FDA Allows Phase 2b Long COVID Study
A Phase 2b, Multi-center, Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of Intravenous Allogenic Bone Marrow-derived Mesenchymal Stem Cells in Subjects with Dyspnea Associated with Post-acute Sequelae of SARS-CoV-2 Infection.
“Long COVID is a significant health problem that has emerged in the wake of the pandemic. Because long COVID presents in a number of ways that involve symptoms like shortness of breath, brain fog and fatigue, effective therapies are hard to design. MSCs possess broad anti-inflammatory and anti-fibrotic properties that may benefit the underlying condition,” says Mark Nicolls, MD, Division Chief of Pulmonology, Allergy and Critical Care Medicine at Stanford University.
SONOMA, Calif. – Pulthera, LLC has received notice from the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) that it can proceed with “A Phase 2b, Multi-center, Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy,…
ProMedica today announced the promising results of its new study that evaluated the use of stem cells in the treatment of adult COVID-19 patients. Eight patients elected to participate in a study under Emergency Investigational New Drug…
Stemedica Cell Technologies, Inc. has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) approval for “A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and preliminary Efficacy of Intravenous Allogeneic…
Pulthera is a US-based biopharmaceutical company that specializes in revolutionary therapeutics designed to protect against the destruction of vital tissue and organs caused by infectious pathogens, including Acute Respiratory Distress Syndrome (“ARDS”) and Post-acute Sequelae of SARS-CoV-2 Infection (COVID-19).
As the exclusive licensee of these new therapies, it is our mission to leverage the proprietary technology and therapeutics to become a global leader in the infectious disease (COVID-19), pulmonary, respiratory and lung-health field.
Addressing the Pandemic
Billions have been spent on preventing the spread of COVID-19 through vaccine development. More needs to be invested addressing those who have been (and will be) infected with COVID-19, and the long-term impact to the lungs and other vital organs.
With the help of Rho, Inc., a leading global contract research organization, and protocol chief, Mark Nicolls, MD, who currently serves as Division Chief of Pulmonary, Allergy, and Critical Care Medicine at Stanford University, Pulthera will study the impact of MSCs as a therapeutic to aid those recovering from long COVID.
Beyond the Pandemic
Lung-related medical conditions impact hundreds of millions of patients globally each year, with medical costs in the multi-billions of dollars.
- COPD is the third leading cause of death in the United States with a treatment market in excess of $70 billion
- Asthma effects over 24 million in the US with a treatment market in excess of $15 billion
- Other possible indications include: Pneumonia, Pulmonary Fibrosis, Cystic Fibrosis, and more…
Pulthera therapeutic products are uniquely positioned to address many of these conditions, and we working to design clinical trials to validate the safety and efficacy of our treatments in human subjects.
Take Action Now
Pulthera is working to advance the following objectives:
- Initiate Phase 2b clinical trial using Mesenchymal Stem Cells (MSCs) to Treat Long COVID in Adult Patients that was recently allowed by the FDA (Oct-22)
- Complete the on-going Phase 2a clinical trial for ARDS in severe and critically severe COVID-19 patients
- Accelerate MSCs commercial manufacturing capabilities, and
- Advance the clinical application of at least one other lung-related medical condition
Pulthera seeks to leverage its proprietary technology and therapeutics to become a global leader in the pulmonary, respiratory and lung-health field.
Contact Us for more information:
James Snider, CEO – firstname.lastname@example.org