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Omidubicel, an investigational enriched umbilical cord blood product being developed by Gamida Cell for transplantation in patients with blood cancers, appears to have some advantages over standard umbilical cord blood.

The results come from a global phase 3 trial presented at the annual meeting of the European Society for Blood and Bone Marrow Transplantation.

“Transplantation with omidubicel compared to standard cord blood transplantation results in faster hematopoietic recovery, fewer infections, and fewer days in the hospital,” said coinvestigator Guillermo F. Sanz, MD, PhD, from the Hospital Universitari i Politècnic la Fe in Valencia, Spain.

“Omidubicel should be considered as the new standard of care for patients eligible for umbilical cord blood transplantation,” Sanz concluded. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia.

Source: Medscape

Roche is launching a SARS-CoV-2 variant test to help monitor emerging coronavirus mutations. The test runs on widely used high-throughput systems and is for research purposes only. The new SARS-CoV-2 Variant Set 1 Test is designed to detect and differentiate mutations found in variants that originated in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1)

Source: Reuters

Children who have been treated for brain tumors often experience significant weight gain, and new findings suggest that this could be a sign of hypothalamic-pituitary (HP) dysfunction.

The Dutch study of 661 children who survived a brain tumor found that one third become overweight, obese, or had gained a significant amount of weight during the follow-up period.

Among 578 survivors who were between 4 and 20 years of age at follow-up, 20.3% were classified as overweight and 8.5% as obese, as compared with 10.5% and 2.7%, respectively, in the general Dutch population within the same age group.

Source: The Journal of Clinical Oncology

The acronym BASILICA stands for bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction. In the procedure, performed immediately before TAVR, guidewires are introduced to the first traverse and then lacerate aortic leaflets threatening obstruction of a coronary artery.

For patients undergoing transcatheter aortic valve replacement (TAVR), the intentional laceration technique of diseased valve leaflets called BASILICA is effective and reasonably safe for preventing coronary artery obstruction, according to a late-breaking study presented at CRT 2021 sponsored by MedStar Heart & Vascular Institute.

In a series of 214 patients who entered into a registry over a recent 30-month period, leaflets posing risk were effectively traversed with the technique in 95% of cases, and complication rates were reasonably low with a 30-day stroke and death rate of 3.4%, reported Jaffar M. Khan, BMBCH, PhD, a cardiovascular branch of the National Heart, Lung, and Blood Institute.

Source: Medscape

The new 2021 Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for blood pressure management for adults with CKD who are not receiving dialysis advises treating to a target systolic blood pressure of <120 mmHg, provided measurements are “standardized” and that blood pressure is “measured properly.”

This blood pressure target — largely based on evidence from the Systolic Blood Pressure Intervention Trial (SPRINT) — represents “a major update” from the 2012 KDIGO guideline, which advised clinicians to treat to a target blood pressure of ≤130/80 mmHg for patients with albuminuria or ≤140/90 mmHg for patients without albuminuria.

Source: Medscape

IL-10 to TNFα Ratio: Strong predictor of rejection found in the blood.

A total of 244 kidney transplant recipients from the University of Pittsburgh School of Medicine participated in the study, 162 in the training set, and 82 in the internal validation set.

The investigators determined the ratio of interleukin-10 (IL-10) to tumor necrosis factor–α (TNFα) produced by transitional-1 B cells (T1B) in peripheral blood 3 months after transplant.

Their main goal was to see whether that ratio could serve as an early predictor of T-cell-mediated rejection (TCMR) in kidney transplant recipients. As the authors explain, B cells secrete IL-10 and TNFα. The ratio of these two molecules is a measure of regulatory B-cell activity, which has been implicated in organ rejection.

Source: Science Translational Medicine

KarXT – a novel combination of xanomeline with trospium.

A novel therapy that combines a muscarinic receptor agonist with an anticholinergic agent is associated with a greater reduction in psychosis symptoms compared with placebo, new research shows.

In a randomized phase 2 trial comprised of nearly 200 participants, xanomeline-trospium (KarXT) was generally well tolerated and had none of the common side effects linked to current antipsychotics, including weight gain and extrapyramidal symptoms such as dystonia, parkinsonism, and tardive dyskinesia.

The results showing robust therapeutic efficacy of a nondopamine targeting antipsychotic drug is an important milestone in the advance of the therapeutics of schizophrenia and other psychotic disorders.

Among critically ill patients with sepsis, treatment with hydrocortisone, vitamin C (ascorbic acid) and thiamine (HAT) did not improve outcome in the randomized controlled VICTAS trial.

The VICTAS trial enrolled 501 adults in the intensive-care units at 43 U.S. hospitals with sepsis-induced respiratory dysfunction, cardiovascular dysfunction, or both; 252 were randomly allocated to the combination of vitamin C (1.5 g), thiamine (100 mg), and hydrocortisone (50 mg) and 249 to placebo or placebo every six hours for 96 hours or until death or discharge from the ICU. Patients could receive open-label corticosteroids at the discretion of the clinical team; about a third of patients in each group were given corticosteroids.

The results showed no statistically significant difference in the HAT and placebo groups in the primary outcome, the number of consecutive ventilator- and vasopressor-free days in the first 30 days.

Source:

The H5N8 strain is deadly for birds, and this marks the first transmission of the strain from animals to humans and has reported the matter to the World Health Organization (WHO).

Humans and other mammals normally are not susceptible to infection by avian influenza A viruses. Nevertheless, several subtypes of avian influenza or bird-origin influenza viruses have infected humans; 3 of these subtypes have caused pandemics within the past century. At present, HPAI H5N1 is entirely an avian influenza subtype. Humans can become infected, but so far as is known, they must inhale or ingest massive viral doses from excreta or tissues of infected birds to do so.

The researchers randomized 100 healthy adult volunteers to an experimental Zika vaccine candidate known as Ad26.ZIKV.001 in either one-dose or two-dose regimens of 5×1010 viral particles (low dose) or 1×1011 viral particles (high dose) or placebo. Approximately half (55%) of the participants were women, and 72% were White.

Approximately 80% of patients in both two-dose groups showed antibody responses for a year after vaccination. Geometric mean titers (GMTs) reached a peak of 823.4 in the low-dose/low-dose group and 961.5 in the high-dose/high-dose group. On day 365, the GMTs for these groups were 68.7 and 87.0, respectively.

A single high-dose vaccine achieved a similar level of neutralizing antibody titers, but lower peak neutralizing responses than the two-dose strategies, the researchers noted.

Source: Medscape