Landmark Bill Helps Regulation Catch Up to 21st Century Stem Cell Therapies
LA JOLLA, Calif., Dec. 19, 2016 /PRNewswire/ -- History is in the making as the 21st Century Cures Act, a landmark piece of legislation focused on medical innovation and medical research was signed into law by President Obama. This bill provides the Food and Drug Administration (FDA) flexibility to accelerate its ways of evaluating regenerative medicine treatments, such as stem cell therapies, while maintaining its high standards of safety and efficacy.
"Adult stem cells are potentially the most diverse and effective healing agents ever known," says Dr. Steven Brody, Chief Scientific Officer of StemGenex. "They have been proven to treat an astounding variety of conditions, ranging from injuries to chronic, debilitating diseases."
As a selected presenter at the September FDA Public Hearing on the future regulation of stem cell therapies, Dr. Brody highlighted the importance of a regulatory pathway to ensure patient safety while simultaneously accelerating access to stem cell treatment for patients. Additionally, nine StemGenex patients from around the country traveled to Washington, D.C. to testify as well about their real world experience with adipose stem cell therapy and the difference they said it made to their Rheumatoid Arthritis, Parkinson's Disease and Multiple Sclerosis symptoms.
"The 21st Century Cures Act speaks very loudly for patients with unmet clinical needs who have little or no other available treatment options," says Dr. Brody. "Patients' voices were heard and taken seriously."
This massive piece of legislation has very important provisions that will positively impact regenerative medicine and stem cell therapies:
- It directs the FDA to consider "real world evidence" and allows evidence of study data, rather than full clinical trial records.
- This legislation makes sure that the FDA and stakeholders work together on standards development.
- It means using sources like patient registries, electronic health records and other data collected outside the formal clinical trial process will most likely be considered in the risk-benefit assessment.
"This important piece of legislation will potentially unleash many more treatment options, including stem cell treatment, to those suffering with incurable diseases," says Rita Alexander, Chief Administrative Officer of StemGenex Medical Group. "This bill is a victory for the average person fighting a disease."
About StemGenex
StemGenex Medical Group is committed to helping people achieve optimum health and better quality of life through the healing benefits of their own stem cells. StemGenex provides access to stem cell therapy options for individuals suffering with inflammatory and degenerative illnesses. Committed to the science and innovation of stem cell treatment, StemGenex sponsors five clinical outcome studies registered with the National Institutes of Health for Multiple Sclerosis, Parkinson's Disease, Rheumatoid Arthritis, Chronic Obstructive Pulmonary Disease (COPD) and Osteoarthritis. These have been established to formally document and evaluate the quality of life changes in individuals following adipose-derived stem cell treatment.
For more information, visit www.stemgenex.com, or contact Jamie Schubert, Director of Media and Community Relations, [email protected], 800-609-7795.
SOURCE StemGenex
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