The International Society for Stem Cell Research (ISSCR; IL, USA) has released a professional standard of informed consent for stem cell-based interventions performed outside of clinical trials, such as unapproved and unproven ‘treatments’ offered by clinicians at direct-to-consumer clinics.
The new standard was developed by clinicians, ethicists, researchers and regulators around the world aiming to inform patients on the potential benefits and risks of stem-cell based medical interventions.
“Some of the unproven interventions are highly speculative and complex in nature. This professional standard is meant to help ensure patients have the information needed to make informed decisions about their healthcare,” commented ISSCR President Deepak Srivastava.
Roger Barker, co-chair of the ISSCR Patient Informed Consent Taskforce, added: “The ISSCR standard for informed consent is a professional guide that includes information patients should receive before choosing a potential stem cell-based treatment outside of a clinical trial.”
Most stem cell-based interventions are experimental, therefore, should only be offered within well-regulated clinical trials that have good oversight and processes in place to assess the safety and efficacy.
“Many clinicians are delivering stem cell-based interventions that are not yet proven safe or effective. This standard will help ensure that clinicians give patients information that is essential to help with their decision-making. It is part of the informed consent process that ethically and legally must precede such treatment,” commented Jeremy Sugarman, co-chair of the ISSCR Patient Informed Consent Taskforce.
Currently, there are numerous stem-cell based interventions for conditions such as Parkinson’s disease, macular degeneration and spinal cord injury going through clinical trials. As ISSCR supports the development of these interventions the guide was released to help researchers navigate the development process.
The ISSCR has advised against premature marketing and commercialization of stem cell therapies that have not been tested thoroughly through clinical trials, so this consent standard acts as an additional tool to protect patients. The newly released standard will be made widely available to physicians, healthcare advocates, medical boards, and others.