New Legislation Provides Stem Cell Treatment Options to the Terminally IllOctober 19, 2017
Under the revised FDA guidelines, the agency will no longer require physicians to seek approval from each of their facilities full special review group for biomedical research. Instead, doctors may proceed after concurrence from either the chair or a single, designated board member.
Testifying before the House Energy & Commerce health subcommittee during his first hearing as FDA commissioner, Scott Gottlieb said that the agency plans to take additional steps to ease its expanded access approval process.
Meanwhile this summer, the U.S. Senate unanimously passed Right to Try legislation designed to allow terminally ill patients easier access to experimental, alternative treatments without FDA oversight.
“Reducing restrictions and streamlining the process on how terminally ill patients can best be treated certainly are positive steps in this country’s humane treatment of its citizens,” said Rita Alexander, Chief Administrative Officer at StemGenex Medical Group in La Jolla, CA.
The Right to Try legislation, authored by Sen. Ron Johnson (R-Wisc.) is championed by the Libertarian Goldwater Institute, which has worked to pass similar legislation in 37 states. The Federal version, now headed to the House, would mean the government cannot block patients from getting access to experimental treatments such as stem cell transplant therapy. Patients first would have to try all other available treatments and be unable to participate in clinical trials.
“Patients with terminal diseases ought to have a right to access treatments that have demonstrated a level of safety and could potentially save their lives,” the bill’s author said in a statement after the vote. He added, “These are real people facing their mortality with no hope. This ‘Right to Try’ piece of legislation will give those individuals and their family hope.”
Alexander noted that over the past three years, Right to Try advocates at the state level have helped enact legislation to eliminate obstacles for terminally ill patients seeking treatments that may not be approved by the FDA. “Having this legislation move forward at the Federal level is an amazing advancement for the ‘Right to Try’ advocates who have worked collectively on behalf of individuals seeking hope for terminally ill patients looking for non-FDA approved treatments.”
She added, “At StemGenex, we are committed to helping people achieve optimum health and better quality of life through the healing benefits of their own stem cells.”
“I have personally witnessed before the start of StemGenex where patients had exhausted conventional medical treatments and wanted to try alternative therapies, but couldn’t,” Alexander said. “I was one of them, suffering from severe Rheumatoid Arthritis. I had only three options: I could seek a clinical trial, travel outside the U.S. to try alternative therapies such as adult stem cell treatment or petition the FDA for access to drugs under the agency’s ‘expanded access’ or ‘compassionate use’ programs.”
Alexander added that upon final approval of the bill, doctors and patients will be able to make their own informed decisions on alternative treatments not yet approved by the FDA.
The landmark 21st Century Cures Act signed into law last year, focusing on medical innovation and medical research, also improved the general process of helping the terminally ill get an assortment of medical treatments. The act provides the FDA with the flexibility to accelerate how it evaluates regenerative medicine treatments, such as stem cell therapies, while maintaining its high standards of safety and efficacy.
“Major change is now a reality for patients who can access stem cell therapy,” said Alexander. “Today, new treatments and advances in research are giving new hope to people affected by a wide range of autoimmune and degenerative illnesses. StemGenex Medical Group is proud to offer the highest quality of care and to potentially help those with unmet clinical needs improve their quality of life.”
To find out if you are a candidate for stem cell treatment, Call (855) 742-7836 to speak with a Patient Advocate or visit www.StemGenex.com.
ABOUT StemGenex Medical Group
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 stem cell therapy 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 (NIH) 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.