PKD Foundation’s Post

We are thrilled to share the launch of the HemON NL clinical feasibility study at Sint Maartenskliniek in Nijmegen, the Netherlands. 🎉 🇳🇱 The start of HemON NL moves us one step closer to expected initiation of a global pivotal trial, called Empower BP, which is designed to provide the evidence necessary to submit a pre-market approval (PMA) to the US Food and Drug Administration (FDA) and other global regulatory authorities. This trial builds upon the Swiss HemON clinical feasibility study addressing the critical issue of hemodynamic instability after spinal cord injury (SCI). In late 2023, a study participant at Sint Maartenskliniek was implanted with our investigational ARC-IM® system to assess the safety and effectiveness of ARC-IM Therapy to address hemodynamic instability after SCI. Dr. Erkan Kurt (photographed below, holding an investigational ARC-IM Neurostimulator), a neurosurgeon at Radboudumc University Medical Center, performed the procedure. The Principal Investigator of the HemON NL study is Dr. Ilse van Nes, a leading rehabilitation physician in the spinal cord injury department of Sint Maartenskliniek.  “Sint Maartenskliniek has long been an outstanding research partner, and we are delighted to work with them on this new and exciting study to evaluate the use of ARC-IM Therapy to stabilize disruptive and potentially life-threatening fluctuations in blood pressure after SCI,” said Dave Marver, CEO of ONWARD. “This is an important but underappreciated recovery target after SCI. We hope this research and the expected upcoming pivotal study will shine a light on the importance of hemodynamic stability in this population.” We look forward to sharing more with you as we continue to work towards developing innovative solutions to address critical unmet needs in the SCI community. *All ONWARD devices and therapies, including but not limited to ARC-IM, ARC-EX®, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use. #EmpoweringMovement #SCI #clinicaltrials

Our on-demand online seminar on "MASH Pharmacotherapy" by Profil's Lead Scientist Dr. Hans de Vries is now available! Dive into the latest advances in treating Metabolic-Associated Steatohepatitis - perfect for professionals looking to stay ahead in clinical research.

I am very pleased that we can contribute to this study! In individuals with a high spinal cord injury, orthostatic hypotension is one of the consequences that can significantly impact various aspects of daily life. This treatment could make a significant contribution in reducing the consequences of this complication and improve Quality of Life. Please feel free to contact me if you are interested in this study, or if you know somebody with a spinal cord injury who might be interested! #research #spinalcordinjury #spinalcordstimulation #orthostatichypotension

Thrilled to Announce My New Review Paper! 🎉 I’m excited to share the publication of my latest review, titled: "A Missing Puzzle in Preclinical Studies—Are CCR2, CCR5, and Their Ligands’ Roles Similar in Obesity-Induced Hypersensitivity and Diabetic Neuropathy?—Evidence from Rodent Models and Clinical Studies." This paper explores the roles of CCR2, CCR5, and their ligands in the context of diabetic neuropathy, diabetes, and obesity. We summarize current findings from both rodent models and clinical studies and ask an important question: Could the same chemokines and receptors also be significant in obesity-induced hypersensitivity? Key insights from the review: • Detailed analysis of CCR2, CCR5, and their ligands levels changes in diabetes, obesity and diabetic neuropathy models. • A new hypothesis on their potential role in obesity-related pain. • The need to consider alternative pain treatments for these conditions. If you're interested in chronic pain in obesity and diabetes, this paper provides a fresh perspective and opens up important question for future research. Feel free to read the full review here: https://lnkd.in/d8ir2QuE

ONE WEEK AWAY! The 9th Microbiome Movement Drug Development Summit is in Boston, July 10 - 12. This is always a great conference. On Wednesday July 10, at 11:30am, I will be presenting the "Role of the Immune T Regulatory Cells in Mood Disorders and Alzheimer’s Disease Phenotype as a Therapeutic Target in Altered Gut-Brain Axis Cross-Talking". I will discuss the role of the gut-brain axis in the onset and progression of degenerative conditions, including #AlzheimersDisease. In particular, the implication of the causative role of T-regulatory cells mediated influence on adaptive immunity in the gut-brain axis communication. Also, strategies to intervene in the brain degenerative progression by targeting selected T-regulatory mediated mechanisms to mitigate abnormal brain permeability and disease progression in response to stress-induced mood / psychological impairment associated with the onset of #Alzheimers disease phenotype. Finally, there will be a discussion of novel strategies to move from pre-clinical observations to the clinical setting. I hope to see you there. Learn More about The 9th Microbiome Movement Drug Development Summit https://lnkd.in/evHg92Ei Icahn School of Medicine at Mount Sinai The Mount Sinai Hospital Graduate School of Biomedical Sciences at the Icahn School of Medicine Microbiome Movement

