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
Sources: ClinicalTrials.gov, Sinclair

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

PubMedInternational journal of spine surgery2026-07-25

Assessment of Bone Bridging of a Novel Wet-Field Regenerative Bone Adhesive for Lumbar Spine Fusion in an Ovine Model at 12, 26, and 52 Weeks.

Foley Kevin T KT, Woodard Eric J EJ, Slotkin Jonathan R JR, Gadomski Ben B et al.

Current techniques for instrumented posterolateral lumbar fusion include the use of titanium rods and pedicle screws to provide mechanical fixation, while autograft and/or allograft bone is used to promote osseous union across the fusion site. Although bone graft substitutes may be used for this purpose, they can resorb before a solid fusion is established, leading to nonunion. Tetracalcium phosphate-phosphoserine (TTCP-PS) is a novel, bioresorbable, osteoconductive, wet-field mineral-organic bone adhesive and bone graft substitute that has been previously shown to promote bone healing in a number of applications, including cranial bone flap fixation. The goal of this study was to investigate the use of TTCP-PS for fusion in a posterolateral lumbar ovine model and to compare it to a commercially available bone graft substitute. An ovine lumbar fusion model was used to evaluate the safety and efficacy of TTCP-PS mineral-organic bone adhesive compared with a currently marketed bone graft substitute as a control (Actifuse ABX) over 1 year. These substances were implanted bilaterally in 20 sheep between the L3-L4 and L4-L5 transverse processes, stabilized with a pedicle screw fixation system. Postoperative x-ray images, computed tomography scans, and histological findings were assessed at 12, 26, and 52 weeks after implantation to evaluate lumbar fusion across groups and time points. After euthanasia at 12 weeks, no statistically significant differences in the bone deposition region of interest at any of the substance implantation sites were observed. At 26 weeks, histologic analysis demonstrated new bone formation percentage to be significantly greater (P = 0.001) in the TTCP-PS sites (57%) than in the control group sites (31%). By 52 weeks, no statistically significant difference was found between groups, although the mean percentage bone growth area remained higher for the bone adhesive (52%) compared with the control (45%). TTCP-PS was safe and effective in an ovine posterolateral lumbar fusion model. TTCP-PS promoted earlier and greater (26 weeks) bone bridging in this study than a currently marketed bone graft substitute (Actifuse ABX) while producing greater levels of bone formation at 1 year after surgery. This accelerated healing may aid implant stabilization and reduce the risk of nonunion in posterolateral lumbar fusions in humans. TTCP-PS was demonstrated to be safe and effective as a bone graft substitute in this large animal posterolateral spinal fusion model. Its use resulted in superior new bone volume, greater mineral density of the fusion mass, and more rapid bone ingrowth than the control. These properties of TTCP-PS bone adhesive may improve the reliability and success of spinal fusion procedures.

PMID 42498461
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PubMedPhysiological measurement2026-07-25

Noninvasive diabetes mellitus classification based on HbA1c using the mel-frequency cepstral coefficients from the photoplethysmographic signal.

Saini Surendra Kumar SK, Tiwari Sakshi S, Sharma Anil A, Joshi Amit Mahesh AM et al.

Diabetes mellitus (DM) is a metabolic condition with improper regulation of blood sugar levels and is one of the leading global causes of death. Glycated hemoglobin (HbA1c) serves as a crucial indicator for managing diabetes. This study proposes a noninvasive approach to classify glycemic status based on HbA1c levels. This work uses novel Mel-frequency cepstral coefficient features of finger photoplethysmographic (PPG) signals and physiological parameters, enabling straightforward detection of DM. A finger PPG dataset (in reflective mode) comprising 180 subjects with diabetes, prediabetes, and normal HbA1c levels is curated and used to validate the proposed method. The dataset comprises 93 normal (HbA1c < 5.7%), 57 prediabetic (HbA1c 5.7% - 6.4%), and 30 diabetic (HbA1c ≥ 6.5%) individuals. Furthermore, a hybrid feature (HyF) selection method is employed for feature reduction. The HyF Selection-based gradient boosting model achieved effective accuracies of 93.89% for binary classification and 91.67% for multiclass classification. The results are compared with the gold standard HbA1c test. Both the binary and multiclass classifications show improved overall performance. These findings indicate that PPG signals are a feasible substitute for noninvasive HbA1c detection and have potential for wearable HbA1c monitoring.

