Page 39 - Mesenchymal Stem cells, Exosomes and vitamins in the fight aginst COVID

Al-Khawaga and Abdelalim Stem Cell Research & Therapy (2020) 11:437 Page 20 of 33

Table 4 The investigated outcomes of the ongoing clinical trials using MSCs and MSC-derived exosomes to treat COVID-19 patients
(Continued)
Clinical trial Primary Outcome Measure Secondary Outcome Measure
identifier
after infusion [time frame, baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10
post-infusion, 6 months, 1, 2, 3, 4, and 5 years post-infusion].
5. Changes in plasma concentration of prothrombin complex
(PK) [time frame, baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10
post-infusion, 6 months, 1, 2, 3, 4, and 5 years post-infusion].
6. Changes in plasma concentration of Creatinine [time frame,
baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6
months, 1, 2, 3, 4, and 5 years post-infusion].
7. Changes in plasma concentration of Aspartate amino
transferase (ASAT) [time frame, Baseline (pre-infusion), day 1, 2,
3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4, and 5 years
post-infusion].
8. Changes in plasma concentration of Alanine amino
transferase (ALAT) [time frame, Baseline (pre-infusion), day 1, 2,
3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4, and 5 years
post-infusion].
9. Changes in plasma concentration of N-terminal pro-brain
natriuretic peptide (NT-proBNP) [time frame, baseline (pre-infu-
sion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4,
and 5 years post-infusion].
10. Changes in blood pressure [time frame, baseline (pre-
infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2,
3, 4, and 5 years post-infusion].
11. Changes in body temperature [time frame, baseline (pre-
infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2,
3, 4, and 5 years post-infusion].
12. Efficacy; changes in pulmonary compliance [time frame,
baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion].
13. Efficacy; changes in driving pressure (plateau pressure—
PEEP) [time frame, baseline (pre-infusion), day 1, 2, 3, 4, 7 and
10 post-infusion].
14. Efficacy; changes in oxygenation (PaO 2 /FiO 2 ) [time frame,
baseline (pre-infusion), day 1, 2, 3, 4, 7, and 10 post-infusion].
15. Efficacy; duration of ventilator support [time frame, baseline
(pre-infusion), day 1, 2, 3, 4, 7, 10 and 60 post-infusion].
16. Efficacy; pulmonary bilateral infiltrates [time frame, baseline
(pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months,
1, 2, 3, 4, and 5 years post-infusion].
17. Efficacy; sequential organ failure assessment (SOFA) score
[time frame, baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10
post-infusion, end of ICU].
18. Efficacy; hospital stay [time frame, day 60 post-infusion].
19. Lung function [time frame, day 60 post-infusion, 6 months,
1, 2, 3, 4, and 5 years post-infusion].
20. Lung fibrosis [time frame, baseline (pre-infusion), day 1, 3, 7
and 10 post-infusion, 6 months, 1, 2, 3, 4, and 5 years post-
infusion].
21. 6 min walk test [time frame, 6 months, 1, 2, 3, 4, and 5 years
post-infusion].
22. Changes in quality of life [time frame, 6 months, 1, 2, 3, 4,
and 5 years post-infusion].
23. Blood biomarkers [time frame, baseline (pre-infusion), day
1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4, and 5
years post-infusion].
24. Sensitization test [time frame, baseline (pre-infusion), day
60 post-infusion]. Sensitization tests (test for donor-specific
antibodies) against KI-MSC-PL-205 donor.
NCT04457609 Clinical improvement: presence of dyspnea, presence of Leukocyte, lymphocytes, CO 2 , HCO 3 , blood base excess level,
sputum, fever, ventilation status, blood pressure, heart rate, blood oxygen partial pressure, O 2 saturation, blood PH level,
respiratory rate, oxygen saturation [time frame, 15 days]. CRP, SGOT/SGPT (AST/ALT), ureum/creatinine, eGFR, sodium,
potassium, chloride, procalcitonin, albumin, bilirubin, D-dimer
level, fibrinogen, troponin, NT proBNP level [time frame, 15
days].
Measure leukemia inhibiting factor, IL-6, IL-10, ferritin, CXCR3,
CD4, CD8, CD56 [time frame, 7 days].