Clinical

BioCardia Doses First Patient in CardiALLO Phase I/II Clinical Trial of BCDA-03 Allogeneic Mesenchymal Stem Cells for the Treatment of Ischemic Heart Failure of Reduced Ejection Fraction

Retrieved on: 
Tuesday, December 19, 2023

These proprietary CardiALLO human cells and their dedicated proprietary catheter delivery system are manufactured at BioCardia’s facility in Sunnyvale, California.

Key Points: 
  • These proprietary CardiALLO human cells and their dedicated proprietary catheter delivery system are manufactured at BioCardia’s facility in Sunnyvale, California.
  • We look forward to continuing this close partnership as we actively enroll additional patients in the CardiALLO MSC Study.
  • The CardiALLO MSC trial builds on the compelling early signals for benefit demonstrated in these previous trials.
  • The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC-HFT, NCT00768066),
    The Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis Pilot Study (POSEIDON, NCT01087996),
    The Transendocardial Stem Cell Injection Delivery Effects on Neomyogenesis Study (TRIDENT, NCT 02013674)

Bio-Path Holdings Successfully Completes First Dose Cohort of Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia

Retrieved on: 
Thursday, December 14, 2023

The first dose cohort consisted of a starting dose of 20 mg/m2, and there were no dose limiting toxicities.

Key Points: 
  • The first dose cohort consisted of a starting dose of 20 mg/m2, and there were no dose limiting toxicities.
  • The approved treatment cycle is two doses per week over four weeks for a total of eight doses administered over twenty-eight days.
  • The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.
  • Gail J. Roboz, M.D., is the National Principal Investigator for the Phase 1/1b trial.

SPR Therapeutics Announces Completion of Enrollment in the RESET Clinical Trial of the SPRINT® PNS System for Low Back Pain

Retrieved on: 
Tuesday, December 12, 2023

CLEVELAND, Dec. 12, 2023 (GLOBE NEWSWIRE) -- SPR Therapeutics, Inc. today announced the final patient was enrolled in the RESET Clinical Trial of SPRINT® PNS for the treatment of chronic low back pain (LBP).

Key Points: 
  • CLEVELAND, Dec. 12, 2023 (GLOBE NEWSWIRE) -- SPR Therapeutics, Inc. today announced the final patient was enrolled in the RESET Clinical Trial of SPRINT® PNS for the treatment of chronic low back pain (LBP).
  • This large multicenter randomized controlled trial (RCT) compares percutaneous peripheral nerve stimulation (PNS) with standard interventional treatments of chronic LBP.
  • The “RESET Clinical Trial: A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain” is a large RCT being conducted at more than 20 clinical centers across the United States.
  • “We are thrilled to announce the completion of enrollment in this important study, which is the largest randomized controlled trial to date studying the SPRINT PNS System.

GeneDx Presents New Data at the American Epilepsy Society Annual Meeting Demonstrating That Exome Sequencing Outperforms Multi-Gene Panels for Patients with Epilepsy

Retrieved on: 
Friday, December 1, 2023

The gap in diagnosis between exome sequencing and the multi-gene epilepsy panels can be largely attributed to the fact that more than half (57%) of seizure-related genes are not included on many commercially available epilepsy panels.

Key Points: 
  • The gap in diagnosis between exome sequencing and the multi-gene epilepsy panels can be largely attributed to the fact that more than half (57%) of seizure-related genes are not included on many commercially available epilepsy panels.
  • Of those patients with a positive genetic diagnosis from exome sequencing, 11% had a variant in a treatment related gene.
  • GeneDx will also present data at the conference that shows insurance may offer better coverage for exome sequencing than multi-gene panels for patients with epilepsy.
  • At the conference, GeneDx will also be hosting an industry sponsored symposium discussing the ways in which exome sequencing can help epilepsy patients find answers sooner.

Novotech Identifies Decentralized Clinical Trials Potential and Challenges for Accelerating Global Biotech Clinical Trials in 2024

Retrieved on: 
Sunday, November 26, 2023

Michael Stibilj, Novotech's Chief Operating Officer, will discuss the potential, challenges, and practical applications of Decentralized Clinical Trials (DCTs) from a global biotech CRO perspective.

Key Points: 
  • Michael Stibilj, Novotech's Chief Operating Officer, will discuss the potential, challenges, and practical applications of Decentralized Clinical Trials (DCTs) from a global biotech CRO perspective.
  • According to Michael Stibilj, DCTs offer an advantage in terms of potential for substantial patient recruitment and retention.
  • Currently only 5% of eligible patients are participating in clinical research.
  • According to the organizers, this year’s conference titled Clinical Research Success through Good Governance aims to facilitate communication and knowledge sharing within the global biotech research communities.