PMID 42497900
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PubMedRSC advances2026-07-25

Smart wearable biosensors: a transformative synergy between diagnosis and treatment of disease.

Misha Yachana Y, Jena Radheshyam R, Shukla Aman A, Telange Darshan R DR et al.

Smart wearable biosensors represent a significant paradigm shift from one-time sample analysis to real-time biochemical monitoring at the body interface. Besides the flexible design of the device or wireless readout, their clinical utility will also require the reliability of the entire sensing pathway under real physiological conditions. This pathway involves biofluid access to clinical interpretation. Despite rapid progress, many wearable biosensor platforms remain limited by weak biofluid-blood correlation, receptor degradation, biofouling, motion artefacts, sensor drift and insufficient patient-level validation. Thus, a chemistry-to-clinics approach is crucial to assess the analytical reliability and translational readiness of recognition elements, sensing materials, and engineered biointerfaces. Enzymes, antibodies, aptamers, nucleic-acid systems, molecularly imprinted polymers, and nanozymes are discussed within the context of selectivity, stability, antifouling behaviour and suitability for continuous monitoring of sweat, interstitial fluid, tears, wound exudate and breath condensate. The functionality of carbon nanostructures, metal-based nanomaterials, hydrogels, MXenes, metal-organic frameworks and self-powered interfaces are evaluated in terms of their applications in amplification, mechanical conformity, biofluid handling and signal stability. Artificial intelligence is positioned as a support layer for signal correction, calibration, classification, multimodal fusion and predictive interpretation, rather than as a substitute for robust sensing chemistry. This review provides a critical chemistry-to-clinical perspective on smart wearable biosensors and outlines the validation, manufacturing, cybersecurity, post-market surveillance and benchmarking requirements needed for their translation into reliable diagnostic and therapeutic-monitoring technologies.

PMID 42500419
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PubMedThe Journal of nutrition2026-07-25

Biological mechanisms underlying the cardiovascular effects of branched-chain amino acids: A proteome-wide Mendelian Randomization Study.

Zhang Junmeng J, van Dam Rob M RM, Zhao Jie V JV

Ischemic heart disease (IHD) is the leading cause of morbidity and mortality. Branched-chain amino acids (BCAAs) are associated with higher IHD risk, but the underlying biological pathways remain unclear. This study aims to explore these pathways using two-step proteome-wide Mendelian randomization. We examined the associations between genetic proxies for BCAAs and 2,922 proteins in the UK Biobank Pharma Proteomics Project (UKB-PPP), supplemented by a meta-analysis with data from deCODE to identify proteins associated with BCAAs. Then we tested their effects on IHD risk using CARDIoGRAMplusC4D (122,733 cases, 424,528 controls) and replicated in FinnGen (31,640 cases, 187,152 controls). We conducted sensitivity analyses using genetic instruments from deCODE. Proteins associated with IHD risk and, in a consistent direction, with genetically predicted BCAAs were considered potential mediators. Genetic proxies for BCAAs were associated with 40 proteins. Among these, six proteins showed consistent evidence of mediation, including complement component 1s (C1S), coagulation factor II (F2), granulin (GRN), proprotein convertase subtilisin/kexin type 9 (PCSK9), sex hormone-binding globulin (SHBG) and V-set and transmembrane domain-containing Protein 2 Like (VSTM2L). These proteins are involved in inflammation, coagulation, lipid metabolism and cellular stress response. All associations were robust across different analytical methods and replicated in independent datasets. Mediation analysis showed that these proteins accounted for 6.5% to 32.1% of the association between BCAAs and IHD risk. This study identified six proteins that potentially link BCAAs to IHD, implicating pathways related to inflammation, coagulation, lipid metabolism, and cellular stress responses. These findings provide novel mechanistic insights into the BCAA-IHD relationship and highlight potential protein targets for future prevention and intervention strategies.

