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Associated Press
21-05-2025
- Business
- Associated Press
How SeaStar Medical Is Leveraging Its Breakthrough Medical Device Designation To Help Critically Ill Patients
By Meg Flippin Benzinga DETROIT, MICHIGAN - May 21, 2025 ( NEWMEDIAWIRE ) - Eric Schlorff, CEO of SeaStar Medical Holding Corp. (NASDAQ: ICU), was recently a guest on Benzinga's All-Access. SeaStar Medical seeks to bring organ-saving and life-saving solutions to critically ill patients who are suffering from hyperinflammation. The company's first therapy, QUELIMMUNE, which was approved by the U.S. Food and Drug Administration last year, is designed to treat pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition. SeaStar is also engaged in a trial evaluating the safety and efficacy of its second proprietary Selective Cytopheretic Device (SCD) therapeutic in adults with AKI. That trial already has half of the adults enrolled and represents a market opportunity Schlorff says is worth about $4.5 billion a year. SeaStar, which has received several Breakthrough Device Status designations from the FDA, is betting its therapy can be broadly applied to many serious, life-threatening conditions. Watch the full interview here: Featured image byAnnie SprattonUnsplash. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. This content was originallypublished on further disclosureshere.
Medscape
21-05-2025
- Health
- Medscape
Pentoxifylline Ineffective in Alcoholic Hepatitis With AKI
Pentoxifylline, an anti–tumor necrosis factor alpha agent, did not improve survival outcomes in patients with severe alcohol-associated hepatitis complicated by acute kidney injury (AKI). METHODOLOGY: Severe alcohol-associated hepatitis is a life-threatening condition with corticosteroid treatment as the only therapy demonstrating short-term benefits, leading to the investigation of potential alternative therapies, such as pentoxifylline, particularly for patients having from AKI. Researchers conducted a retrospective cohort study to examine the effect of pentoxifylline on mortality outcomes in patients meeting the National Institute on Alcohol Abuse and Alcoholism clinical criteria for severe alcohol-associated hepatitis and AKI. The study included 525 patients (median age, 48 years; 26.1% women) from 20 centers across eight countries; participants were divided into two groups: The pentoxifylline group (n = 47) and the control group (n = 478). The primary endpoint was time to death, with liver transplantation considered a competing event. TAKEAWAY: Survival rates were comparable between the pentoxifylline and control groups at all timepoints: Day 30 (63.8% vs 63.7%), day 90 (46.2% vs 49.8%), and day 180 (39.6% vs 45.6%). Pentoxifylline use was not significantly associated with an increased risk for death ( P = .291); however, older age, higher Model for End-Stage Liver Disease scores at admission, and the use of renal replacement therapy were significantly associated with an increased risk for mortality ( P < .02 for all). = .291); however, older age, higher Model for End-Stage Liver Disease scores at admission, and the use of renal replacement therapy were significantly associated with an increased risk for mortality ( < .02 for all). An exploratory analysis focused on patients with more severe AKI (defined as having creatinine levels of ≥ 1.5 mg/dL) also showed similar results. The main causes of death in both groups were multiple organ failure, infections, esophageal variceal bleeding, and renal failure. IN PRACTICE: 'Pentoxifylline showed no significant benefit on mortality in patients with sAH [severe alcohol-associated hepatitis] and AKI,' the authors concluded, noting that 'further studies are needed to refine treatment strategies for this high-risk group.' SOURCE: This study was led by Francisco Idalsoaga, Pontificia Universidad Católica de Chile, Santiago, Chile, and was published online in eGastroenterology . LIMITATIONS: The retrospective nature of this study may have introduced selection bias. This study could not evaluate the degree of alcohol abstinence achieved following hospitalization or include information on the initiation of therapy for alcohol use disorder, both of which could have influenced long-term outcomes. The lack of data on the exact duration and timing of pentoxifylline treatment further limited the interpretation of findings. DISCLOSURES: One author reported receiving financial support from the Chilean government through the Fondo Nacional de Desarrollo Cientifico y Tecnológico. One author reported being an editorial board member of eGastroenterology .
