Ethics of research on stem cells and regenerative medicine: ethical guidelines in the Islamic Republic of Iran

Afshar, Leila; Aghayan, Hamid Reza; Sadighi, Jila; Arjmand, Babak; Hashemi, Seyed Mahmoud; Basiri, Mohsen; Samani, Reza Omani; Ashtiani, Mohammad Kazemi; Azin, Seyed-Ali; Hajizadeh‐Saffar, Ensiyeh; Gooshki, Ehsan Shamsi; Hamidieh, Amirali; Moallem, Mohammad-Reza Rezania; Azin, Seyed-Mohammad; Sadegh, Shariatinasab; Soleymani-Goloujeh, Mehdi; Baharvand, Hossein

doi:10.1186/s13287-020-01916-z

Cited by 15 publications

(14 citation statements)

References 10 publications

(13 reference statements)

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“…Human ESC research is considered an ethical problem due to the destruction of human embryos [33]. In this context, alternative stem cell sources have received a great deal of attention in order to avoid ethical quandaries for investigators [34].…”

Section: Stem Cell Technologymentioning

confidence: 99%

Current Strategies in Assessment of Nanotoxicity: Alternatives to In Vivo Animal Testing

Huang

Lee

Hsu

et al. 2021

IJMS

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Millions of experimental animals are widely used in the assessment of toxicological or biological effects of manufactured nanomaterials in medical technology. However, the animal consciousness has increased and become an issue for debate in recent years. Currently, the principle of the 3Rs (i.e., reduction, refinement, and replacement) is applied to ensure the more ethical application of humane animal research. In order to avoid unethical procedures, the strategy of alternatives to animal testing has been employed to overcome the drawbacks of animal experiments. This article provides current alternative strategies to replace or reduce the use of experimental animals in the assessment of nanotoxicity. The currently available alternative methods include in vitro and in silico approaches, which can be used as cost-effective approaches to meet the principle of the 3Rs. These methods are regarded as non-animal approaches and have been implemented in many countries for scientific purposes. The in vitro experiments related to nanotoxicity assays involve cell culture testing and tissue engineering, while the in silico methods refer to prediction using molecular docking, molecular dynamics simulations, and quantitative structure–activity relationship (QSAR) modeling. The commonly used novel cell-based methods and computational approaches have the potential to help minimize the use of experimental animals for nanomaterial toxicity assessments.

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Section: Stem Cell Technologymentioning

confidence: 99%

Current Strategies in Assessment of Nanotoxicity: Alternatives to In Vivo Animal Testing

Huang

Lee

Hsu

et al. 2021

IJMS

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“…Even if robust preclinical evidence is available using these strategies, some unexpected risk will inevitably remain, such as unforeseeable long-term adverse health events for the recipient. Researchers should be aware that preclinical evidence from animal models may not correctly predict the duration, function and interaction that occur in a human body ( 16 , 24 , 27 , 31 , 34 , 37 , 39 , 50 , 65 , 68 , 79 – 82 ). In addition, the personalization of regenerative medicine makes the product variable, therefore, the quality control and safety requirements of mass manufacturing for external validity do not apply ( 32 , 34 , 35 , 48 ).…”

Section: Resultsmentioning

confidence: 99%

Early-Phase Clinical Trials of Bio-Artificial Organ Technology: A Systematic Review of Ethical Issues

Jongh¹,

Massey²,

Cronin³

et al. 2022

Transpl Int

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Regenerative medicine has emerged as a novel alternative solution to organ failure which circumvents the issue of organ shortage. In preclinical research settings bio-artificial organs are being developed. It is anticipated that eventually it will be possible to launch first-in-human transplantation trials to test safety and efficacy in human recipients. In early-phase transplantation trials, however, research participants could be exposed to serious risks, such as toxicity, infections and tumorigenesis. So far, there is no ethical guidance for the safe and responsible design and conduct of early-phase clinical trials of bio-artificial organs. Therefore, research ethics review committees will need to look to related adjacent fields of research, including for example cell-based therapy, for guidance. In this systematic review, we examined the literature on early-phase clinical trials in these adjacent fields and undertook a thematic analysis of relevant ethical points to consider for early-phase clinical trials of transplantable bio-artificial organs. Six themes were identified: cell source, risk-benefit assessment, patient selection, trial design, informed consent, and oversight and accountability. Further empirical research is needed to provide insight in patient perspectives, as this may serve as valuable input in determining the conditions for ethically responsible and acceptable early clinical development of bio-artificial organs.

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“…Placenta samples were collected aseptically at the time of cesarean section delivery from normal full-term pregnancies. Written informed consents were obtained from all donors according to the national ethical guidelines for research on stem cells and regenerative medicine [ 18 ]. Donor’s medical records including physical examination and laboratory tests were reviewed and a blood sample was taken for complimentary laboratory tests.…”

Section: Methodsmentioning

confidence: 99%

Human placenta-derived mesenchymal stem cells transplantation in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 (phase I clinical trial): safety profile assessment

et al. 2022

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Background High morbidity and mortality rates of the COVID-19 pandemic have made it a global health priority. Acute respiratory distress syndrome (ARDS) is one of the most important causes of death in COVID-19 patients. Mesenchymal stem cells have been the subject of many clinical trials for the treatment of ARDS because of their immunomodulatory, anti-inflammatory, and regenerative potentials. The aim of this phase I clinical trial was the safety assessment of allogeneic placenta-derived mesenchymal stem cells (PL-MSCs) intravenous injection in patients with ARDS induced by COVID-19. Methods We enrolled 20 patients suffering from ARDS caused by COVID-19 who had been admitted to the intensive care unit. PL-MSCs were isolated and propagated using a xeno-free/GMP compliant protocol. Each patient in the treatment group (N = 10) received standard treatment and a single dose of 1 × 106 cells/kg PL-MSCs intravenously. The control groups (N = 10) only received the standard treatment. Clinical signs and laboratory tests were evaluated in all participants at the baseline and during 28 days follow-ups. Results No adverse events were observed in the PL-MSC group. Mean length of hospitalization, serum oxygen saturation, and other clinical and laboratory parameters were not significantly different in the two groups (p > 0.05). Conclusion Our results demonstrated that intravenous administration of PL-MSCs in patients with COVID-19 related ARDS is safe and feasible. Further studies whit higher cell doses and repeated injections are needed to evaluate the efficacy of this treatment modality. Trial registration: Iranian Registry of Clinical Trials (IRCT); IRCT20200621047859N4. Registered 1 March 2021, https://en.irct.ir/trial/52947.

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Ethics of research on stem cells and regenerative medicine: ethical guidelines in the Islamic Republic of Iran

Cited by 15 publications

References 10 publications

Current Strategies in Assessment of Nanotoxicity: Alternatives to In Vivo Animal Testing

Current Strategies in Assessment of Nanotoxicity: Alternatives to In Vivo Animal Testing

Early-Phase Clinical Trials of Bio-Artificial Organ Technology: A Systematic Review of Ethical Issues

Human placenta-derived mesenchymal stem cells transplantation in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 (phase I clinical trial): safety profile assessment

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