CELL INTELLIGENCE · 肿瘤细胞治疗研究

Inclusion Criteria:

1. Age greater than or equal 18 years.
2. Participants with chest x-ray findings concerning for pneumonia from any cause, with clinical signs suggestive of at least moderate illness such as respiratory rate \>20 breaths per minute or with oxygen saturation less than 93% on room air\*\*
3. Participants with COVID-19 associated pneumonia must meet baseline categorization of Moderate, Severe or Critical COVID-19 per FDA Guidance for Industry COVID-19: Developing Drugs and Biologics Products for Treatment or Prevention, February 2021.
4. Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
5. Participant or legally authorized representative consent. Participants with diminished mental capacity may be allowed on to enroll on the study.
6. Because of the nature of COVID-19, participants enrolled on this study with COVID-19 associated pneumonia may have been previously enrolled in other IND trials for their cancer diagnosis or for COVID-19. These enrollments will not exclude them from enrollment to this study.

Exclusion Criteria:

* Moribund participants not expected to survive up to 48 hours
* Participants with severe chronic liver disease (Childs-Pugh score \> 10)
* Pregnant and/or lactating women
* Participants on extracorporeal membrane oxygenation

主要终点：Incidence of composite serious adverse events (Phase I) · Serious adverse events with be comprised of grade 3 or 4 graft versus host disease or death and will be estimated and reported overall and by group, along with 95% confidence intervals. · Within 30 days of the first mesenchymal stem cell (MSC) infusion；Patients alive without grade 3, 4 infusional toxicity (Phase II) · At day 30 post MSC infusion；Patients alive with grade 3 or 4 infusional toxicity (Phase II) · At day 30 post MSC infusion；Patients not alive (Phase II) · At day 30 post MSC infusion
次要终点：Proportion of successfully extubated patients who present intubated on ventilator support (Phase I)；Rate of successful progression to intubation in patients who require supplemental oxygen but who are otherwise able to breathe without assistance (Phase I)；Overall survival rate (Phase I)；Survival rate in patients who present intubated on ventilator support (Phase I)；Survival rate in patients who require supplemental oxygen but who are otherwise able to breathe without assistance (Phase I)；Clinical parameters (Phase I)；Oxygenation parameters (Phase I)；Respiratory parameters (Phase I)

• Phase II Arm I (mesenchymal stem cells) · EXPERIMENTAL · Patients receive MSCs as in the Pilot study.
• Phase II Arm II (standard of care) · ACTIVE_COMPARATOR · Patients receive standard of care.
• Pilot study (mesenchymal stem cells) · EXPERIMENTAL · Patients receive MSCs IV over 1-2 hours on day 1. Patients may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.

This is a phase I trial followed by a phase II randomized trial. The purpose of phase I study is the feasibility of treating patients with acute respiratory distress syndrome (ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stem cells (MSC). The purpose of the phase II trial is to compare the effect of MSC with standard of care in these patients. MSCs are a type of stem cells that can be taken from umbilical cord blood and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs being used for infusion in this trial are collected from healthy, unrelated donors and are stored and grown in a laboratory. Giving MSC infusions may help control the symptoms of COVID-19 related ARDS.