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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Banc de Sang i Teixits

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