Medscape
08-05-2025
- Health
- Medscape
Lymphoma and CAR T–Related Renal Injury: Assessing the Risks
In the treatment of non-Hodgkin lymphoma with CD19 chimeric antigen receptor (CAR) T-cell therapy, baseline kidney function did not appear to be associated with an increased risk of developing acute kidney injury (AKI) from the treatment. However, other key factors, including low albumin, showed a link. 'Our study is the largest to date examining renal toxicity in CD19 CAR T–treated lymphoma patients,' senior author Roni Shouval, MD, PhD, director of the Precision Cellular Therapy Laboratory at Memorial Sloan Kettering (MSK) Cancer Center, New York City, said in an interview. While the findings show no link between baseline kidney function and the development of AKI, ultimately, 'hypoalbuminemia may be a better flag for AKI risk and a prompt for closer monitoring or proactive interventions such as fluid management and nephrotoxin avoidance,' Shouval said. The study was published in March in Haematologica . CAR T-cell therapy is known to provide durable disease remission in relapsed or refractory non-Hodgkin lymphoma, including in the disease subsets of large B-cell lymphoma (LBCL) and mantle cell lymphoma (MCL). While the common treatment-related toxicities of cytokine release syndrome (CRS) and immune effector cell–associated neurologic syndrome (ICANS) are well documented, less has been reported regarding AKI treatment–related effects and outcomes. The US Food and Drug Administration Adverse Event Reporting System (FAERS) AKI Reports To investigate, Shouval, first author Alexander P. Boardman, MD, also of MSK, and colleagues first screened data from the FAERS database, identifying 5912 patients who had adverse events related to CD19 CAR T-cell therapy reported between January 2017 and September 2022. The patients had a median age of 62 years, and the most common CAR T-cell therapies utilized were axi-cel (n = 3526 patients), followed by tisa-cel (n = 1780), liso-cel (n = 178), and brexu-cel (n = 428). The main indications for CAR T-cell treatment were non-Hodgkin lymphoma (88%) and acute lymphoblastic leukemia (11%). Overall, 211 (3.6%) patients developed AKI that was determined to have a primary etiology of CD19 CAR T-cell therapy, with no significant differences based on age, sex, event year, type of CD19 CAR T-cell therapy, or indication. Of note, AKI was more common among patients treated with CD19 CAR T-cell therapy than among all other patients with cancer in the FAERS database (age- and sex-adjusted reporting odds ratio [ROR], 1.72). AKI developed at a median of 2.5 days post-infusion, and patients with AKI were more likely to have had concurrent CRS than those with other CAR T-cell reports not involving AKI (64% vs 50%; P < .001). The rates of life-threatening illness (22.75% vs 8.00%) and mortality (49% vs 23%; P < .001 for all) were higher among patients with AKI than among those with other CD19 CAR T-cell reports not involving AKI. 'In the FAERS dataset, we observed a disproportionately high reporting of AKI among CAR T recipients compared to other oncology patients, reinforcing that renal toxicity is a consistent safety signal on a population level,' Shouval said. A Closer Look In a subsequent single-center analysis, the authors identified 399 patients with relapsed or refractory non-Hodgkin lymphoma treated with CD19 CAR T-cell therapy at MSK Cancer Center between April 2016 and December 2023. Of the patients, 84% had LBCL, 11% had MCL, and 5% had non-LBCL. Their median age was 66 years, and the most common treatments included were axi-cel (46%), tisa-cel (20%), liso-cel (29%), and brexu-cel (5%). Of note, patients' pre-lymphodepletion estimated glomerular filtration rate (eGFR) was not associated with overall or progression-free survival, CRS grade ≥ 2, ICANS grade ≥ 2, or neutropenia. 