Compliance and Regulatory Adherence
At Americell, compliance and patient safety represent the cornerstone of our operations. We are dedicated to providing ethically sourced, high-quality stem cell products exclusively derived from umbilical cord blood. As proud sponsors of the recent landmark legislation on stem cell therapy in Florida (CS for CS for SB 1768) we rigorously adhere to every regulation outlined by this statute to ensure absolute integrity, ethical sourcing, and medical compliance.
Ethical and Regulatory Commitment
Americell is committed to the highest ethical standards, ensuring that no stem cell products involve tissues derived from aborted fetuses. Our stem cells come exclusively from ethically harvested umbilical cord blood, complying fully with the intent of Florida legislation to advance regenerative medicine responsibly and ethically.
Compliance and Quality Assurance
Our stem cells strictly comply with Florida’s recently passed Stem Cell Therapy Bill (SB 1768), which Americell proudly sponsored. The rigorous criteria we adhere to include:
FDA-Registered Facility
Our stem cells are retrieved, manufactured, and stored exclusively in facilities that are registered with and regulated by the United States Food and Drug Administration (FDA).
Accredited and Certified Facilities:
Americell’s stem cell products are produced in facilities certified or accredited by the following entities
National Marrow Donor Program (NMDP)
The NMDP operates the “Be The Match” Registry, which matches patients in need of marrow or cord blood transplants with volunteer donors. Their established standards and best practices ensure patient safety and donor protection throughout the transplant process.
World Marrow Donor Association (WMDA)
WMDA coordinates international cooperation among donor registries and cord blood banks. By setting global guidelines for donation and transplant logistics, they help maximize the chances of finding a life-saving match for patients worldwide.
Association for the Advancement of Blood & Biotherapies (AABB)
AABB creates and maintains rigorous standards and accreditation programs for blood banks, transfusion services, and cellular therapy facilities. Their guidelines ensure quality and safety in blood collection, processing, and distribution worldwide.
American Association of Tissue Banks (AATB)
AATB sets operational and ethical standards for tissue banking, conducts facility inspections, and grants accreditations. Their framework ensures that tissues used in therapeutic applications are responsibly sourced, processed, and distributed.
Quality Assurance and Viability:
All our stem cell products undergo rigorous post-thaw viability analysis to confirm the presence of viable, living cells. A detailed post-thaw viability analysis report accompanies each product lot, ensuring transparency and quality assurance for physicians and their patients.
Compliance with Good Manufacturing Practices (cGMP)
Americell ensures that all procedures involving stem cell retrieval, manufacturing, storage, and distribution strictly adhere to the current Good Manufacturing Practices (cGMP) as mandated by:
- Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)
- 21 C.F.R. Part 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products)
These standards guarantee the highest level of safety, efficacy, and traceability of our products, aligning our operational procedures with FDA regulatory expectations.
Approved Applications and Physician Requirements
Americell stem cell products are specifically approved under Florida law for use by licensed physicians practicing within their professional scope, particularly for therapies related to orthopedics, wound care, and pain management.
Physicians are required to provide clear patient notifications stating:
“THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This physician performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy.”
Furthermore, physicians must obtain a comprehensive signed consent form from patients or their legal representatives prior to therapy, detailing the unapproved FDA status, anticipated outcomes, potential risks, and available alternatives.
Our Ongoing Commitment
Americell continuously maintains the highest standards of compliance, adapting to regulatory updates and maintaining complete transparency with all accrediting and regulatory bodies. Any change in certification or accreditation status of our production facilities is promptly communicated to our physician partners within 30 days.
Our unwavering commitment to regulatory compliance underscores our dedication to ethical medical advancement, patient safety, and excellence in regenerative medicine.
Americell is proud to lead with integrity, rigorously upholding these standards to earn and maintain the trust of medical professionals and their patients across the state of Florida.