announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for its HPC, Cord Blood product REGENECYTE™, a vital cord blood stem cell therapy for transplantation in patients with blood and i...
FDA Approves Autism Stem Cell TrialThe article reports on the approval granted by the U.S. Food and Drug Administration (FDA) to clinical trials designed to determine whether stem sells from the cord blood can help in the treatmen...
"Today's approval is an important advance in cell therapy treatment in patients with blood cancers," saidPeter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "Hastening the return of the body'...
[3]. Cell models have been applied in proliferation, transplantation, and differentiation studies, and in identification of immune responses in vitro [4]. Numerous studies have shown that MSCs have great potential in immune regulation and regeneration [5]. The U.S. FDA has approved nearly 60 ...
FDA Warns About Stem Cell Claims FDA提醒有关干细胞的研究 窗体顶端 Stem cell therapies offer the potential to treat diseases or conditions for which few treatments exist.干细胞疗法提供了潜在去治疗疾病或条件的方法存在一些 Stem cells, sometimes called the body’s “master cells,” are the precursor...
The FDA will release a new policy framework this fall that will "more clearly describe the rules of the road for this new field," Gottlieb said. For example, some stem cell therapies in which cells or tissues are taken from and given back to the same individual without significant manufactur...
Stem cell clinics have received a great deal of negative press, with prominent media outlets announcing that the Food and Drug Administration (FDA) had mailed “Warning Letters” to stem cell centers across the United States. But, is this the whole story?
In September 2020, Stemedica Cell Technologies received investigational new drug (IND) approval from the US FDA for intravenous allogeneic mesenchymal stem cells (MSCs) to treat moderate to severe COVID-19. Key Market Players Want to explore hidden markets that can drive new revenue inStem Cell Th...
Radiation therapy is one of the main treatment options for many cancer patients. Although high doses of radiation may maximize tumor cell killing, dose escalation is limited by toxicity to neighboring normal tissues. This limitation applies particularly
DUCORD is approved for use in hematopoieticstem cell transplantationfor patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. The approval marks a significant achievement for Duke and the Carolinas Cord Blood Bank (CCBB), a not-...