'Thus, baseline renal function was not significantly associated with efficacy or toxicity endpoints,' the authors reported. AKI, Kidney Outcomes From the time of CAR T-cell infusion to day 100, AKI of any grade was reported among 39 (10%) of the MSK patients, with only a small percentage (5%) having grade ≥ 2 AKI. The majority of AKI cases (71.8%) were attributed to prerenal factors; 14 cases occurred concurrently with CRS. For survival outcomes, those developing AKI within 100 days of treatment had significantly lower progression-free survival (hazard ratio [HR], 2.63; P < .001) and overall survival (HR, 3.36; P < .001) than those without AKI. And among those with AKI grade ≥ 2, progression-free survival was significantly lower (HR, 3.14; P < .001), as was overall survival (HR, 4.18; P < .001). Low Albumin, Inflammatory Markers Linked to Increased AKI Risk Notably, after a multivariate adjustment, serum albumin level prior to lymphodepletion was a significant risk factor for AKI (HR, 0.15; P < .001). In addition, higher levels of inflammatory markers, specifically serum interleukin 6 (HR, 1.74; P = .008) and tumor necrosis factor alpha (HR, 2.23; P < .001), on day 0, just prior to CAR T-cell infusion, were significantly associated with the risk for AKI 'Intriguingly, we are the first to determine that hypoalbuminemia is strongly associated with risk of AKI after CAR T-cell therapy,' the authors reported. 'Hypoalbuminemia emerged as an even more robust independent predictor of AKI than baseline eGFR,' Shouval added. 'In clinical terms, we believe hypoalbuminemia is surrogate for frailty and possibly systemic inflammation,' he said. 'Therefore, patients with low albumin should be recognized as high risk for renal complications.' 'Overall, we find that most AKI events after CAR T-cell infusion are of grade 1 and that most patients recover from these events within 3 months,' the authors wrote. However, in looking at the eGFR and AKI outcomes together, Shouval concluded that 'these data position AKI as both a clinically meaningful and prognostically significant complication, deserving greater attention in the CAR T risk-benefit assessment.' Findings Point to a 'Cytokine-Driven Phenomenon' Commenting on the research, Michael D. Jain, MD, PhD, medical director of the Immune and Cellular Therapy Program at the H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, noted that the findings underscore that CAR T-cell therapy 'is really a cytokine-driven phenomenon rather than related to comorbidities that cause baseline chronic kidney disease [CKD].' He added that low albumin, often a marker of inflammation/cytokines, 'might contribute to AKI because it affects intravascular volume and thus blood flow to the kidney.' Jain agreed that the risk for AKI and other complications from CAR T is 'related more to tumor burden and inflammation than to baseline renal dysfunction.' 'In our center, we have protocols to give CAR T cells to patients who are on dialysis and believe we can safely deliver their therapy,' he noted. A Word of Caution Re CKD In a smaller study of 155 patients treated with CAR T-cell therapy for relapsed/refractory LBCL, a history of CKD was, contrarily, found to indeed be associated with AKI on a multivariate analysis (RR, 2.7; P = .04). However, while in Shouval's study, most patients who had low eGFR (< 60 mL/min/1.73 m2) received either liso-cel or tisa-cel, in this study, the majority of patients received axi-cel. Based on that, 'I would offer caution [using CAR T-cell therapy] in those with CKD, especially in those receiving axi-cel,' senior author Narendranath Epperla, MD, of the James Cancer Hospital, The Ohio State University, Columbus, Ohio, said in an interview. He added, however, that Shouval's research importantly 'highlights a clinically relevant yet understudied complication of CAR-T that would aid clinicians in decision-making and counseling peri-CAR T.'
