Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "With both subject and the evaluating physician blinded; subjects will be administered the investigational drug injection and placebo (saline) injection at Visit 1 (Day 0); by a non-evaluating (unblinded) study site staff member and will be followed up and re-evaluated by a blinded evaluating physician at Visit 2 (Day 1); Visit 3 (Day 7); Visit 4 (Day 14); Visit 5 (Day 21); Visit 6 (Day 30); Visit 7 (Day 60); Visit 8 (Day 90); visit 9 (day 120); and visit 10 (day 180). At each visit; participants (and accompanying caregivers) will be informed/reminded about study design; responsibilities; and possible adverse events. Intervention: Intravenous infusion of purified exosomes; XoGlo\u00ae; which are isolated; neonatal; mesenchymal stem cell-derived extracellular vesicles at a dose of 0.2 mg/kg each in a total of 15ml on day 1 and day 3. Control: 15ml of saline; i.v. on Day 1 and Day 3", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Intervention:", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Control:", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 788, "treatment_name": "Mesenchymal stem cells exosomes", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]