Drug Database
BL

blood substitute (Volplex / Volplex)

✓ Approved

Sinclair · Cell-based Therapies · Cell-based Therapies

What is blood substitute?

blood substitute is a cell-based therapies developed by Sinclair. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesVolplex, Volplex
CompanySinclair
Drug ClassCell-based Therapies
RouteInjectable (Others), Intravenous (IV)
StatusApproved

Therapeutic Indications

blood substitute is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Surgical and medical proceduresAdjuvant therapy✓ Approved

Related Research Articles

PubMedMaternal & child nutrition2026-10-15

Stop Auditing Mothers and Start Auditing Systems.

Louie Jimmy Chun Yu JCY

National breastfeeding statistics are conventionally read as a measure of maternal behaviour, and the dominant policy response has been to educate and encourage individual women. This Perspective argues that breastfeeding statistics should be interpreted primarily as indicators of system performance rather than maternal behaviour. In high-income countries, much early cessation occurs among women who intended to continue breastfeeding but could not obtain timely, effective support. The resulting shortfall therefore reflects constrained choice as much as personal preference. That both the systems framing and the intention-to-cessation indicator already exist in the literature is acknowledged directly: surveillance research has measured the gap, described its risk factors, and mapped its social patterning. Viewed through a quality-and-safety lens, unwanted early cessation has many of the characteristics of a preventable harm. It is common, patterned by identifiable failures of care, and partly avertable with known interventions such as evidence-based maternity practices, proactive post-discharge contact, adequate paid leave, and protection from substitute marketing. The contribution of this Perspective is not a new metric, but a new use for an existing one. I argue that unwanted early cessation should be treated as an accountable quality indicator within the quality-and-safety systems already used for other preventable harms. Rather than remaining a descriptive statistic, it should become a measure for which health services, employers, and policymakers share accountability. The paper also addresses how intention should be measured, considers the risks of increased surveillance, safeguards maternal autonomy, avoids shifting blame onto clinicians, and distinguishes challenges in high-income settings from priorities in lower-income contexts.

PubMedFrontiers in cardiovascular medicine2026-10-15

4D-Micro: a tiered, testable framework for hemodynamic-tissue perfusion mismatch in cardiac surgery.

La Budanbaila B, Bai Yanyan Y, Du Yiri Y, Qiu Yi Y et al.

Organ dysfunction can develop after cardiac surgery even when mean arterial pressure, cardiac output, hemoglobin, temperature, and pump flow meet conventional targets. These variables remain the safety foundation, but they do not directly establish exchange-capable capillary flow or cellular oxygen use. We propose 4D-Micro, an unvalidated conceptual framework organized around four necessary functions: barrier and conduit integrity, perfusion driving, hemorheology, and cellular oxygen use. The framework was formalized from a recurrent clinical reasoning problem through targeted evidence mapping and explicit construction rules; it was not derived from a new patient dataset or statistical latent-variable analysis. 4D-Micro separates where recovery is discordant from the provisional mechanism that might explain it, then uses a prespecified proximal response and stopping boundary to update that explanation. It is not a substitute for established cardiac surgical monitoring or a claim that all four domains can be measured directly at the bedside. A tiered implementation distinguishes a core mode based on routine variables, an enhanced mode using regional and congestion signals, and a research mode using direct microvascular or biomarker measurements. Insufficient or conflicting data remain indeterminate rather than being forced into a phenotype. We specify a staged validation pathway: content and feasibility testing, prospective assessment of classification reliability and construct validity, and only then a pragmatic comparison with protocolized usual hemodynamic care. The framework should be narrowed or rejected if it cannot be applied reliably, its predicted responses are not observed, or it fails to improve decision processes without added harm.

PubMedFrontiers in cellular and infection microbiology2026-10-15

Association between blood culture positivity and in-hospital mortality in pediatric oncology patients with sepsis in the PICU: a retrospective cohort analysis.

