Sept 8, 2025, Bethesda, MD – The Association for the Advancement of Blood & Biotherapies (AABB) is pleased to announce the release of the first edition of Cell and Gene Therapy Standards for Pharmacy, which take effect Oct. 1, 2025, and are now available for purchase on the AABB Store. These new Standards represent a critical advancement in strengthening quality and safety for cell and gene therapy (CGT) products managed by pharmacies. [Read more…]
What is Regenerative Medicine?
What is regenerative medicine? Put simply, regenerative medicine is the process of replacing or repairing human genes, cells, tissues or organs in order to restore healthy function. It is the processing of working with the human body to assist it to heal itself. In that sense, it is about working “with” biology, instead of “against” or “separate from” it. [Read more…]
European Commission Grants First Approval for Expanded Cord Blood Stem Cell Therapy (Zemcelpro®)
September 10, 2025 — In a landmark move for regenerative medicine, the European Commission has conditionally authorized Zemcelpro®, the first treatment in Europe to use expanded umbilical cord blood stem cells. Developed by Canadian biotech company ExCellThera, this therapy is only the second of its kind approved worldwide and represents a major advance in transplant options for patients with blood cancers such as leukemias and myelodysplastic syndromes. [Read more…]
Congress Moves to Reauthorize Funding for National Cord Blood and Bone Marrow Transplant Programs
Legislation would authorize $280 million over 5 years to support National Cord Blood and Bone Marrow Transplant Programs.
A bipartisan group of lawmakers in the U.S. House has introduced new legislation to extend funding for two cornerstone programs that connect patients with life-saving stem cell treatments. The Stem Cell Therapeutic and Research Reauthorization Act of 2025 proposes more than $280 million in federal funding over the next five years, ensuring that these initiatives continue past their current 2026 expiration date. [Read more…]
EU Grants Approval to Zemcelpro, a Cord Blood–Derived Stem Cell Therapy for Blood Cancer Patients
In August 2025, the European Commission (EC) granted conditional marketing authorization (CMA) to Cordex Biologics, a subsidiary of ExCellThera, for Zemcelpro® (UM171 Cell Therapy), a personalized stem cell therapy derived from a single cord blood unit for blood cancer patients who lack access to a suitable donor for a traditional transplant. ExCellThera announced the news on August 27, 2025.
Zemcelpro is the first and only allogeneic cell therapy approved in the EU for this patient population. By leveraging ExCellThera’s proprietary UM171 expansion platform, the therapy enhances the viability and functionality of cord blood stem cells, overcoming a decades-long limitation: insufficient cell volume for adult transplantation. As such, Zemcelpro represents a major clinical milestone and a therapeutic breakthrough with the potential to expand the use of cord blood–derived cellular therapies in the EU and beyond. [Read more…]
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