Down Syndrome Clinical Trials 2023: Comprehensive Global Analysis Report, Highlighting Regional Trends, Phases, and Sponsor Types - ResearchAndMarkets.com

Retrieved on: 
Friday, December 22, 2023

The clinical trial report, provides an overview of Down Syndrome Clinical trials scenario.

Key Points: 
  • The clinical trial report, provides an overview of Down Syndrome Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Down Syndrome.
  • The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type.
  • Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe.

IEEE EMBS Executive Committee Appoints Dr. Erika Ross Ellison as President-Elect, Along With Two New Vice Presidents

Retrieved on: 
Tuesday, December 19, 2023

Beena Ahmed and Natalie Mrachacz-Kersting were elected vice president of Conferences and vice president of Member and Student Activities, respectively.

Key Points: 
  • Beena Ahmed and Natalie Mrachacz-Kersting were elected vice president of Conferences and vice president of Member and Student Activities, respectively.
  • “My top objective will be to establish IEEE EMBS as the largest global forum for biomedical engineers, clinicians and scientists,” said Dr. Ross Ellison.
  • She is the technical representative on the IEEE EMBS administrative committee, and served as program co-chair of EMBC 2023.
  • She is an IEEE EMBS practitioner representative, and is active on the IEEE Brain steering committee.

Amedisys Finds Answer Key in Medalogix Pulse

Retrieved on: 
Thursday, December 28, 2023

NASHVILLE, Tenn., Dec. 28, 2023 /PRNewswire/ -- Medalogix, the leading data science and clinical decision support company specializing in the advancement of patient care in home health, hospice, and strategic payor initiatives in the home, and Amedisys, a leading provider of home health, hospice and high-acuity care in the home, announced an expanded partnership with the implementation of Medalogix Pulse for Home Health patients.

Key Points: 
  • Amedisys manages an ADC of over 78,000 patients in Pulse across 354 branch locations.
  • Amedisys is leveraging Pulse clinical decision support at every stage of a home health patient's journey.
  • "Pulse has been an effective approach in our strategy to manage Medicare Advantage patients," added Nick Muscato, Chief Strategy Officer, Amedisys.
  • "Medalogix is a primary enabler for how Amedisys can take risk with payers and shift to case rate structure.

EBSCO Information Services Unveils EBSCO's Clinical Decisions Dyna Innovation Center

Retrieved on: 
Wednesday, December 20, 2023

IPSWICH, Mass., Dec. 20, 2023 /PRNewswire-PRWeb/ -- A team of clinical and health care experts from EBSCO Information Services' (EBSCO) Clinical Decisions embarks on a journey to leverage generative artificial intelligence (AI) technology within its point-of-care resources, with the goal to deliver faster-than-ever access to their industry-leading, evidence-based, expert-curated, trusted information to clinicians, nurses and health care professionals.

Key Points: 
  • IPSWICH, Mass., Dec. 20, 2023 /PRNewswire-PRWeb/ -- A team of clinical and health care experts from EBSCO Information Services ' (EBSCO) Clinical Decisions embarks on a journey to leverage generative artificial intelligence (AI) technology within its point-of-care resources, with the goal to deliver faster-than-ever access to their industry-leading, evidence-based, expert-curated, trusted information to clinicians, nurses and health care professionals.
  • Clinical experts at Clinical Decisions are exploring the use of AI to bring answers directly to the bedside, making it easy to obtain near instantaneous answers, leveraging the use of large language models (LLMs) within EBSCO's trusted, evidence-based environment.
  • When considering the use of AI in a clinical environment, a judicious approach is necessary, especially considering clinical diagnosis and treatment.
  • EBSCO Vice President of Product Management, DynaMedex ™, Julia Colpitts, says the team is prioritizing a safe environment, first and foremost.

The Inner Circle Acknowledges, Haris Choudry as a Distinguished Healthcare Provider for his contributions to the fields of Physiatry and Orthopedics

Retrieved on: 
Tuesday, December 19, 2023

NEW YORK, Dec. 19, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Haris Choudry is acknowledged as a Distinguished Healthcare Provider for his contributions to the fields of Physiatry and Orthopedics.

Key Points: 
  • NEW YORK, Dec. 19, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Haris Choudry is acknowledged as a Distinguished Healthcare Provider for his contributions to the fields of Physiatry and Orthopedics.
  • Dr. Choudry pursued higher education at the University of Oklahoma where he earned a Bachelor's degree in Biochemistry.
  • He then continued at the University of Oklahoma College of Medicine where he received his medical degree and completed his residency in physical medicine & rehabilitation at SUNY Downstate Health Sciences University.
  • Physiatrists treat a wide variety of medical conditions affecting the brain, spinal cord, nerves, bones, joints, ligaments, muscles, and tendons.