Xing Dianwei D, Xiao Zijing Z, Liu Baiming B, Xu Jingjing J et al.

Sepsis is one of the major causes of death in pediatric oncology patients. However, whether blood culture positivity is independently associated with mortality in this high-risk, immunocompromised population remains unclear. We evaluated whether blood culture results are associated with survival outcomes in pediatric oncology patients with sepsis treated in the pediatric intensive care unit (PICU). We retrospectively identified sepsis episodes among pediatric oncology patients admitted to the PICU between 2016 and 2024 according to the Phoenix Sepsis Criteria. Clinical variables were compared by blood culture status and in-hospital survival. We used generalized estimating equation (GEE) logistic regression models that accounted for clustering of sepsis episodes within patients to assess the association between blood culture positivity and in-hospital mortality. The primary analysis included 234 sepsis episodes contributed by 209 patients; all episodes met the Phoenix pediatric sepsis criteria. Blood cultures were positive in 48 episodes (20.5%), and in-hospital death occurred in 45 episodes (19.2%). The blood culture-positive group had higher procalcitonin (PCT) levels (p = 0.015), whereas no statistically significant differences were observed in Phoenix Sepsis Score, organ function indicators, invasive mechanical ventilation (IMV) or continuous renal replacement therapy (CRRT) requirements, PICU length of stay, or in-hospital mortality. In GEE models accounting for within-patient clustering, blood culture positivity was not independently associated with in-hospital mortality (OR = 1.412, 95% CI 0.536-3.719, p = 0.485). In contrast, higher lactate and vasoactive-inotropic score (VIS) were independently associated with increased mortality, whereas higher PaO2/FiO2 and platelet counts were associated with lower mortality. In this single-center retrospective cohort of sepsis episodes among pediatric oncology patients, blood culture positivity was not independently associated with in-hospital mortality after adjustment for age, organ dysfunction markers, and prior antimicrobial exposure. In contrast, several markers of organ dysfunction remained independently associated with mortality. However, given the limited number of deaths and the potential for culture-status misclassification related to prior antimicrobial exposure, a clinically meaningful association between blood culture positivity and mortality cannot be excluded.

PubMedJournal of clinical apheresis2026-10-15

Apheresis in Children of Weight Under 7 kg-A Single Center Experience.

Rungsiprakarn Phassawan P, Wilson Bryan E BE, Rintoul Natalie E NE, Wild K Taylor KT et al.

Although apheresis techniques in children are well established, published experience with very low-weight children is limited. We reviewed 68 procedures performed in 19 children weighing less than 7 kg, including hematopoietic progenitor and T-cell collections and plasmapheresis. With significant modifications of standard techniques, all but one procedure was successfully and safely completed without serious citrate toxicity. Access was a major challenge. For plasmapheresis, the mean plasma volume removed was 1.2 × total plasma volume, but the mean total blood processed was 1.74 × total blood volume (TBV). For collections, the mean number of whole blood volumes processed was 4.1 × TBV. For T cell collections, the median CD3+ yield was 243.6 × 106/kg. For HPC collections, the median CD34+ cell yield was 14.8 × 106/kg. Mean durations for collections and plasmapheresis were 247.00 and 120.67 min, respectively. Of the CBC parameters, only platelet count was significantly lower after collections.

PubMedFrontiers in immunology2026-10-15

Integrated single-cell multi-omics analysis delineates neonatal immune dysregulation associated with gestational diabetes mellitus.

He Renke R, Liu Zhipeng Z, Meng Qingju Q, Wu Kaiyue K et al.

