Ethical development of stem-cell-based interventions

MacPherson, Amanda; Kimmelman, Jonathan

doi:10.1038/s41591-019-0511-6

Cited by 31 publications

(21 citation statements)

References 152 publications

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“…Treatments should be carried out only within the scope of the emergency project managed by the Ministry of Science and Technology of the People's Republic of China, in accordance with the ' The Expert Guidance on Clinical Research and Application of Stem Cell Therapy for Novel Coronavirus Pneumonia (COVID‐19)' guidelines. Clinical research and clinical trials must be performed according to ' The Stem Cell Clinical Research Management Methods' guidelines jointly issued by the National Health Protection Commission and the National Medical Products Administration in 2015, and ' The Guidelines for Quality Control and Preclinical Study of Stem Cell Preparations (Trial)' to ensure stem cell therapies for COVID‐19 are tested in a scientifically and medically rigorous manner consistent with internationally accepted standards 89 …”

Section: Stem Cell Therapy For Covid‐19 In the Clinicmentioning

confidence: 99%

Stem cell therapy for COVID‐19, ARDS and pulmonary fibrosis

Niu

Guo

et al. 2020

Cell Proliferation

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Section: Stem Cell Therapy For Covid‐19 In the Clinicmentioning

confidence: 99%

Stem cell therapy for COVID‐19, ARDS and pulmonary fibrosis

Niu

Guo

et al. 2020

Cell Proliferation

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“…Clinical trial consents tend to focus on potential benefits rather than risks, particularly for lifethreatening diseases. 47 Even if a trial is burdensome and unlikely beneficial, some patients might prefer to receive it rather than waiting for deterioration. Therefore, when obtaining informed consent, clinicians need to be careful to avoid "therapeutic misestimation."…”

Section: Risks and Benefits For Recipientsmentioning

confidence: 99%

“…This would be one of the unique merits of hAEC transplantation in terms of the "opportunity cost," which should be discussed when designing clinical trials for cell therapy in general. 47 As the patients can continue with the basic diet therapy during this clinical trial, they would not have to forego the standard treatment while undergoing the clinical trial.…”

Section: Risks and Benefits For Recipientsmentioning

confidence: 99%

Clinical perspective on the use of human amniotic epithelial cells to treat congenital metabolic diseases with a focus on maple syrup urine disease

Takano

Grubbs

Ishige

et al. 2021

Stem Cells Translational Medicine

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Congenital metabolic diseases are a group of hereditary disorders caused by the deficiency of a single specific enzyme activity. Without appropriate therapy, affected patients suffer severe neurologic disability and eventual death. The current mainstays of management attempt to slow disease progression, but are not curative. Several of these diseases have demonstrated significant benefits from liver transplantation; however, this approach is limited by the morbidity associated with this invasive procedure and a shortage of donor organs. Therefore, there is a need to establish a new strategy for improving the quality of a life for these patients. One potential solution is regenerative therapy using hepatocytes generated from stem cells. Herein, we discuss pertinent issues necessary for clinical application of the human amniotic epithelial cell, a type of placental stem cell. Focusing on maple syrup urine disease as an example, where liver replacement is an effective therapy, we explore this approach from a clinician's perspective.

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“…Premature clinical application of stem cell based therapies and patients seeking unproven stem cell therapies outside of trials have previously been highlighted (e.g. MacPherson and Kimmelman, 2019).…”

Section: False Positives and The Emerging Literaturementioning

confidence: 99%