Long-Term Safety Follow-Up Study of SCM-AGH in Subjects Who Participated and Administered SCM-AGH in to Severe Atopic Dermatitis Clinical Trials

Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued.

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Quality of randomized clinical trials published by plastic surgeons: a long-term follow-up study

Revista Brasileira de Cirurgia Plástica (RBCP) – Brazilian Journal of Plastic Sugery ◽

10.5935/2177-1235.2019rbcp0013 ◽

2019 ◽

Vol 34 (1) ◽

pp. 96-103

Author(s):

THIAGO BEZERRA MORAIS ◽

DANIELA FRANCESCATO VEIGA ◽

MIGUEL SABINO NETO ◽

LYDIA MASAKO FERREIRA

Keyword(s):

Clinical Trials ◽

Randomized Clinical Trials ◽

Follow Up Study ◽

Long Term Follow Up

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Dead Sea climatotherapy versus topical steroid treatment for atopic dermatitis children: long-term follow-up study

Journal of Dermatological Treatment ◽

10.1080/09546634.2019.1605138 ◽

2019 ◽

Vol 31 (7) ◽

pp. 711-715

Author(s):

Anna Marsakova ◽

Avraham Kudish ◽

Spyridon Gkalpakiotis ◽

Irmgard Jahn ◽

Petr Arenberger ◽

...

Keyword(s):

Atopic Dermatitis ◽

Topical Steroid ◽

Dead Sea ◽

Steroid Treatment ◽

Follow Up Study ◽

Long Term Follow Up

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Long-term follow-up and treatment outcomes of conjunctivitis during dupilumab treatment in patients with moderate-to-severe atopic dermatitis

The Journal of Allergy and Clinical Immunology In Practice ◽

10.1016/j.jaip.2020.09.042 ◽

2020 ◽

Author(s):

Roselie Achten ◽

Daphne Bakker ◽

Lieneke Ariens ◽

Amanda Lans ◽

Judith Thijs ◽

...

Keyword(s):

Atopic Dermatitis ◽

Treatment Outcomes ◽

Severe Atopic Dermatitis ◽

Long Term Follow Up

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Experience and Reason: Twenty-Year Follow-Up of Protective Immunity of the Oka Strain Live Varicella Vaccine

PEDIATRICS ◽

10.1542/peds.94.4.524 ◽

1994 ◽

Vol 94 (4) ◽

pp. 524-526

Author(s):

Yoshizo Asano ◽

Sadao Suga ◽

Tetsushi Yoshikawa ◽

Ikuko Kobayashi ◽

Takehiko Yazaki ◽

...

Keyword(s):

United States ◽

Clinical Trials ◽

Protective Immunity ◽

Protective Efficacy ◽

Varicella Vaccine ◽

The United States ◽

Follow Up Study ◽

Waning Immunity

Since the first report on the development of a live attenuated varicella vaccine in 1974, the vaccine has been studied extensively, with largely favorable results, in both healthy and leukemic children. It is now licensed in Japan, Korea, and some European countries, and is being considered for licensure in the United States. Although various clinical trials have established the safety, immunogenicity, and the efficacy of the vaccine, concern has been expressed that waning immunity in the vaccine recipients might allow the occurrence of more severe varicella later in life. We show data relevant to this concern on the approximately 20-year follow-up study of the vaccine recipients; this work further extends the experience of a long-term protective efficacy of the vaccine.

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