large volumes of high-quality, clinically-compliant GMP cells to replace costly, high-risk and limited scale manual expansion processes. We present the design of a fully automated, robot-assisted platform incorporating the use of multiliter stirred tank bioreactors for scalable production of adherent human stem cells. The design addresses a needle-to-needle closed pro ...[more]

PMID: 36176619

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Project description:BackgroundEffective rehabilitative therapies are needed for patients with long-term deficits after stroke.MethodsIn this multicenter, randomized, controlled trial involving 127 patients with moderate-to-severe upper-limb impairment 6 months or more after a stroke, we randomly assigned 49 patients to receive intensive robot-assisted therapy, 50 to receive intensive comparison therapy, and 28 to receive usual care. Therapy consisted of 36 1-hour sessions over a period of 12 weeks. The primary outcome was a change in motor function, as measured on the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke, at 12 weeks. Secondary outcomes were scores on the Wolf Motor Function Test and the Stroke Impact Scale. Secondary analyses assessed the treatment effect at 36 weeks.ResultsAt 12 weeks, the mean Fugl-Meyer score for patients receiving robot-assisted therapy was better than that for patients receiving usual care (difference, 2.17 points; 95% confidence interval [CI], -0.23 to 4.58) and worse than that for patients receiving intensive comparison therapy (difference, -0.14 points; 95% CI, -2.94 to 2.65), but the differences were not significant. The results on the Stroke Impact Scale were significantly better for patients receiving robot-assisted therapy than for those receiving usual care (difference, 7.64 points; 95% CI, 2.03 to 13.24). No other treatment comparisons were significant at 12 weeks. Secondary analyses showed that at 36 weeks, robot-assisted therapy significantly improved the Fugl-Meyer score (difference, 2.88 points; 95% CI, 0.57 to 5.18) and the time on the Wolf Motor Function Test (difference, -8.10 seconds; 95% CI, -13.61 to -2.60) as compared with usual care but not with intensive therapy. No serious adverse events were reported.ConclusionsIn patients with long-term upper-limb deficits after stroke, robot-assisted therapy did not significantly improve motor function at 12 weeks, as compared with usual care or intensive therapy. In secondary analyses, robot-assisted therapy improved outcomes over 36 weeks as compared with usual care but not with intensive therapy. (ClinicalTrials.gov number, NCT00372411.)

Project description:BackgroundMultiplayer games have emerged as a promising approach to increase the motivation of patients involved in rehabilitation therapy. In this systematic review, we evaluated recent publications in health-related multiplayer games that involved patients with cognitive and/or motor impairments. The aim was to investigate the effect of multiplayer gaming on game experience and game performance in healthy and non-healthy populations in comparison to individual game play. We further discuss the publications within the context of the theory of flow and the challenge point framework.MethodsA systematic search was conducted through EMBASE, Medline, PubMed, Cochrane, CINAHL and PsycINFO. The search was complemented by recent publications in robot-assisted multiplayer neurorehabilitation. The search was restricted to robot-assisted or virtual reality-based training.ResultsThirteen articles met the inclusion criteria. Multiplayer modes used in health-related multiplayer games were: competitive, collaborative and co-active multiplayer modes. Multiplayer modes positively affected game experience in nine studies and game performance in six studies. Two articles reported increased game performance in single-player mode when compared to multiplayer mode.ConclusionsThe multiplayer modes of training reviewed improved game experience and game performance compared to single-player modes. However, the methods reviewed were quite heterogeneous and not exhaustive. One important take-away is that adaptation of the game conditions can individualize the difficulty of a game to a player's skill level in competitive multiplayer games. Robotic assistance and virtual reality can enhance individualization by, for example, adapting the haptic conditions, e.g. by increasing haptic support or by providing haptic resistance. The flow theory and the challenge point framework support these results and are used in this review to frame the idea of adapting players' game conditions.

Project description:BackgroundSelecting and maintaining an engaging and challenging training difficulty level in robot-assisted stroke rehabilitation remains an open challenge. Despite the ability of robotic systems to provide objective and accurate measures of function and performance, the selection and adaptation of exercise difficulty levels is typically left to the experience of the supervising therapist.MethodsWe introduce a patient-tailored and adaptive robot-assisted therapy concept to optimally challenge patients from the very first session and throughout therapy progress. The concept is evaluated within a four-week pilot study in six subacute stroke patients performing robot-assisted rehabilitation of hand function. Robotic assessments of both motor and sensory impairments of hand function conducted prior to the therapy are used to adjust exercise parameters and customize difficulty levels. During therapy progression, an automated routine adapts difficulty levels from session to session to maintain patients' performance around a target level of 70%, to optimally balance motivation and challenge.ResultsRobotic assessments suggested large differences in patients' sensorimotor abilities that are not captured by clinical assessments. Exercise customization based on these assessments resulted in an average initial exercise performance around 70% (62% ± 20%, mean ± std), which was maintained throughout the course of the therapy (64% ± 21%). Patients showed reduction in both motor and sensory impairments compared to baseline as measured by clinical and robotic assessments. The progress in difficulty levels correlated with improvements in a clinical impairment scale (Fugl-Meyer Assessment) (r s = 0.70), suggesting that the proposed therapy was effective at reducing sensorimotor impairment.ConclusionsInitial robotic assessments combined with progressive difficulty adaptation have the potential to automatically tailor robot-assisted rehabilitation to the individual patient. This results in optimal challenge and engagement of the patient, may facilitate sensorimotor recovery after neurological injury, and has implications for unsupervised robot-assisted therapy in the clinic and home environment.Trial registrationClinicalTrials.gov, NCT02096445.

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Needle to needle robot-assisted manufacture of cell therapy products.

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Needle to needle robot-assisted manufacture of cell therapy products.

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