New Guidelines for Stem Cell Research and Therapies Aim to Protect Patients from Charlatan Quackery
Stem cell research has never been more advanced, and as a result many different types of treatments are currently offered on the market. Unfortunate
ly, some providers are practicing quackery in stem cell therapies, and an abundance of well-intentioned scientific and medical personnel are prematurely publicizing their work. These providers and publishers have cast an unfair shadow of mistrust on this very important branch of medical research and potential treatments.
On the other hand, the contributions of professional medical and stem cell societies and other organizations require self-regulation through accreditation and certification, development of standards, and creation of a platform for collaboration among stakeholders.
Professional Guidelines for responsible Stem Cell Research
International Society for Stem Cell Research (ISSCR) is the largest professional organization of stem cell scientists. In 2007, ISSCR impaneled a broad international taskforce to develop a set of professional guidelines for responsible translational stem cell research. Their principles include high standards of preclinical evidence, peer review, scrupulous review of clinical protocol by an Institutional Review Board (IRB), rigorous informed consent, and publication of results whether positive or negative.
The general scientific consensus is that most stem cell therapies are not ready for marketing or commercialization. But the industries that are providing these treatments are increasingly sophisticated and organized, and are challenging established regulatory frameworks.
The International Society for Cellular Therapy (ISCT) has an interest in the promotion of stem cell research and development, but it also is interested in a broader range of cell-based interventions such as immune cell interventions, reproductive medicine, and gene therapy. The ISCT taskforce has working groups on definitions, scientific evidence and biological rationale, laboratory cell processing, clinical practice, regulation, commercial implications, communications, and policy.
Develop terminology, define levels of scientific evidence in new guidelines for stem cell research
The key goals are to develop an appropriate terminology, define the levels of scientific evidence needed to justify routine use or commercialization of a stem cell therapy, address questions of “experimental” and “innovative” use, and understand the global regulatory landscape in order to identify gaps and contradictions.
The ISSCR published revised guidelines for research and clinical translation involving stem cells on May 12, 2016. These new guidelines update and combine guidelines on stem cell research and clinical translation previously issued in 2006 and 2008 Jonathan Kimmelman, Associate Professor of Biomedical Ethics at McGill University, chaired the ISSCR Guidelines Update Task Force. The task force was made up of 25 experts in basic research, clinical research, and bioethics, and received feedback from 85 external individuals and organizations.
2016 guidelines: covering new ground in stem cell research
The 2016 guidelines cover new ground in areas such as gene editing and induced pluripotent stem cells. They introduce a new focus on the communication of results. The task force recognizes that results and potential applications can be exaggerated, leading to distorted understandings of research outcomes in the scientific community, popular press, and among potential patients. The “14-day rule” limiting experimentation on human embryos or embryo-like structures is upheld in these guidelines, although one task-force member has suggested that this may soon be open to revision.
In May, 2016 ISSCR released the following list of all of the new topics addressed in the revised guidelines as part of the announcement of its report:
- Define an Embryo Research Oversight (EMRO) process to encompass both human embryonic stem cell research and human embryo research that may not explicitly pertain to stem cells or generating new stem cell lines;
- Exclude the generation of induced pluripotent stem cells (iPS cells) from specific stem cell research oversight, and instead call on the existing human subjects review processes to oversee donor cell recruitment (iPS cells behave like embryonic stem cells but are derived by reprogramming more differentiated tissue cells);
- Support laboratory-based research that entails gene editing of the nuclear genomes of human sperm, egg, or embryos, when performed under rigorous review, but hold that any attempt to apply this clinically would be premature and should be prohibited at this time;
- Define principles for evaluating both basic and clinically applied research on mitochondrial replacement therapy, in concordance with recent deliberations in the U.K., U.S., and elsewhere;
- Determine that where there is no undue financial inducement to participate, it may be acceptable to compensate women who donate eggs for research;
- Recognize that the development of increasingly complex in vitro models of early stages of human development should undergo specialized review;
- Highlight opportunities to strengthen preclinical studies in stem cell research, including reproducibility and stringent standards for experimental design;
- Call for robust standards for preclinical and clinical research evidence as clinical trials progress and rigorous evaluation for safety and efficacy before marketing approval;
- Address the valuable contributions made by patients or patient groups to support clinical research and a framework to ensure this is achieved without compromising the integrity of the research;
- Highlight the responsibility of all groups communicating stem cell science and medicine—scientists, clinicians, industry, science communicators, and media—to present accurate, balanced reports of progress and setbacks.
The good news is that stem cell research is evolving into a highly respected and in-demand branch of healing that many consider to be the future of medicine. Since pluripotent stem cells have the ability to differentiate into any type of cell, they are used in the development of medical treatments for a wide range of conditions including physical trauma, degenerative conditions, and genetic diseases (in combination with gene therapy). Further treatments using stem cells are being developed due to stem cells’ ability to repair extensive tissue damage.
Great levels of success and potential have been achieved from research using adult stem cells. In early 2009, the FDA approved the first human clinical trials using embryonic stem cells. Embryonic stem cells are pluripotent, which means they can become any cell type of the body, with the exception of placental cells. More and more is being discovered about the plasticity of adult stem cells, increasing the potential number of cell types an adult stem cell can become.