The ISSCR appreciates the new framework proposed by Australia’s Therapeutic Goods Administration (TGA) for the regulation of human cell and tissue products that use a person’s own cells (‘autologous use’). These new regulations are meant to halt the marketing and administration of unproven cell therapies that have not been proven safe or effective. Sales of these products by unscrupulous clinics to desperate patients have been increasing in recent years. Recently, these products resulted in the death of an Australian patient and the blinding of three patients in the United States.

On 12 March, a day before a vote in the U.S. House of Representatives on 'Right to Try' legislation, the ISSCR wrote a letter to House leadership expressing opposition to the measure, which would have allowed patients access to experimental medical treatments without FDA oversight and approval. The measure was narrowly defeated 13 March.

The ISSCR commends the U.S. Food and Drug Administration (FDA) for reaffirming its regulatory authority over stem cell biologics and clarifying the criteria that determine which cell-based products fall under its oversight. These guidance documents will provide greater transparency for patients, medical professionals, and law enforcement authorities, about the legal status of stem cell treatments in the U.S.