FDA grants RMAT designation to HSCT adjunct

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T cells
Image from NIAID
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ATIR101™, which is intended to be used as an adjunct to haploidentical hematopoietic stem cell transplant (HSCT). ATIR101 is a personalized T-cell immunotherapy—a donor lymphocyte preparation selectively depleted of host-alloreactive T cells through... [Read Article]
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Antibody shows early promise in AML/MDS trial

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Micrograph showing MDS
Interim results of a phase 1 study suggest flotetuzumab, a CD123 and CD3 bispecific antibody, may be a feasible treatment option for relapsed or refractory acute myeloid leukemia (AML) or intermediate/high-risk myelodysplastic syndromes (MDS). Researchers said flotetuzumab demonstrated acceptable tolerability in the dose-escalation portion of the study, with infusion-related reactions... [Read Article]
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Synthetic heparin poised for clinical trials, team says

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Lab mouse
Researchers say they have synthesized low molecular weight heparin (LMWH) that may someday replace animal-sourced heparin. The team created heparin dodecasaccharides (12-mers) using a manufacturing method that yielded gram quantities—roughly 1000-fold more than previous approaches used to synthesize LMWHs. One of these dodecasaccharides, called 12-mer-1, demonstrated safety and efficacy in animals... [Read Article]
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Paper-based diagnostic device is like ‘portable lab’

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SPED plugged into a
hand-held potentiostat
Photo courtesy of
Purdue University/Aniket Pal
Researchers say they have developed self-powered, paper-based electrochemical devices (SPEDs) that can provide sensitive diagnostics in low-resource settings and at the point of care. The SPEDs can detect biomarkers in the blood and identify conditions such as anemia by performing electrochemical... [Read Article]
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Bacterial infection inhibits hematopoiesis

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Red and white blood cells
New research suggests that bacterial infection activates hematopoietic stem cells (HSCs) and significantly reduces their ability to produce blood by forcibly inducing proliferation. These findings indicate that bacterial infections might cause dysregulated hematopoiesis like that which occurs in patients with anemias and leukemias. Hitoshi Takizawa, PhD, of Kumamoto University’s... [Read Article]
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