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Stem Cell Therapy
Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells for COVID-19
Phase 1
Waitlist Available
Research Sponsored by Vitti Labs, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Summary
This trial tests a new treatment using special cells and particles from umbilical cords, given through a drip. It targets hospitalized COVID-19 patients with severe lung problems. The treatment aims to reduce lung damage and improve breathing by enhancing the body's natural healing abilities.
Eligible Conditions
- Acute Respiratory Distress Syndrome
- Respiratory Distress Syndrome
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To Assess the safety of EV-Pure™ and WJ-Pure™ administration in patients exhibiting moderate to severe ARDS associated with COVID-19, compared to placebo.
To assess the efficacy of EV-Pure™ and WJ-Pure™ compared to placebo, in patients with moderate to severe ARDS assoociated with COVID-19
Secondary study objectives
COVID-19 polymerase chain reaction (PCR) test result as negative
Overall Survival
Time to clinical improvement
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental/treatment armExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
Vitti Labs, LLCLead Sponsor
2 Previous Clinical Trials
29 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Experimental/treatment arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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