Workflow
Stem Cell Standardization
icon
Search documents
Adia Med Leads Charge to Standardize Umbilical Cord Stem Cell Use Nationwide, Prepares Presentation for New Head of DHHS and FDA
Newsfileยท 2025-03-20 13:30
Core Viewpoint - Adia Med is leading an initiative to standardize umbilical cord stem cell use in the U.S., focusing on quality, safety, and accountability to enhance trust in regenerative medicine [1][2][3] Group 1: Initiative Overview - The initiative aims to establish rigorous best practices, including third-party verification and homologous applications, to redefine standards in regenerative medicine [1][3] - Adia Med plans to present these standards to the new head of the Department of Health and Human Services and the FDA to address inconsistencies in stem cell therapies [1][5] Group 2: Current Challenges - Patients have faced issues with low-quality or non-viable stem cells, leading to a lack of trust and limited potential in regenerative medicine [2][5] - Reports of patients receiving substandard stem cells are increasing, highlighting the urgent need for standardized practices [5][9] Group 3: Proposed Standards - Key pillars of the standardization framework include homologous use standards and strict quality control protocols for harvesting, processing, and storing stem cells [3][4] - Third-party verification will be required for all labs providing stem cell products, ensuring minimum stem cell count and viability for each batch [8] Group 4: Industry Impact - The initiative aims to enhance patient safety by reducing risks associated with poor-quality cells and ensuring treatment consistency across providers [9] - By establishing ethical standards, the initiative seeks to eliminate bad actors in the industry and restore trust among patients [9]