Gestational diabetes mellitus (GDM) is a common pregnancy complication which could induce immune dysfunction. Although intrauterine hyperglycemia impairs fetal immune development, its cell-type specific effects on neonatal immune cells, and cell‑cell communication remain unclear. In this pilot study, we performed integrated 5' single‑cell RNA sequencing and TCR repertoire analysis of cord blood mononuclear cells from two GDM and one type 2 diabetes mellitus (T2DM) mother-neonate pairs, with public healthy cord blood data (GSE157007) as controls. After quality control, 50,656 cells were analyzed using Seurat, scRepertoire, SCENIC, Monocle 2, decoupleR, and CellChat. Myeloid lineage expansion and reduced naive T‑cell proportions have been found in hyperglycemia‑exposed cord blood. TCR analysis revealed mild clonal diversity compression, a shift toward shorter CDR3 lengths, and fewer ultralong CDR3 sequences in hyperglycemia‑exposed cord blood. The Tpex‑like cell population, which co‑expresses stemness markers (TCF7, BACH2), early development markers of T cells (IKZF1, IKZF2) and the pre‑exhaustion transcription factor TOX, was enriched in cord blood from GDM and T2DM neonates. This subset displayed elevated activity of TGF-β, MAPK and PI3K signaling pathways and predominantly resided within unexpanded T cell clonotypes. Pseudotime trajectory profiling indicates that Tpex-like cells reside at an intermediate differentiation state between precursor and effector T‑cell populations. Cell communication analysis indicated increased immune interaction strength in GDM cord blood, with enrichment of pro‑inflammatory pathways (SEMA4, IL‑16, SIRP), whereas homeostatic pathways (LAIR1, GALECTIN) dominated in healthy controls. We characterized multi-layered neonatal immune dysregulation observed in the setting of GDM‑associated intrauterine hyperglycemia. Tpex‑like cells represent a candidate cellular state linked to early immune changes in GDM offspring. We firstly identified candidate molecular signatures for subsequent mechanistic and translational exploration. These pilot findings require validation in larger independent cohorts.

PubMedPakistan journal of biological sciences : PJBS2026-10-15

Procalcitonin and Interleukin-18 in Umbilical Cord Blood as Early Diagnostic Biomarkers for Early-Onset Neonatal Sepsis: A Case-Control Study.

Gusmaiyanto Devi D, Efrida Efrida E, Hardisman Hardisman H, Mayetti Mayetti M

<b>Background and Objective:</b> Early-onset neonatal sepsis (EONS) is a major cause of neonatal morbidity and mortality globally, yet its early diagnosis remains challenging due to the limited availability of rapid, reliable biomarkers at the time of birth. This study aimed to analyze procalcitonin (PCT) and Interleukin-18 (IL-18) levels measured from umbilical cord blood as early diagnostic biomarkers for EONS. <b>Materials and Methods:</b> An observational case-control study was conducted on 66 neonates born with at least one EONS risk factor at four hospitals in Riau Province, Indonesia. Subjects were classified into an EONS group (n = 33) and a non-EONS group (n = 33). Umbilical cord blood PCT and IL-18 were measured using an enzyme-linked immunosorbent assay. Normality was assessed using the Shapiro-Wilk test. Between-group differences were analyzed using the Mann-Whitney U test (α = 0.05). <b>Results:</b> The PCT levels in umbilical cord blood were significantly higher in the EONS group compared to the non-EONS group [median 322.77 (range: 66.70-2599.57) pg/mL vs. 45.9 (4.90-321.97) pg/mL; p<0.001]. The IL-18 levels were similarly elevated [median 564.00 (216.40-1979.00) pg/mL vs. 107.60 (-19.60-773.38) pg/mL; p<0.001]. Maternal fever history was significantly more frequent in the EONS group (36.4% vs. 6.1%; p = 0.005), as was colored amniotic fluid (93.9% vs. 45.5%; p<0.001). <b>Conclusion:</b> Umbilical cord blood PCT and IL-18 levels are significantly elevated in neonates with EONS and may serve as early diagnostic biomarkers for EONS when measured at the time of birth. Their combined use may improve early risk stratification and clinical decision-making in at-risk neonates.

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