Use of UC-MSCs for COVID-19 Patients

Camillo Ricordi

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19; Corona Virus Infection; Acute Respiratory Distress Syndrome; ARDS, Human; ARDS

Treatments: Biological: Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.; Other: Vehicle + Heparin along with best supportive care

Study type: Interventional

Funder types: Other

Identifiers

NCT04355728

20200671

20200370 (Other Identifier)

Details and patient eligibility

About

The purpose of this research study is to learn about the safety and efficacy of human umbilical cord derived Mesenchymal Stem Cells (UC-MSC) for treatment of COVID-19 Patients with Severe Complications of Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS).

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients >/= 18 years old diagnosed with COVID-19 (as evaluated by PCR test confirming infection with SARS-CoV-2) will be eligible for inclusion if they meet all of the below criteria. Inclusion criteria must all be present within a 24-hour time period at the time of enrollment:

1. Patient currently hospitalized
2. Aged ≥ 18 years
3. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
4. Peripheral capillary oxygen saturation (SpO2) ≤ 94% at room air, or requiring supplemental oxygen at screening
5. PaO2/FiO2 ratio < 300 mmHg
6. Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan
7. Hypoxemia requiring an increase in the fraction of inspired oxygen (FiO2) of ≥ 20% AND an increase in positive end-expiratory airway pressure (PEEP) level of 5 cm H2O or more to maintain transcutaneous oxygen saturations in the target range of 88-95%, or requirement for escalation from oxygen therapy to invasive mechanical ventilation

Exclusion criteria

1. PaO2/FiO2 ≥ 300 at the time of enrollment
2. A previous MSC infusion not related to this trial
3. History of Pulmonary Hypertension (WHO Class III/IV)
4. History of left atrial hypertension or decompensated left heart failure.
5. Pregnant or lactating patient
6. Unstable arrhythmia
7. Patients with previous lung transplant
8. Patients currently receiving chronic dialysis
9. Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO)
10. Presence of any active malignancy (except non-melanoma skin cancer)
11. Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
12. Moderate to severe liver disease (AST and ALT >5 X ULN)
13. Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen
14. Baseline QT prolongation
15. Moribund patient not expected to survive > 24 hours

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

UC-MSCs Group

Experimental group

Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Treatment:

Biological: Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.

Control Group

Placebo Comparator group

Description:

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Treatment:

Other: Vehicle + Heparin along with best supportive care