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.
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.
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
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
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