Celularity Applauds New Florida Law Enabling Regulated Stem Cell Therapies

Celularity Inc., a regenerative medicine company, has voiced strong support for a new Florida law effective yesterday that permits physicians to administer investigational stem cell therapies in areas such as orthopedics, pain management, and wound care. The legislation allows treatments not yet approved by the U.S. Food and Drug Administration (FDA), provided the stem cells are sourced from facilities that meet stringent quality and regulatory standards, including FDA registration, GMP compliance, and accreditation from approved bodies. Physicians are also required to obtain informed consent from patients.

"Today, a groundbreaking new law takes effect in Florida authorizing physicians to provide stem cell therapies to their patients subject to strict requirements ensuring patient safety and ethical standards. Celularity is fully prepared to supply the ethically sourced stem cells which enable these treatments, and we look forward to working with Florida physicians to make these innovative therapies available to patients," said Robert J. Hariri, M.D., Ph.D., Celularity CEO and Chairman. 

The law marks a significant milestone for companies like Celularity, which has long championed ethically sourced and advanced cellular therapies. The company traces its roots back to Anthrogenesis Corporation, which in 2001 pioneered a method for extracting a unique class of stem cells from post-partum placentas. This innovation gained national attention when President George W. Bush cited it in his landmark speech on stem cell research, recognizing its ethical and scientific significance.

"We applaud Florida's intention to advance medical treatments and improve patient outcomes with this balanced approach to fostering medical innovation while upholding ethical standards. Celularity is the long-standing leader in the field of ethically sourced stem cell therapies with extensive knowledge and real world data obtained from multiple clinical trials, including wound care and other therapeutic targets authorized under the new Florida law," said Dr. Hariri. 

Celularity currently maintains a state-of-the-art cell therapy manufacturing and storage facility, registered with the FDA and compliant with all requirements laid out in Florida’s new policy. The company has an inventory of placenta-derived stem cell units ready for use in investigational applications aligned with the law, positioning it to play a key role in advancing access to novel regenerative therapies in the state.

"We believe Florida's physician-focused approach is a model for other states, insofar as physicians are ideally positioned to assess which therapeutic approach is in a patient's best interest, including investigational stem cell therapies," said Dr. Hariri, noting the Florida Medical Association's statement that it "was extensively involved in the crafting of this legislation and sought to ensure that a proper balance was struck between protecting the public from bogus therapies and preventing physician overregulation."

"Celularity is positioned right now to supply the stem cells necessary to fulfill the objectives of the new Florida law and we look forward to working with Florida physicians to ensure their patients have access to stem cell therapies," said Dr. Hariri.