Trial reportTransplantation2019
Open Randomized Multicenter Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran in Islet Transplantation.
Trial report in Transplantation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00789308 (Open Randomized Mult-Center Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran in Islet Transplantation), which is not on this map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Open Randomized Mult-Center Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran in Islet Transplantation (CIT-01)
Who cites it
24 citing papers in PubMed.
- A phase II open label clinical study of the safety, tolerability and efficacy of ILB® for Amyotrophic Lateral Sclerosis.PloS one · 2022Trial
- Targeting CXCR1/2 Does Not Improve Insulin Secretion After Pancreatic Islet Transplantation: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial in Type 1 Diabetes.Diabetes care · 2020Trial
- Review
- Reprogramming Immunogenicity of Iron Oxide Nanoparticles through Sulfated Glycan Presentation.Small (Weinheim an der Bergstrasse, Germany) · 2026Article
- eVLP-Mediated Cas9 Delivery for Preventing IBMIR in Islet Transplantation.Small (Weinheim an der Bergstrasse, Germany) · 2026Article
- Surface-Engineering of Pancreatic Islets with Chitosan Microparticles to Inhibit IBMIR in Islet Xenotransplantation.Small (Weinheim an der Bergstrasse, Germany) · 2025Article
- Article
- Xuebijing injection mitigates instant blood-mediated inflammatory reaction and enhances intrahepatic islet transplantation via target NF-κB pathway.Frontiers in immunology · 2025Article
- Hepatocyte Growth Factor Delivery to Injured Cervical Spinal Cord Using an Engineered Biomaterial Protects Respiratory Neural Circuitry and Preserves Functional Diaphragm Innervation.Journal of neurotrauma · 2024Article
- Immunoprotection Strategies in β-Cell Replacement Therapy: A Closer Look at Porcine Islet Xenotransplantation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Review
- Chemical approaches targeting the hurdles of hepatocyte transplantation: mechanisms, applications, and advances.Frontiers in cell and developmental biology · 2024Review
- Effects of different routes of heparin on instant blood-mediated inflammatory reaction after portal vein islet transplantation.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2022Article
- Current Topics of Relevance to the Xenotransplantation of Free Pig Islets.Frontiers in immunology · 2022Review
- The Influence of Microenvironment on Survival of Intraportal Transplanted Islets.Frontiers in immunology · 2022Review
- ILBJournal of personalized medicine · 2021Article
- Antioxidant Therapy in Pancreatitis.Antioxidants (Basel, Switzerland) · 2021Review
- ILBNPJ Regenerative medicine · 2021Article
- COVID-19 and islet transplantation: Different twins.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2020Review
- Low Molecular Weight Dextran Sulfate (ILBAntioxidants (Basel, Switzerland) · 2020Article
- Pancreatic islet transplantation: toward definitive treatment for diabetes mellitus.Global health & medicine · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
Abstract
backgroundWhen transplanted human pancreatic islets are exposed to blood during intraportal infusion, an innate immune response is triggered. This instant blood-mediated inflammatory reaction (IBMIR) activates the coagulation and complement cascades and leads to the destruction of 25% of all transplanted islets within minutes, contributing to the need, in most patients, for islets from more than 1 donor. Low molecular dextran sulfate (LMW-DS) has been shown in experimental settings to inhibit IBMIR.
methodsThe Clinical Islet Transplantation consortium 01 study was a phase II, multicenter, open label, active control, randomized study. Twenty-four subjects were randomized to peritransplant intraportal and systemic treatment with either LMW-DS or heparin, targeting an activated partial thromboplastin time of 150 ± 10 seconds and 50 ± 5 seconds, respectively. C-peptide response was measured with a mixed meal tolerance test at 75 and 365 days after transplant.
resultsLow molecular dextran sulfate was safe and well tolerated with similar observed adverse events (mostly attributed to immunosuppression) as in the heparin arm. There was no difference in the primary endpoint (stimulated C-peptide 75 ± 5 days after the first transplant) between the 2 arms (1.33 ± 1.10 versus 1.56 ± 1.36 ng/mL, P = 0.66). Insulin requirement, metabolic parameters, Clarke and HYPO score, quality of life, and safety were similar between the 2 treatments groups.
conclusionsEven with low dosing, LMW-DS showed similar efficacy in preventing IBMIR to promote islet engraftment when compared to "state-of-the art" treatment with heparin. Furthermore, no substantial differences in the efficacy and safety endpoints were detected, providing important information for future studies with more optimal dosing of LMW-DS for the prevention of IBMIR in islet transplantation.
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