TIANJIN, China, Jan. 26, 2026 /PRNewswire/ -- In a landmark move for the cell therapy industry, a Device Master File (DMF) describing the first dedicated quality control standard for Mesenchymal Stromal Cells (MSCs) was accepted by the U.S. Food and Drug Administration (FDA). The agency's Master File acknowledgement letter, issued on January 9, 2026, incorporates the "Tasly 3P Characterization of MSCs Assay" (MF 32345) into its regulatory framework. This step provides long-sought guidance to ensure the consistent, safe, and effective clinical use of MSCs.
Historically misclassified as stem cells, MSCs have been associated with variable clinical outcomes due to a lack of specific quality benchmarks. The newly recognized " 3P " assay directly addresses this by evaluating three core attributes: Property (cell identity), Purity (freedom from contaminants), and Potency (functional activity). This focus ensures that therapeutic MSC products are accurately defined, devoid of heterogeneous cell populations, and biologically potent. The introduction of the Tasly 3P assay marks a pivotal shift toward normalized characterization of MSCs. It mitigates historical risks such as tumor formation and therapeutic inconsistency while empowering clinicians and patients to verify cell quality before treatment. As the first FDA-recognized protocol of its kind, it establishes a new benchmark for the field and accelerates the transition in regenerative medicine from a stem-cell-centric model to a stromal cell-focused paradigm.
By endorsing a standard that aligns with the modern scientific understanding—that MSCs primarily function via paracrine signaling, not differentiation—the FDA is closing a critical regulatory gap. This alignment with updated International Society for Cell & Gene Therapy guidelines is poised to streamline Investigational New Drug applications, enhance clinical trial reliability, and foster global harmonization in MSC product evaluation.
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Landmark FDA Move: First Quality Control Protocol for Mesenchymal Stromal Cells (MSCs) Sets New Therapeutic Standard
RIYADH, Saudi Arabia, Jan. 26, 2026 /PRNewswire/ -- The Ministerial Roundtable of the third edition of the Global Labor Market Conference (GLMC) concluded today in Riyadh, chaired by His Excellency Eng. Ahmed bin Sulaiman Al Rajhi, Minister of Human Resources and Social Development, with the participation of 40 labor ministers representing G20 countries as well as Europe, Asia, the Middle East, Africa, and the Americas. The roundtable was also attended by His Excellency Mr. Gilbert F. Houngbo, Director-General of the International Labour Organization (ILO).
In his opening remarks, His Excellency emphasized the importance of constructive dialogue, noting that the Ministerial Roundtable is a cornerstone for strengthening international cooperation. He highlighted that the roundtable aims to facilitate meaningful exchange between ministers and senior officials, draw on practical labor market experiences, and identify areas of future collaboration that can deliver tangible outcomes.
Discussions focused on enabling practical knowledge-sharing among participating countries, including aligning employment policies with future workforce readiness, identifying the most effective drivers of successful employment programs, and strengthening mechanisms to ensure coherence and integration across labor market policies.
The roundtable concluded with participating ministers agreeing on six priority actions: strengthening skills recognition and portability by enabling mobility across sectors and borders. Guiding the responsible use of artificial intelligence in labor market systems through transparent governance and oversight. Adapting social protection systems to support mobility and career transitions by ensuring protections move with workers. Strengthening the use of data and analytics to actively connect individuals with opportunities and support job matching and skills development. Advancing workforce planning to anticipate disruption by preparing employment systems to respond to economic shocks and structural shifts. Improving pathways to first employment and re-entry into the labor market by enabling routes that connect individuals to meaningful opportunities for growth and progression.
Now convening for the third time in Riyadh, the Ministerial Roundtable has become a central pillar of GLMC and a leading global platform for evidence-based dialogue and international cooperation on the future of labor markets. GLMC 2026 is supported by strategic partnerships with leading international organizations, including the International Labour Organization (ILO), the World Bank, the Organisation for Economic Co-operation and Development (OECD), King's Trust International, UN Tourism, the United Nations Development Programme (UNDP), the International Organization for Migration (IOM), and the Mohammed bin Salman Foundation (Misk).
The Global Labor Market Conference is taking place on 26 and 27 January 2026 at the King Abdulaziz International Conference Center (KAICC) in Riyadh, under the theme "Future in Progress", bringing together labor ministers, heads and representatives of international organizations, private sector leaders, academic institutions, policymakers, thought leaders, and experts from around the world. The program features more than 200 speakers across over 50 sessions, with attendance exceeding 10,000 participants from within the Kingdom and internationally.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
GLMC 2026 Ministerial Roundtable Concludes with Six Priority Actions to Strengthen Global Labor Markets