Medscape
08-05-2025
- Health
- Medscape
Hyperlactataemia Tied to Poor Mortality in Patients With AKI
Serum lactate levels of more than 4 mmol/L on admission to the intensive care unit (ICU) were associated with an increased rate of 60-day mortality in patients with acute kidney injury (AKI) receiving renal replacement therapy (RRT). METHODOLOGY: Researchers conducted a retrospective study over a 4-year period to examine the effect of serum lactate levels during admission to the ICU on mortality in critically ill patients with AKI receiving RRT. to examine the effect of serum lactate levels during admission to the ICU on mortality in critically ill patients with AKI receiving RRT. They included 154 patients (mean age, 62.8 years; 30.5% women) with stage 3 AKI who received RRT and had data on serum lactate levels at ICU admission; most patients (81.2%) received continuous RRT, and 18.8% of patients received intermittent haemodialysis. Hyperlactataemia was defined as a serum lactate level above 4 mmol/L on admission to the ICU; 56 patients (36.4%) had acute hyperlactataemia prior to admission to the ICU. Demographic, comorbidity, and laboratory data were collected from electronic hospital databases and medical records; the severity of illness was evaluated using the Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II score, Sepsis-related Organ Failure Assessment (SOFA) score, and Charlson Comorbidity Index (CCI). TAKEAWAY: During the 60-day observation period post-ICU admission, 118 patients (76.6%) died, with most deaths (70.1%) occurred during treatment in the ICU; the mean length of ICU stay was 15.7 days. Patients who died were older ( P < .001), were more likely to have heart failure ( P = .01), and had a higher severity of illness during admission to the ICU (mean CCI, 3.7; P < .001); however, no significant differences in SOFA and APACHE II scores were observed between survivors and non-survivors. < .001), were more likely to have heart failure ( = .01), and had a higher severity of illness during admission to the ICU (mean CCI, 3.7; < .001); however, no significant differences in SOFA and APACHE II scores were observed between survivors and non-survivors. At 60 days, the survival rate was significantly lower in patients with hyperlactataemia ( P = .032). = .032). Age (hazard ratio [HR], 1.023; P = .048) and serum lactate levels (HR, 1.065; P = .033) were identified as independent predictors of mortality in this study. IN PRACTICE: "The practical recommendation is to measure serum lactate at several points during the ICU stay: on admission, before starting RRT and regularly during and after RRT," the authors wrote. SOURCE: This study was led by Robert Ekart, University Medical Centre Maribor, Maribor, Slovenia, and was published online on April 30, 2025, in BMC Nephrology . LIMITATIONS: This study was limited by its small sample size and single-centre design. Additionally, the study lacked an analysis of serial measurements of serum lactate levels before and after the start of RRT until discharge, death, or the end of the 60-day observation period. DISCLOSURES: This study did not receive any funding. The authors declared having no competing interests.
Gulf Business
26-04-2025
- Business
- Gulf Business
AKI sets the stage for continued growth, launches next-gen fulfilment centre
Image credit: Building on an entrepreneurial spirit spanning more than four decades, has inaugurated a state-of-the-art Fulfilment & Innovation Centre in Dubai Industrial City, part of TECOM Group,, that will serve as a cornerstone for the company's continued regional expansion. The 1 million sq ft facility not only quadruples AKI's fulfilment capacity but also raises the benchmark for agile, sustainable supply chain operations in the UAE. It already handles over half a million units per day, with the capacity to scale up to one and a half million units. The site also includes provisions to expand by nearly 200,000 sq ft in the near future. The centre will serve more than 30,000 business customers, as well as support home delivery services for consumers across the UAE. A privately held Emirati holding company, AKI has continuously expanded its supply chain infrastructure over more than four decades. The company's end-to-end, in-house capability enables AKI to meet ever-increasing customer expectations across multiple sectors including pharmaceuticals, medical and laboratory equipment, retail, food and non-food consumer goods, fitness, automotive, environmental services, contracting, and more. New fulfilment center located in Dubai Industrial City 'Dubai Industrial City is proud to be the home of AKI's new fulfilment centre,' says Saud Abu Alshawareb, EVP– Industrial at TECOM Group. 'Our district's proximity to Jebel Ali Port, Al Maktoum International Airport, and an Etihad Rail freight terminal enables connectivity for Al Khayyat Investments' new fulfilment centre and sets it up for long-term success. Home to more than 1,100 manufacturing champions and 350 operational factories, Dubai Industrial City is committed to supporting such strategically significant projects, in line with Operation 300bn, Make it in the Emirates, and Dubai Economic Agenda 'D33'.' Samer Sabri, group chief supply chain officer at AKI, adds: 'This facility is a testament to the extraordinary teams within AKI who embrace diverse thinking to push boundaries, do more, and set the benchmark in supply chain excellence. The facility will truly redefine AKI's position within the UAE market, ensuring swifter and more efficient distribution capabilities for our growing business ecosystem.' With connectivity to major transport and logistics networks, the facility allows for unrestricted movement of cargo to and from all major ports, Etihad Rail cargo terminal, as well as the eagerly anticipated expansions to Maktoum International Airport.
