CompletedPhase 1/2

Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients With Respiratory Distress Due to COVID-19

Spain26 participantsStarted 2020-05-13

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Positive PCR fpr SARS-CoV-2
✓. Intensive Care Unit admission for less than 3 days
✓. Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg \< PaO2/FiO2 ≤ 200 mmHg)
✓. Male or female, aged 18 to 70 years old
✓. 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

✕. Expected survival less than 3 days
✕. Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed
✕. Neoplastic disease either active or without complete remission
✕. Immunosuppressed patients (except treatment with corticosteroids for respiratory distress)
✕. Pregnant or lactating women
✕. Participation in another clinical trial with an experimental drug in the last 30 days
✕. Other pathologies that, in medical judgment, contraindicate participation in the study

What they're measuring

All-cause mortality at day 28

Timeframe: Day 28

Trial details

NCT IDNCT04390139

SponsorBanc de Sang i Teixits

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-20

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