We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us

Download Mobile App





First Stem Cell Clinical Trial for Protection Against COVID-19 Approved by FDA

By HospiMedica International staff writers
Posted on 09 Apr 2020
Print article
Illustration
Illustration
The FDA has approved a Phase II clinical trial evaluating efficacy and safety of Hope Biosciences’ (Sugar Land, TX, USA) autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) to provide immune support against COVID-19. MSCs are well-known for their immunomodulatory and regenerative potential. In a recent Phase I/II clinical trial for rheumatoid arthritis, results appeared to show that HB-adMSCs were safe and effective in attenuating systemic inflammation. In COVID-19 patients, inflammation is a driving force behind disease progression, and it is critical to regulate the immune system as early as possible.

This Phase II study is a single arm, non-randomized study that is expected to enroll 75 participants that are either 50 years of age, have preexisting health conditions, or are at high-exposure risk. The study’s primary objective is to determine the efficacy of HB-adMSCs to prepare the immune system so that it is better able to fight the virus, should one become infected. Hope anticipates that this pretreatment will limit the progression and severity of COVID-19, ultimately keeping patients out of the hospital and off of mechanical ventilation. HB-adMSCs are administered via five intravenous infusions over a fourteen-week period and follow-up evaluations through six months. All participants will be monitored for changes in health status, including immune cell levels, inflammatory markers, and requirements for supplemental care or hospitalization.

This is the first of three New Drug Applications (INDs), related to COVID-19, that Hope has filed with FDA. This initial protocol is specifically designed for patients who already have their own stem cells banked with the company. The next two protocols will utilize a donor cell source that will aim in protecting against COVID-19 for those at high risk (patients and frontline workers) and treating hospitalized patients.

“This study will utilize our proprietary core technology to deliver high quality, pure mesenchymal stem cells with standardized doses and multiple treatments. Our novel technology allows us to overcome the burdens of traditional cell therapy, such as inability to make enough cells to make a significant impact. We can produce, on-demand, over 1,000 highly concentrated HB-adMSC treatments from a single tablespoon of the patient’s own fat tissue. Most people who have been severely affected by COVID-19 had preexisting conditions. We are pretreating participants who are at higher risk of developing severe COVID-19, with the belief that we can prepare their immune systems, giving them their best chance to fight the virus” said Donna Chang, President and CEO of Hope Biosciences.

“Our ultimate goal is to prevent anyone from needing mechanical ventilation. We believe that interceding early in the inflammatory process will give us the best possible outcome. Treating the disease is very important but if we have a chance to prevent the condition, we must explore all options. We appreciate the FDA’s willingness to take this groundbreaking approach at such a critical time for our nation” added Chang.

Related Links:
Hope Biosciences

Gold Member
POC Blood Gas Analyzer
Stat Profile Prime Plus
Gold Member
Disposable Protective Suit For Medical Use
Disposable Protective Suit For Medical Use
Silver Member
Compact 14-Day Uninterrupted Holter ECG
NR-314P
New
Examination Table
Powerline Backrest Top

Print article

Channels

Critical Care

view channel
Image: The permeable wearable electronics developed for long-term biosignal monitoring (Photo courtesy of CityUHK)

Super Permeable Wearable Electronics Enable Long-Term Biosignal Monitoring

Wearable electronics have become integral to enhancing health and fitness by offering continuous tracking of physiological signals over extended periods. This monitoring is crucial for understanding an... Read more

Surgical Techniques

view channel
Image: NTT and Olympus have begun the world\'s first joint demonstration experiment of a cloud endoscopy system (Photo courtesy of Olympus)

Cloud Endoscopy System Enables Real-Time Image Processing on the Cloud

Endoscopes, which are flexible tubes inserted into the body's natural openings for internal examination and biopsy collection, are becoming increasingly vital in medical diagnostics. Their minimal invasiveness... Read more

Patient Care

view channel
Image: The newly-launched solution can transform operating room scheduling and boost utilization rates (Photo courtesy of Fujitsu)

Surgical Capacity Optimization Solution Helps Hospitals Boost OR Utilization

An innovative solution has the capability to transform surgical capacity utilization by targeting the root cause of surgical block time inefficiencies. Fujitsu Limited’s (Tokyo, Japan) Surgical Capacity... Read more

Health IT

view channel
Image: First ever institution-specific model provides significant performance advantage over current population-derived models (Photo courtesy of Mount Sinai)

Machine Learning Model Improves Mortality Risk Prediction for Cardiac Surgery Patients

Machine learning algorithms have been deployed to create predictive models in various medical fields, with some demonstrating improved outcomes compared to their standard-of-care counterparts.... Read more

Point of Care

view channel
Image: The PATHFAST hs-cTnI-II high-sensitivity troponin assay has been developed for the PATHFAST Biomarker Analyzer (Photo courtesy of Polymedco)

POC Myocardial Infarction Test Delivers Results in 17 Minutes

Chest pain is the second leading cause of emergency department (ED) visits by adults in the United States, generating over 7 million visits annually. In the event of a suspected heart attack, physicians... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.