مطالعات سلول درمانی از دیدگاه اخلاق در پژوهش

نوع مقاله : مقاله مروری

نویسندگان

1 کارشناس پژوهشی، مرکز تحقیقات جامعنگر عملکرد گوارش، دانشگاه علوم پزشکی اصفهان، اصفهان، ایران

2 دانشیار، گروه علوم تشریح و بیولوژی مولکولی، دانشکده‌ی پزشکی، دانشگاه علوم پزشکی اصفهان، اصفهان، ایران

3 دانشیار، گروه آندرولوژی و جنینشناسی، مرکز تحقیقات پزشکی تولید مثل، پژوهشکده‌ی زیست فناوری جانوری رویان اصفهان، اصفهان، ایران

4 استاد، بخش گوارش، گروه بیماری‌های داخلی، مرکز تحقیقات جامعنگر عملکرد گوارش، دانشگاه علوم پزشکی اصفهان، اصفهان، ایران.

چکیده

مقدمه: سلول‌های بنیادی سلول‌های تمایز نیافته‌ای هستند که می‌توانند به یک نوع یا انواع بیشتری از سلول‌های تمایز یافته و خاص تبدیل شوند. برخی از درمان‌هایی که با کمک سلول‌های بنیادی صورت می‌گیرند سال‌ها است که به عنوان روش درمانی استاندارد پذیرفته شده‌اند و امیدهایی برای گسترش این روش برای درمان سایر بیماری‌ها وجود دارد. از نگرانی‌های عمده‌ای که در ارتباط با انجام پژوهش‌های سلول درمانی وجود دارد، ایمنی استفاده از این سلول‌ها است. در این راستا سلول‌های مزانشیمال فیبروبلاست، کراتینوسیت، ملانوسیت و میوبلاست‌های اسکلتی از نظر ایمنی این سلول‌ها برای انجام مطالعات کارآزمایی بالینی، مورد بررسی قرار گرفتند.روش‌ها: ابتدا یک جستجوی نظام‌مند در پایگاه‌های الکترونیک معتبر با هدف یافتن تمامی مقالات مرتبط با ایمنی سلول‌های مورد نظر به عمل آمد. سپس نتایج حاصله به کمک روش دلفی مورد بررسی و تأیید صاحب‌نظران قرار گرفت و در نهایت، پیش‌نویس نهایی توسط اعضای کمیته‌ی اخلاق در پژوهش‌های علوم پزشکی دانشگاه، مورد بررسی قرار گرفت.یافته‌ها: 62 مقاله در مورد 4 نوع سلول مذکور مورد بررسی و مطالعه قرار گرفت.نتیجه‌گیری: با توجه به عدم گزارش عوارض جدی و به خصوص شواهدی از رشد بی‌رویه و خارج از کنترل سلول‌های فیبروبلاست، کراتینوسیت و ملانوسیت در بدن، ارائه تأییدیه‌‌ی اخلاقی به استفاده از این سلول‌ها در پژوهش‌های انسانی (صرف نظر از فرایند تهیه‌ی سلول‌ها و با رعایت کلیه‌ی جوانب و کدهای اخلاقی) امکان‌پذیر است ولی باتوجه به عوارض جدی گزارش شده از پیوند سلول‌های میوبلاست اسکلتی، ارائه‌ی تأییدیه‌ی اخلاقی به استفاده از این سلول‌ها در پژوهش‌های انسانی در شرایط حاضر نیاز به ارائه‌ی ضرورت اجرای بسیار محکم و روش اجرای بسیار دقیق (شامل معیارهای ورود به مطالعه، روش‌های پیگیری بیماران، روش‌های درمانی پروفیلاکتیک) از سوی پژوهش‌گر دارد و بررسی نهایی و صدور تأییدیه باید توسط کمیته‌ی منطقه‌ای اخلاق دانشگاه صورت گیرد و تکرار پژوهش‌های قبلی که منجر به ایجاد آریتمی و صدمه‌ی بافتی شده است توصیه نمی‌شود و غیر اخلاقی است.

کلیدواژه‌ها

عنوان مقاله [English]

Ethical Considerations in Stem Cell Therapy Studies

نویسندگان [English]

  • Fatemeh Hadizadeh 1
  • Shahnaz Razavi 2
  • Mohammad Hossein Nasr Esfahani 3
  • Payman Adibi 4
1 Research Assistant, Integrative Functional Gastroenterology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
2 Associate Professor, Department of Anatomical Sciences and Molecular Biology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
3 Associate Professor, Department of Reproduction and Development, Reproductive Biomedicine Center, Royan Institute for Animal Biotechnology, Isfahan, Iran
4 Professor, Department of Internal Diseases, Integrative Functional Gastroenterology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
چکیده [English]

Background: Stem cells are undifferentiated cells that can turn into any number of differentiated and specific cell types. For years, stem cell assisted therapy has been accepted as a standard treatment method for the management of some diseases. Scientists hope that this method can be expanded and used for the treatment of other diseases. One of the main concerns in the field of stem cell therapy research is the safety of these cells. This article assessed the safety of using mesenchymal fibroblasts, keratinocytes, melanocytes and skeletal myoblasts in clinical trials.Methods: A systematic search of reliable electronic databases was performed in order to find all articles related to safety of the mentioned cells. After studying all the articles critically, the preliminary results were reviewed and criticized by experts through Delphi method. Ultimately, the final draft was reviewed and approved by all the members of the Regional Research Ethics Committee.Findings: Overall, 62 articles were retrieved and studied. Conclusion: Since we did not find any reports of serious complications for fibroblast, keratinocyte and melanocyte cells, especially about their in-vivo uncontrolled proliferation, it is possible to give ethical approval for research in these fields (considering all ethical codes and principles). However, according to serious complications reported for skeletal myoblast cells transplantation, giving ethical approval for using this cell type in human research requires strict commitment to precise methods (such as inclusion criteria, patient follow-up methods, and prophylactic treatments). The ethical approval should be issued by the research ethics committee of the corresponding university after accurate reviews. Finally, repeating previous research which has resulted in arrhythmia and tissue injury is unethical and thus not recommended.

کلیدواژه‌ها [English]

  • Fibroblast
  • Keratinocyte
  • Melanocyte
  • Skeletal myoblast
  • Safety
  • Research ethics

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مجله دانشکده پزشکی اصفهان
دوره 29، شماره 150 - شماره پیاپی 150
مهر و آبان 1390
صفحه 1120-1136

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  • تاریخ دریافت: 28 شهریور 1390
  • تاریخ بازنگری: 01 اردیبهشت 1403
  • تاریخ پذیرش: 17 فروردین 1401

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