Manufacturing Parameters for the Creation of Clinical-Grade Human-Induced Pluripotent Stem Cell Lines From Umbilical Cord Mesenchymal Stromal Cells.

Induced pluripotent stem cells (iPSCs) are reprogrammed cells with a remarkable capacity for unlimited expansion and differentiation into various cell types. Companies worldwide are actively engaged in developing clinical-grade iPSC lines to address the needs of regenerative medicine, immunotherapies, and precision medicine. However, ensuring the safety and quality of iPSCs is essential, with adherence to Good Manufacturing Practices (GMP) and ethical considerations being paramount. Perinatal cell and tissue banks, such as umbilical cord (UC) blood and tissue banks, are emerging as ideal sources for generating iPSCs due to their unique characteristics and GMP compliance. These banks provide access to immature cells with limited environmental exposure, known family and medical histories of donors, and readily available resources, thereby reducing the time and cost associated with personalized treatment strategies. This study describes the establishment of the first clinical-grade iPSC lines from umbilical cord mesenchymal stromal cells in Brazil. The process involved rigorous quality control measures, safety assessments, and adherence to regulatory standards, resulting in iPSCs with the necessary characteristics for clinical use, including sterility, genomic integrity, and stability. Importantly, the study contributes to the development of a Current Good Manufacturing Practice-compliant iPSC production pipeline in Brazil, using commercially available, chemically defined, and xeno-free products, along with validation by national outsourced laboratories, thereby facilitating the adoption of this technology within the country. The study emphasizes Brazil's contribution to the progress of translational medicine and the promotion of scientific advancements within the field of regenerative and precision medicine.

A novel method to pack cryopreserved amniotic membrane for wound dressing-the pathway through validation of a new biological product.

Amniotic membrane (AM) has been widely used as a biological dressing for many pathologies and illnesses worldwide, and products derived from this tissue have been commercially available in several countries. In Brazil, regulatory agencies have recently authorized its clinical use as a non-experimental therapy for burns, diabetic and venous stasis ulcers, and intrauterine adhesions. In this study, we present our pathway through validating the first available service in the country of AM cryopreservation, with a protocol for long-term storage in high-efficiency nitrogen cryogenic freezers and a specific way of packing the tissue for optimal clinical handling and efficient storage space utilization while preserving live cells and the tissue's biological properties. Using gauze as support, cryoprotectant dimethyl sulfoxide and product presentation as a multilayer roll exhibited the best cell viability results and maintained the tissue integrity and presence of stem/progenitor cells. Essential proteins involved in tissue regeneration and immune and antimicrobial control were detected from the secretome of cryopreserved tissue similar to fresh tissue. Furthermore, immunogenic markers, such as human leukocyte antigens, were detected at very low levels in the tissue, confirming their low immunogenicity. Finally, we demonstrate that the tissue can be kept under refrigerated conditions for up to 7 d for further use, maintaining sterility and considerable cell viability. Our cryopreservation and storage protocol kept the AM viable for at least 20 months. In conclusion, this study enabled us to determine a novel efficient protocol for long-term AM preservation for future clinical applications.

Relocating to a new facility: The challenge of a cord blood banking transferral in Brazil.

BACKGROUND: Our cord blood banking facility planned and executed a transferral of its entire operation to a new site in the South of Brazil. Transporting LN2 freezers is a complex process in which extensive planning is essential to minimize the risks of damaging products or storage units. METHODS: To fulfill this objective, we constructed a detailed relocation plan consisting of four phases and risk mitigation measures, collaborated with the representatives of all departments, regulating agencies, and professionals from the transport company, and assembled a validation plan for cryogenic freezers and the viability of cord blood units. RESULTS: The new facility was prepared in accordance with the project plan, local legislation, quality system program requirements, and accreditation agency guidance. A 12-h operation of moving the cryogenic freezers was conducted successfully, with no loss or damage of client samples or equipment. CONCLUSION: Through the development and execution of a transferral plan, the engagement of appropriate partners, and compliance with security measures from health and government agencies, a successful transferral of a cord blood banking facility operation in its entirety can be successfully accomplished.

A construção da memória em vida: a participação do professor Germano Bayer na história da educação física paranaense / Construction of memory in life: the professor Germano Bayer participation in the history of physical education paranaense / Construcción de la memoria en la vida: la participación del profesor Germano Bayer en la historia de la educación física paranaense

A fim de compreender se a importância da construção da memória para o campo da História da Educação Física e identificar as dificuldades do pesquisador em determinar o que de fato tem valor histórico, foram analisadas fontes que remetem à Germano Bayer - professor e pesquisador, que teve considerável influência na Educação Física paranaense. A partir do levantamento de documentos e de entrevistas realizadas com três profissionais que, em algum momento, relacionaram-se com o acervo documental criado por Bayer. Ele fez questão de registrar de diversas formas momentos impactantes da sua carreira profissional, com o objetivo de registrar a sua atuação como educador físico, deixando de legado o seu acervo às gerações futuras de profissionais de Educação Física. A relação da construção de sua memória individual com as diversas pessoas que participaram dos fatos tornou, assim, sua memória, uma memória histórica, uma memória da Educação Física.

