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Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells for COVID-19
Study Summary
This trial is testing whether two different types of stem cell therapy can help treat people with moderate to severe ARDS caused by COVID-19.
- Respiratory Distress Syndrome
- COVID-19
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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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- You are currently in the hospital with a serious lung condition called moderate to severe ARDS.You are allergic or have a strong reaction to any of the ingredients used in the study.You have pneumonia caused by lung cancer or other known reasons that block your airways.You have been taking medications that weaken your immune system for a long time.You have had severe pulmonary arterial hypertension in the past.You have a long-term respiratory disease and need to use oxygen therapy.You have a severe lung condition called ARDS or acute lung injury.You are experiencing difficulty breathing, with a breathing rate of 30 breaths per minute or higher.You are currently receiving hemodialysis or peritoneal dialysis treatment.You had a blood clot in your leg or lung within the past 3 years.You are currently receiving ECMO or high-frequency oscillatory ventilation support.You are currently in the hospital with a serious lung condition called ARDS.You have a respiratory rate (RR) ≥ 30 times/min, a pulse oxygen saturation (SpO2) at rest ≤ 93% and a partial pressure of oxygen (PaO2) at rest ≤ 300mmHg.
- Group 1: Placebo
- Group 2: Experimental/treatment arm
- 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
Who is qualified to participate in this research program?
"This study requires 20 participants suffering from respiratory distress syndrome aged between 18 and 75. To be eligible, applicants must meet the following criteria: male or female, confirmed SARS-CoV-2 infection (via RT-PCR), hospitalised with moderate to severe ARDS characterised by a RR ≥ 30 times/min, SpO2 at rest ≤ 93%, PaO2/FiO02 ratio of ≤ 300mmHg; additionally, if childbearing age is applicable then effective birth control will need to be practiced until 12 weeks after treatment cessation."
Are there any vacancies available to participate in this scientific investigation?
"Affirmative. The particulars on clinicaltrials.gov show that this investigation is presently open for recruitment, with the initial post dating back to March 20th 2023 and the most recent update taking place October 11th 2022. This research requires a total of 20 participants from one trial site."
Does this trial permit the enrollment of individuals in their sixties?
"This study is looking for individuals of legal age and below 75 years to partake in the trial."
What is the scope of participation in this research?
"Affirmative. Clinicaltrials.gov reveals that this research venture, which was first published on March 20th 2021, is actively recruiting participants. Approximately twenty people need to be enrolled from one medical centre."
Are EV-Pure™ and WJ-Pure™ reliable treatments with no adverse consequences?
"Since EV-Pure™ and WJ-Pure™ are still in their first clinical trials, there is limited evidence of both efficacy and safety. Therefore, our team at Power have given it a score of 1 on the risk scale."
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