Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Recent COVID 19 pandemic has overwhelmed health services all around the world, and humanity has yet to find a cure or a vaccine for the treatment of patients, mainly the severe ones, who pose a therapeutic challenge to healthcare professionals given the paucity of information we have regarding SARS-CoV-2 pathogenesis.

Recently, reports mainly from China from patients treated with mesenchymal stem cells have shown promise in accelerating recovery, even in the critically ill and the therapy has sustained an increase in research because of it's powerful immunomodulatory effects, making it and interesting alternative in patients with lung and systemic inflammation.

These effects could help treat a lot of patients and improve their outcomes, reason why phase I/II studies are needed to show their safety and experimental efficacy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioXcellerator
• Collaborator: Clinical Somer
• Treatments: Azithromycin; Hydroxychloroquine; Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• SARS-CoV-2 positive Real Time - Polymerase Chain Reaction

• Moderate to severe Acute respiratory distress syndrome according to Murray classification.

• PaO2/FiO2 less than 200 mmHg.

• Within 36 hours of orotracheal intubation.

• Absence of response with previous standard therapy.

• Willing to participate in the study expressed by patient or responsible caregiver.

• Not being in other clinical trial.

Exclusion Criteria:

• Current pregnancy.

• Cardiac rhythm abnormalities with instability.

• Acute congestive heart failure/cardiogenic shock.

• Severe comorbidities affecting mortality as defined by research group.

• Cancer history in the past 5 years.

• HIV, syphilis, hepatitis B or C.

• Concomitant use of immunosuppressive therapy with contraindication to MSC.

• Fivefold elevation of liver enzymes (ALT, AST).

• Chronic kidney disease with glomerular filtration rate below 30ml/min or dialytic needs.