I am excited to announce the release of the latest scientific paper I had the privilege to contribute to, in collaboration with esteemed researchers from the University of East Anglia Medical School, under the guidance of Prof. Vass Vassiliou. 📄 Title: "Cost effectiveness analysis of drug coated balloon only angioplasty for de novo coronary artery disease" 🔗 Explore the full publication here: https://lnkd.in/eU45iQVs #uea #healtheconomics #cardiovasculardisease

So another publication that leaves you as a patient between a rock and a hard place: here Pharma- payments to guideline writers. Apart from being a delightful opportunity to pick apart the inconsistencies in the current debate- so surely, our guidelines are based on evidence. And surely one characteristic of evidence is that it's well, evident. Unless of course it isn't quite that evident in which case there is room for interpretation in which case that entire evidence-based guideline construct starts looking rather like a consensus exercise where suddenly personal opinions, experience and expertise count. We also know that cancer patients treated in centres with clinical trials do better than those treated in cancers without clinical trials. Which happens where the folks sit that get Pharma-funded. We obviously like to believe that academic studies aren't pharma- sponsored, aka not commercially biased (I shall not comment here whether academic bias is better or worse for patients). But if you go looking where the drugs come from- it's not that investigators sell cakes to buy those expensive therapies for their trials. The only ones that then don't get Pharma-funded are those without trials. And probably have a state system that pays for their CME trainings, too. As this evidence-thing clearly isn't quite that straightforward and interpretation therefore counts, the choice is between someone who may be influenced by having received pharma money but who has seen the drug and whose patients are likely to have better outcomes versus someone who hasn't received pharma money but who hasn't seen the drug and whose patients are likely to do worse. https://lnkd.in/d4jbgpDv

Since 2001, Richmond Pharmacology has proudly welcomed thousands of participants who come to take part in clinical trials. These dedicated individuals contribute significantly to the progress of medical science. With their help and Richmond's dedication to providing hope for patients, fast, Richmond has: - Conducted over 500 early-phase studies - Helped deliver to market more than 30 new medicines for conditions including heart failure, hypertension, and cancer. The Power of Patient Participation: In this video, we highlight the inspiring story of Rizwana, a participant in our pioneering trial for Glanzmann Thrombasthenia (GT), a rare and severe bleeding disorder. Rizwana became the first person in the world to receive a new, potential treatment. Richmond Pharmacology is committed to accelerating medical advancements. Explore Rizwana's story and learn how you can contribute to the development of life-changing treatments. Join us in shaping the future of medicine 🧬 Read more here: https://lnkd.in/efwN5m-W Haemnet  Kate Khair  ACRP - Association of Clinical Research Professionals #clinicalresearch #medicalinnovation #patientcentric #advancinghealthcare

🌟 Exciting News on a new MOOC (Massive Open Online Course) titled “Innovative Therapies and Personalized Medicine for Rare Diseases” co-developed by the Foundation For Rare Diseases (FFRD) has co-developed with the European Reference Network Transplant Child and CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche/Clinical Validation from Biopharmaceutical Findings) 🌟 This course has been developed in the context of the European Joint Programme for Rare Diseases EJPRD, a programme funded under the European Union’s Horizon 2020 research and innovation programme, aiming to create an effective rare diseases research ecosystem for progress, innovation and for the benefit of everyone with a rare disease.   The MOOC will start on Monday July 8th, and enrollments is now open at: https://lnkd.in/dsmY_-Pj This course is designed for anyone interested in knowing how recent advances in the medical research field can impact the treatment of rare disorders. The MOOC will be particularly beneficial for medical students, researchers, patient advocacy groups, healthcare professionals, and biotech developers. However, anyone with a curiosity about science, medicine, and rare conditions is encouraged to participate.

1. AdAlta has established a clinical advisory board (CAB) to support the development of its drug candidate AD-214 for treating Idiopathic Pulmonary Fibrosis (IPF). 2. The CAB is composed of renowned experts in pulmonary medicine and fibrosis, enhancing the company's strategic capabilities. 3. AdAlta has appointed a specialist adviser for translational science to further advance AD-214. 4. The upcoming Phase 2 clinical trials will build on positive results from Phase 1 studies, pending financing arrangements. 5. AD-214 aims to improve outcomes for over 500,000 patients with IPF, a currently incurable disease. 6. Key CAB members include distinguished professionals from top institutions with extensive experience in IPF clinical trials. 7. Professor Gisli Jenkins has been appointed as a translational science adviser, bridging laboratory research and clinical application. 8. The formation of the CAB signifies a significant advancement in AdAlta's commitment to progressing AD-214 through its development stages.