For some years now CIRM has been raising the alarm about the growing numbers of clinics offering unproven and unapproved stem cell therapies. But we are not alone. Now a leader of the California state Assembly is taking action, trying to ensure the clinics follow the law and don’t endanger patients.
Kevin Mullin is the Speaker pro Tem in the Assembly. He is championing a bill, AB 617, that will create a Stem Cell Clinic Regulation Advisory Group. In a news release Mullin said the motivation behind the bill is simple:
“As the Chair of the Select Committee on Biotechnology, I have heard from patients who have experienced both sides of the treatment continuum. It is clear that more must be done to ensure the proper regulation of for-profit stem cell clinics.”
Concerns about these clinics are well-founded. The clinics claim the treatments they offer – usually involving the use of the patient’s own fat or blood cells – can help address everything from arthritis to Alzheimer’s but offer little or no proof. Because the “therapies” are not approved by the FDA they are not covered by insurance, so people spend thousands, sometimes tens of thousands of dollars for something that is almost guaranteed to do little to help. In some cases, the “treatments” have had disastrous results, harming patients.
The news release from Speaker pro Tem Mullin’s office says CIRM has helped position California as a leader in stem cell research.
“Unfortunately, not all stem cell clinics are adhering to the expected high standards of review within the industry and, as a result, patients have been subjected to unscrupulous, sometimes harmful practices. AB 617 will address those entities by creating a Stem Cell Clinic Regulation Advisory Group.”
The Advisory Group will review existing licensing and certification laws for clinics offering stem cell therapies. The Group would then make recommendations to the Legislature about ways to improve the existing rules and ensure greater protection for patients. CIRM has been working with Speaker pro Tem Mullin on AB 617 and, as our President & CEO, Maria Millan, said we will continue to do so.
“We fully support AB 617 and Speaker pro Tem Mullin’s efforts to protect California consumers from unregulated and unproven stem cell treatments. AB 617 will help patients, their families and the medical community identify legitimate clinics that offer scientifically tested clinical trials and treatments that meet federal regulatory requirements. The field of regenerative medicine and cell and gene therapy are coming of age and entering the realm of medical practice, so AB 617 would set up an important foundation for ensuring that the highest quality care is provided to patients seeking these treatments.”