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AstroStem-V for COVID-19 Pneumonia
Study Summary
This trial is testing a stem cell treatment for safety and effectiveness in patients with COVID-19 pneumonia. After 12 weeks, data will be collected and analyzed.
- Coronavirus Pneumonia
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have a severe condition called shock that is not being controlled.You have a lung disease, but not COVID-19 pneumonia.You have a permanent brain injury or a history of cancer.The principal investigator believes you are not suitable for the study for reasons not mentioned before.You have moderate symptoms of COVID-19, such as feeling sick or having trouble breathing when you do physical activities.You have received stem cell treatment.You have severe kidney failure and need regular treatment, or you have liver cirrhosis with complications.You have a history of blood clots or high blood pressure in your lungs.Your doctor expects that you have less than 2 months to live because of your illness.You cannot take aspirin because it causes you discomfort or side effects.You have mild symptoms of COVID-19, such as normal breathing and oxygen levels, and a normal heart rate.
- Group 1: AstroStem-V
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this research open to those aged sixty-five and beyond?
"Candidates for this medical trial must meet the qualifications of being older than 19 years old, yet younger than 80."
What is the objective of this trial?
"This trial's primary outcome, to be assessed from the baseline through Week 12, is adverse events rate. Secondary outcomes encompass SpO2 measurement changes relative to baseline at each visit, Sequential Organ Failure Assessment scores (SOFA) with a 0-4 point rating for 6 physiological measurements and totalling over 3 points indicating organ failure, as well as oxygenation index changes compared to the starting values."
Is there still an opportunity to join this research endeavor?
"The trial is currently seeking participants, as attested by the clinicaltrials.gov database. This medical study was initially uploaded on October 24th 2022 and has since been amended on October 25th of the same year."
Are there certain demographics that are more advantageous for enrollment in this clinical trial?
"This study requires 10 individuals aged 19 to 80 with a recent diagnosis of pneumonia. In addition, these participants must have laboratory-confirmed SARS-CoV-2 infection and be exhibiting mild symptoms such as shortness of breath upon exertion; however, they cannot display any signs of severe COVID-19 severity. All enrollees should also demonstrate SpO2 levels ≥ 93% on room air at sea level and heart rate ≤ 90 beats per minute while adhering to the requirements set forth by their written informed consent."
How many individuals are engaged in the current research endeavor?
"Affirmative. Clinicaltrials.gov displays that this study, which was initially published on October 24th 2022 is searching for participants at present. The trail requires 10 individuals from 2 distinct sites to partake in the trial."
Is this experiment a pioneering endeavor in its field?
"Currently, 6 separate trials for AstroStem-V are in progress across 4 locations and 1 nation. The initial study for this drug was conducted by Hope Biosciences in 2020, with 24 patients participating through the Phase 1 & 2 stages of approval. Since then, a further 5 studies have been undertaken."
What other investigations have taken place related to AstroStem-V?
"AstroStem-V was first trialled in 2020 at Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU). Since then, 5 studies have concluded and 6 are currently ongoing; many of these experiments take place within Phoenix, Arizona."
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