Celularity and Fountain Life Launch Investigational Placental Cell Therapy Cenplacel-L in Florida Under Novel State Regulatory Framework
核心洞察
Celularity and Fountain Life announced the availability of cenplacel-L, a placental-derived allogeneic investigational cell therapy, for physician-directed use in Florida under newly enacted state legislation.
Florida Statutes § 458.3245 and § 459.0127, effective July 1, 2025, create one of the first state-level frameworks enabling allogeneic cellular therapies outside traditional FDA approval pathways.
Cenplacel-L has demonstrated immunomodulatory and regenerative potential in clinical studies and targets unmet needs in wound care, orthopedics, and other therapeutic areas permitted under state law.
Celularity Inc. (搜索) and Fountain Life Management, LLC (搜索) announced on June 4, 2026, the availability of cenplacel-L — a placental-derived allogeneic investigational cell therapy — for investigational use by licensed physicians in the State of Florida. The launch operates under recently enacted state legislation that establishes one of the first state-level frameworks in the United States enabling physician-directed use of allogeneic cellular therapies outside of traditional federal approval pathways.
Cenplacel-L, also known as PDA-001 or PDA-002 in clinical research settings, is a proprietary formulation developed by Celularity in the United States. It belongs to the broader category of stem-cell medicine and has demonstrated immunomodulatory and regenerative potential in clinical studies. The therapy represents a lead asset within Celularity's platform of off-the-shelf, allogeneic cellular therapies targeting inflammation, degeneration, and age-related disease (搜索).
Florida's Novel Regulatory Pathway
Effective July 1, 2025, Florida Statutes § 458.3245 and § 459.0127 authorize licensed physicians to perform certain cell therapies that have not yet received approval from the United States Food and Drug Administration, provided such therapies fall within the scope of the physician's practice and comply with strict sourcing, manufacturing, accreditation, and patient consent requirements. This regulatory clarity enables qualified physicians to incorporate investigational regenerative therapies into patient care while maintaining structured safeguards.
"This milestone marks the establishment of one of the first state-level frameworks in the United States enabling the physician-directed use of allogeneic cellular therapies outside of traditional federal approval pathways, creating a potential model for broader market expansion," the companies stated in their joint announcement.
Manufacturing and Clinical Infrastructure
Celularity is positioned to support this initiative through its FDA-registered, GMP-compliant manufacturing infrastructure and existing inventory of clinical-grade product, enabling near-term clinical deployment. The company maintains a robust inventory of cenplacel-L at its manufacturing facility and is prepared to support physician-directed investigational use consistent with Florida law requirements.
Robert J. Hariri, MD, PhD, Chairman and Chief Executive Officer of Celularity, emphasized the significance of the regulatory evolution: "Regenerative medicine is transitioning from theoretical promise to clinical reality, driven by advances in cell biology, manufacturing, and regulatory evolution. The human placenta is one of nature's most powerful sources of cells capable of orchestrating repair and restoring balance in the body."
Hariri added that the initiative aims to "advance access to innovations that may address unmet needs in wound care, orthopedics and other therapeutic areas permitted under state law while maintaining the highest ethical and quality standards."
Fountain Life Partnership and Clinical Integration
Celularity's collaboration with Fountain Life provides an initial clinical channel for implementation, integrating advanced diagnostics, patient selection, and physician oversight within a preventive and longevity-focused care model. Fountain Life, founded in 2020, delivers a next-generation preventive health model combining AI-guided diagnostics, restorative therapeutics, and its proprietary AI intelligence engine, Zori AI.
William Kapp, MD, Co-Founder and Chief Executive Officer of Fountain Life, stated: "Fountain Life is committed to expanding physician-led access to scientifically grounded, regenerative solutions that align with both innovation and patient safety. Aligning with Celularity's expertise in placental stem cell biology, this availability in Florida represents an important step toward responsibly broadening investigational use under an established legal and compliant framework."
The partnership is expected to support early clinical experience, inform future development strategies, and contribute to the establishment of best practices for responsible deployment of placental-derived cell therapies.
Regulatory Status and Forward Outlook
Cenplacel-L has not been approved by the FDA for any indication or use, and its availability under Florida law does not constitute FDA approval or a determination of safety or effectiveness by the FDA. The companies noted that Florida's framework may serve as a model for broader adoption, potentially creating a scalable pathway for advancement of placental-derived cell therapies in other jurisdictions.
Physicians interested in learning more about cenplacel-L and its investigational availability in Florida are encouraged to contact Celularity's medical affairs team or Fountain Life directly.