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

NCT04390152 | Terminated Phase 1 DMC

• 1 other identifier: BIOXSOMCOV001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

coronavirus; stem cell research; mesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

• Intergroup mortality difference with treatment

  Evaluation of efficacy of WJ-MSC defined by mortality at 28 days of application.

  28 days.

Secondary Outcomes (16)

• Number of patients with treatment related adverse events

  6 months.

• Difference in days of mechanical ventilation between groups

  From ICU admission to 180 days.

• Median reduction of days of hospitalization

  From hospital admission to 180 days.

• Median reduction of days of oxygen needs

  From hospital admission to 180 days.

• Difference between "Sequential Organ Failure Assessment" score between groups

  Baseline to 7 days

Other Outcomes (4)

• Changes in 6 minute walk between groups

  6 months

• Changes in Pulmonary Computed Tomography Scan between groups

  6 months

• Changes in Spirometry between groups

  6 months

Study Arms (2)

Mesenchymal stem cell

EXPERIMENTAL

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

Drug: Wharton's jelly derived Mesenchymal stem cells.

Control group

ACTIVE COMPARATOR

Hydroxychloroquine, lopinavir/ritonavir and ventilation support plus placebo

Drug: Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy)

Interventions

Wharton's jelly derived Mesenchymal stem cells. DRUG

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

Mesenchymal stem cell

Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy) DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioXcellerator: lead

Study Sites (2)

Clinical Somer

Rionegro, Antioquia, Colombia

Location

BioXcellerator

Medellín, Antioquia-CO, 050022, Colombia

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Coronavirus Infections

Interventions

Hydroxychloroquine; Lopinavir; Ritonavir; Azithromycin; Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Erythromycin; Macrolides; Polyketides; Lactones; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alfredo Hernandez-Ruiz, MSc

  Clinica Somer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient code will be stored in sealed, opaque envelops with their respective codification. These envelops will be stored in Clinica Somer's Research Unit and the only person with access permission will be the pharmaceutical chemist in charge. Treatment delivery (MSC or placebo) will also be in charge of the chemist, guaranteeing blinding of patient and healthcare professionals. Data analysis will be done by people blind to the treatment received by each patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 15, 2020
• Study Start: January 13, 2020
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)