Trial | NCT04390152  Report issue

Title

Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19
Safety and Efficacy of Intravenous Infusion of Wharton's Jelly Derived Mesenchymal Stem Cell Plus Standard Therapy for the Treatment of Patients With Acute Respiratory Distress Syndrome Diagnosis Due to COVID 19: A Randomized Controlled Trial

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
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.
SARS-CoV-2, virus culprit of the COVID 19 that emerged in China, has become now a worldwide problem, with more than three million cases al around the world as reported by the World Health Organization. This situation has put health systems under extreme pressure, being overwhelmed be the amount of patients requiring attention.

Around 5% of patients will require ICU internation, due to severe lung inflammation giving rise to Acute Respiratory Distress Syndrome (ARDS) and a cytokine storm that ultimately affects other organs. In this group, mortality can be as high as 40%.

Mesenchymal stem cells (MSC) have shown great immunomodulatory effects, and are used in other inflammatory conditions as autoimmune diseases, being safe and preliminary effective in improving patients health status. They exert their effect via paracrine and autocrine pathways and have been shown to reduce IL-1, IL-6, Tumor necrosis factor alpha and increase IL-10 in COVID 19 patients. One of the greater advantages of the MSC is that they express no Major Histocompatibility Complex, reducing the risk of host immune reaction.

Given their immunomodulatory effects, research in this topic showing their safety and experimental efficacy are needed, as therapies for severe patients are lacking. Patients, researchers and data analysts will be blinded, and ARDS patients will be randomly allocated in standard therapy plus MSC arm or standard therapy alone to answer these questions.
Study Started
Jan 13
2020
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Apr 30
2022
Anticipated
Last Update
Jan 15
2021

Drug Wharton's jelly derived Mesenchymal stem cells.

IV Wharton's jelly derived Mesenchymal stem cells, two doses

Drug Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy) [hydroxychloroquine (plaquenil), lopinavir (Kaletra), ritonavir (Norvir), azithromycin (zithromax)]

Standard therapy as per hospital protocol, hydroxychloroquine 400mg + Lopinavir/Ritonavir 400/100 or azithromycin 500mg and Placebo

Mesenchymal stem cell Experimental

WJ MSC 50*10e6, two doses plus standard treatment with hydroxychloroquine + Lopinavir/Ritonavir or Azithromycin and ventilation support.

Control group Active Comparator

Hydroxychloroquine, lopinavir/ritonavir and ventilation support plus placebo

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.
No Results Posted