PMID 42498029
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PubMedExperimental dermatology2026-07-25

Integrated Proteogenomics and Single-Cell Transcriptomics Prioritize Putative Protective Plasma Proteins for Hidradenitis Suppurativa.

Cheng Yuzhe Y, Ma Jingyi J, Niu Jun J

Translating hidradenitis suppurativa (HS) genetic susceptibility into actionable targets remains challenging, as most genome-wide association study loci lie in non-coding regions and tissue-level transcriptomics cannot easily distinguish causal drivers from secondary inflammation. In this study, we aimed to prioritize plasma proteins whose genetically predicted levels are causally associated with HS risk and to localize them within human skin at single-cell resolution. We performed two-sample Mendelian randomization (MR) using cis-pQTL instruments for 2923 plasma proteins from the UK Biobank Pharma Proteomics Project against HS summary statistics from FinnGen R12. Following multiple-testing correction and Bayesian colocalization with a prior-sensitivity grid, the intersection of false-discovery rate (FDR)-significant MR with colocalization evidence (PP.H4 ≥ 0.5) yielded three putative protective candidates: TNFRSF6B (OR = 0.748, 95% CI 0.666-0.840; PP.H4 = 0.648), FCRL2 (OR = 0.896, 95% CI 0.819-0.979; PP.H4 = 0.550), and APOD (OR = 0.789, 95% CI 0.647-0.963; PP.H4 = 0.503). All sensitivity MR tests were concordant. Single-cell transcriptomic analysis localized FCRL2 and APOD to specific cell populations. FCRL2 was predominantly expressed in B cells and NK cells, while APOD showed multi-cellular expression across cornified keratinocytes, macrophages, and dendritic cells. Furthermore, TNFRSF6B was below the skin detection threshold, supporting its biological role as a circulating decoy receptor. Together, our integrated proteogenomic and single-cell approach prioritizes TNFRSF6B, FCRL2, and APOD as putative protective plasma proteins for HS, with TNFRSF6B emerging as the most genetically robust candidate for future translational follow-up.

PMID 42499219
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PubMedTransfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie2026-07-25

Survey on Detected "Wrong Blood in Tube" Events Based on Data from German Blood Establishments: A Feasibility Study.

Aghili Pour Hengameh H, Fiedler Sarah Anna SA, Hoch Jochen J, Humpe Andreas A et al.

"Wrong blood in tube" (WBIT) describes the discrepancy of patient identity between tube label and tube content. WBIT events can lead to an incompatible transfusion and may have serious consequences for the patient. There are currently no comprehensive evaluations or analyses of WBIT events in Germany. This study is conducted as a feasibility study. The detected WBIT (dWBIT) events from 2020 to 2023 were retrospectively recorded and analyzed. The reporting of this study is guided by the Checklist for Reporting of Survey Studies (CROSS). It is not mandatory to report WBIT events to a central supervisory authority in Germany. Therefore, a cooperation with four blood establishments (BEs) took place. The data were collected using a data collection form. The survey contains a total of 14 questions about each dWBIT event. A database was created in FileMaker 2023 for data storage and plausibility checks. In the 4 years under review, there were a total of 125 dWBIT events in the four cooperating BEs. The rate of dWBIT events results in an overall rate of one dWBIT per 4,530 blood group determinations. Frequencies varied between emergency room (1:6,897), outpatient ward (1:3,866), regular ward (1:2,564), and intensive care unit (1:863). The main reason for the error was incorrect labeling of the collection tube (19%) and blood sample taken from the wrong patient (32%). In most cases, the error was noticed in the laboratory (94%), and in 5% directly after the sample was taken. dWBIT events occurred in 87% of patients with a known blood group and in 13% of patients with a first blood group determination. The time of sampling for blood typing (time of day, day of the week, or weekend) had no influence on the dWBIT rate. None of these WBIT cases led to an ABO-incompatible transfusion. The study examines the frequency of dWBIT incidents in Germany for the first time and shows that these cases continue to represent a relevant risk, especially with regard to incompatible transfusions. Measures to minimize risk could include improving the training of transfusion staff in combination with IT-based identification and two independent blood samples for blood group typing.

PMID 42499985
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