In order to understand the importance of the memory construction to the field of the Physical Education History and identify the difficulties of the research to determine what actually has historical value, sources were analyzed referring to Germano Bayer - teacher and researcher, had considerable influence Physical Education in Parana - From the survey documents and interviews with three professionals, at some point, were related to the collection created by Bayer. He made a point of recording, in various forms, moments as a professional, with the goal of creating a vision of the Physical Education and to bring its assets to the future generations. The relationship of the construction of his individual memory with the various people who participated in the events thus becomes his memory, contributing to the history of the Paranaense Physical Education.

Con el fin de entender la importancia de la construcción de la memoria para el campo da Historia da Educación Física e identificar las dificultades de lo investigador en determinar lo que realmente tiene valor histórico, fuentes fueron analizadas refiriendo a Germano Bayer - profesor e investigador que tuvo una influencia considerable en Educación Física del Paraná. A partir de la encuesta de documentos y entrevistas con tres profesionales que, en algún momento, eran relacionadas con el colección creado por Bayer. El insistió en registrar de diversas formas momentos impactantes de su carrera profesional, con el fin de registrar su actuación como educador físico, dejando el legado de su colección para futuras generaciones de profesionales de la Educación Física. La relación de el construcción de su memoria individual con las distintas personas que participaron de los hechos, hacerse, su memoria, una memoria histórica, contribuyendo a la historia de la educación física paranaense.

Estudo de um caso sobre a transferência erótica no setting psicanalítico

A transferência erótica foi um conceito elaborado por Freud, S....para designar o processo no qual o paciente, inconscientemente, repete seus protótipos infantis, ...... despertarem angústia. A gênese dos afetos encontra-se no complexo de Édipo, no qual afetos ambivalentes são direcionados às figuras parentais. Trata-se, portanto, da atualização de desejos inconscientes, no qual o paciente atua ao invés de recordar. Entretanto, ... uma vez que o paciente se desvia de si, investindo sua libido no analista, a fim de ... Concomitantemente, o analista pode reagir, de modo também inconsciente ....de contratransferência, o que torna a análise ainda mais complexa. Foi ao se deparar com a transferência erótica na prática clínica e com as dificuldades por ela erguidas, que esse trabalho surgiu, a fim de resgatar a teoria freudiana para identificar e compreender esse fenômeno,visando o prosseguimento e êxito do tratamento. Este estudo torna-se relevante não apenas para os profissionais da área da Psicologia, mas também para as demais áreas da saúde, visto que a transferência ocorre em diversos contextos e não apenas no setting analítico, embora seja esse o campo de atuação mencionado e estudado. Para ilustrar a teoria, será apresentado o caso quese tornou motivo desse trabalho. Por se tratar de um processo psicoterápico com referencial psicanalítico, o método consiste na observação clínica e escuta, caracterizando uma pesquisa qualitativa. Por fim, confirmamos as teorias propostas por Freud e constatamos a importância de resgatar a teoria, sobretudo, quando o tratamento psicoterápico é ameaçado por questões subjetivas do paciente ou do analista, a fim de não se desviar do real objetivo da análise: o paciente

The erotic transference was a concept developed by Freud, S .... to describe the process in which the patient unconsciously repeats his childish prototypes ...... wake anguish. The genesis of the emotions is the Oedipus complex, in which ambivalent emotions are directed to parental figures. It is therefore the update unconscious desires, in which the patient acts instead to remember. However, since ... deviates from the patient himself, his libido investing the analyst in order to ... Concomitantly, the analyst can react also unconsciously .... a counter, which makes analysis even more complex. It was when faced with erotic transference in clinical practice and the difficulties it raised, that this work came in order to rescue the Freudian theory to identify and understand this phenomenon, aiming at the continuation and success of treatment. This study becomes relevant not only for professionals in the area of ​​psychology, but also to other areas of health, as the transfer takes place in different contexts and not just in the analytic setting, although this is the mentioned field of activity and studied . To illustrate the theory, quese case has reason this work will be presented. For it is a psychotherapeutic process with psychoanalysis, the method consists of clinical observation and listening, featuring a qualitative research. Finally, we confirm the theories proposed by Freud and found the importance of rescuing the theory, especially when the psychotherapeutic treatment is threatened by subjective questions of the patient or the analyst, in order not to deviate from the real purpose of the analysis: the patient