Thriving for the Renewal of Life: Present Needs in Cell Therapy Translational Research

2017 ◽  
pp. 325-339
Author(s):  
Asok Mukhopadhyay
Keyword(s):  
Cell Therapy ◽  
Translational Research

scholarly journals A few ethical issues in translational research for gene and cell therapy

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Luciana Riva ◽  
Carlo Petrini
Keyword(s):  
Gene Therapy ◽  
Cell Therapy ◽  
Translational Research ◽  
Early Phase ◽  
Ethical Issues ◽  
The United States ◽  
Cell Therapies ◽  
Biomedical Technologies ◽  
Regulatory Approach ◽  
Gene And Cell Therapy

Abstract Background Although translational research for drug development can provide patients with valuable therapeutic resources it is not without risk, especially in the early-phase trials that present the highest degree of uncertainty. With the extraordinary evolution of biomedical technologies, a growing number of innovative products based on human cells and gene therapy are being tested and used as drugs. Their use on humans poses several challenges. Methods In this work, we discuss some ethical issues related to gene and cell therapies translational research. We focus on early-phase studies analysing the regulatory approach of Europe and the United States. We report the current recommendations and guidelines of international scientific societies and European and American regulatory authorities. Results The peculiarity of human cell- or tissue-based products and gene therapy has required the development of specific regulatory tools that must be continually updated in line with the progress of the research. The ethics of translational research for these products also requires further considerations, particularly with respect to the specificity of the associated risk profiles. Conclusions An integrated ethical approach that aims for transparency and regulation of development processes, the support of independent judgment in clinical trials and the elimination of unregulated and uncontrolled grey areas of action are necessary to move gene and cell therapy forward.

scholarly journals Th17 Pathway As a Target for Multipotent Stromal Cell Therapy in Dogs: Implications for Translational Research

PLoS ONE ◽  
2016 ◽  
Vol 11 (2) ◽  
pp. e0148568 ◽  
Author(s):  
A. Kol ◽  
N. J. Walker ◽  
M. Nordstrom ◽  
D. L. Borjesson
Keyword(s):  
Cell Therapy ◽  
Translational Research ◽  
Stromal Cell ◽  
Multipotent Stromal Cell

Adoptive T-cell therapy combined with intra-lesional administrations of TG1042 (adenovirus expressing interferon-γ) in metastatic melanoma patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20022-e20022
Author(s):  
Amir Khammari ◽  
Jean-Marc Limacher ◽  
Jean-Michel NGuyen ◽  
Melanie Saint-Jean ◽  
Gaelle Quereux ◽  
...  
Keyword(s):  
T Cell ◽  
Adverse Events ◽  
Cell Therapy ◽  
Translational Research ◽  
Stable Disease ◽  
Objective Response ◽  
Interferon Γ ◽  
Adoptive T Cell Therapy ◽  
Surgical Biopsy ◽  
T Cell Therapy

e20022 Background: The purpose of this study was to evaluate the feasibility, safety and efficacy of adding intra-tumoral injections of TG1042 (Adenovirus 5 expressing Interferon-γ) to adoptive T cell therapy in patients with advanced stage melanoma. Methods: This was a monocentric phase I/II study. The main inclusion criteria were: stage IIIc/IV melanoma, age 18 to 75, at least one injectable metastasis. Tumor infiltrating lymphocytes (TILs) produced from a surgical biopsy of a lesion were infused on days 1 and 29 followed by IL2 injections (6M UI daily) for 10 days. TG1042 was injected at the dose of 5x1010 viral particles per lesion (in up to 6 lesions) every 2 weeks from day -15 to month 2 and then every month up to month 11 or progression. Primary objective was the safety of the procedure; secondary objectives included response according to RECIST and translational research. Results: Eighteen patients have been included. The TILs production was successful in 16 of them. Minor erythema at the TG1042 injection site as well as minor to moderate flu-like symptoms linked to IL2 injections were the most frequent adverse events observed. No grade 3 or 4 treatment related adverse events was recorded. Among the 13 patients evaluable for tumor response 4 patients (31%) had an overall objective response (2 complete, 2 partial), 1patient had a stable disease and 8 progressed. When considering only the injected lesions 6 (46%) had an objective response (3 complete, 3 partial), 3 had a stable disease and 4 progressed. Distant responses in non-injected lesions were observed for 2 patients. Translational research on cutaneous biopsies before and after injections (3 months) showed an increase of CD8 T lymphocytes, IFN-γ and STAT 1 expression in 3 patients. Conclusions: This study demonstrates that co-delivery of TILs and intra lesional TG1042 is feasible and safe. Stimulation of innate immunity by adenovirus expressing interferon-γ could contribute to reverse the immunotolerant profile of the tumour environment. These results support to further explore combined immunotherapies in the treatment of melanoma. Clinical trial information: NCT01082887.

scholarly journals Spanish Cell Therapy Network (TerCel): 15 years of successful collaborative translational research

Cytotherapy ◽  
2020 ◽  
Vol 22 (1) ◽  
pp. 1-5
Author(s):  
Fermín Sánchez-Guijo ◽  
Damián García-Olmo ◽  
Felipe Prósper ◽  
Salvador Martínez ◽  
Agustín Zapata ◽  
...  
Keyword(s):  
Cell Therapy ◽  
Translational Research

scholarly journals Translational Research in Osteogenesis Imperfecta and Cell Therapy

Proceedings ◽  
2021 ◽  
Vol 72 (1) ◽  
pp. 3
Author(s):  
Vrisha Madhuri ◽  
Sowmya Ramesh ◽  
Renita Raymond ◽  
Agnes Selina ◽  
Lakshmi Loganathan
Keyword(s):  
Cell Therapy ◽  
Osteogenesis Imperfecta ◽  
Translational Research ◽  
Christian Medical College ◽  
Multiple Fractures ◽  
Medical College ◽  
Regulatory Processes ◽  
The Individual ◽  
Pediatric Orthopedic ◽  
Brittle Bones

On 6 and 7 of February 2019, Center for Stem cell Research (CSCR) and Pediatric orthopedic Unit at Christian Medical College (CMC), Vellore, conducted a meet on Translational Research in Osteogenesis Imperfecta and Cell Therapy. Osteogenesis Imperfecta (OI) is a disease in which the individual has weak brittle bones which fracture easily, resulting in multiple fractures throughout their childhood. Children become deformed and often do not walk or grow normally. The meeting was conducted to highlight the newer advances and therapies for osteogenesis imperfecta and bring regulatory processes and challenges that need to be addressed.

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