Official Title
A Prospective, Double-blind, Randomized, Parallel, Placebo-controlled Pilot Clinical Trial for the Evaluation of the Efficacy and Safety of Two Doses of WJ-MSC in Patients With Acute Respiratory Distress Syndrome Secondary to Infection by COVID-19
Brief Summary

Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and 28. Long term follow-up will be performed at 3, 6 and 12 months.

Detailed Description

This is a prospective, double-blind, randomized, parallel, placebo-controlled pilot clinical
trial to assess the efficacy and safety of two infusions of Wharton Jelly mesenchymal stromal
cells (WJ-MSC) in patients with moderate acute respiratory distress syndrome (ARDS) secondary
to SARS-CoV-2 infection. The study will enroll 30 patients who after signing the informed
consent will be checked for inclusion and exclusion criteria. Patients will then be
randomized (1:1) to one of the 2 treatment arms: Treatment A WJ-MSC/WJ-MSC; Treatment B
Placebo/ Placebo. The 2 infusions will be administered endovenously on day 1 (D1) and on D3.
Thereafter, patients will be followed-up on days 3, 5, 7, 14, 21, and 28 Once the study is
completed, controls will be established at 3 months, 6 months and 12 months as long-term
follow-up.

The study treatments (A or B) will be added on top of the Standard of Care treatment
prescribed by the attending physician. Each dose of MSC-WJ will consist of the intravenous
administration of 1E6cells/Kg.

Recruitment will be competitive for the centers participating in the study. A Data Safety and
Monitoring Board (DSMB) will be established to review safety and efficacy along the trial.

Completed
COVID-19
SARS-CoV 2
Adult Respiratory Distress Syndrome

Drug: XCEL-UMC-BETA

Administration on top of the standard administered treatment
Other Name: WJ-MSC

Other: Placebo

Administration on top of the standard administered treatment

Eligibility Criteria

Inclusion Criteria:

1. Positive PCR fpr SARS-CoV-2

2. Intensive Care Unit admission for less than 3 days

3. Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg <
PaO2/FiO2 ≤ 200 mmHg)

4. Male or female, aged 18 to 70 years old

5. Signed informed consent by the patient or by a legal representative (in this case, can
be obtained by phone, although it must be confirmed in writing later, accepted by
email)

Exclusion Criteria:

1. Expected survival less than 3 days

2. Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids
being allowed

3. Neoplastic disease either active or without complete remission

4. Immunosuppressed patients (except treatment with corticosteroids for respiratory
distress)

5. Pregnant or lactating women

6. Participation in another clinical trial with an experimental drug in the last 30 days

7. Other pathologies that, in medical judgment, contraindicate participation in the study

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
Spain
Locations

Hospital de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain

Mútua de Terrassa
Terrassa, Barcelona, Spain

Hospital del Mar
Barcelona, Spain

Hospital Vall d'Hebron
Barcelona, Spain

Hospital Clínic de Barcelona
Barcelona, Spain

Antoni Torres, MD, PhD, Study Chair
Hospital Clinic of Barcelona

Banc de Sang i Teixits
NCT Number
Keywords
ARDS
MeSH Terms
COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome