Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated With the Novel Corona Virus Infection (COVID-19)

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Recent advances have been made in prevention of the viral infection via vaccines but there is still need for effective treatment options for patients. Novel therapies need to be developed to further improve clinical outcomes. The biggest medical challenge in the response to COVID-19 is ARDS requiring hospitalization in an intensive care setting and ventilator dependence. Intravenously administered umbilical cord derived exosomes and stem cells have been reported in literature to alleviate pulmonary distress in such patients.

The purpose of this study is to explore the safety and benefits of intravenous administration of WJPure and EVPure in the treatment of COVID-19 patients with moderate to severe ARDS. .

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

Details

• Lead Sponsor: Vitti Labs, LLC

Criteria

Inclusion Criteria:

• Subjects will be eligible for enrollment in the study only if they meet the following criteria:

1. Male or female, aged at 18 years (including) to 75 years old.

2. Patient with a confirmed SARS-CoV-2 infection (by positive reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal sample or any other sample)

3. Hospitalized with moderate to severe ARDS.

4. Have ARDS or acute lung injury, comply with any of the following:

i. Respiratory distress, Respiratory rate (RR) ≥ 30 times/min ii. Pulse oxygen saturation (SpO2) at rest ≤ 93% iii. Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤ 300mmHg

5. If childbearing age: agree to practice effective birth control from screening until 12 weeks after the last study treatment.

Exclusion Criteria:

• Subjects will be ineligible for enrollment in the study if they meet any of the following criteria:

1. Patient under invasive mechanical ventilation for more than 48 hours

2. Allergic or hypersensitive to any of the ingredients.

3. Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses.

4. Obstructive HABP/VABP induced by lung cancer or other known causes.

5. Carcinoid syndrome.

6. History of long-term use of immunosuppressive agents.

7. History of Class III or IV pulmonary arterial hypertension.

8. Patient with chronic respiratory disease under oxygen therapy.

9. Undergoing hemodialysis or peritoneal dialysis.

10. Estimated or actual rate of creatinine clearance < 15 mL/min.

11. History of moderate and severe liver disease (Child-Pugh score >12).

12. History of deep venous thrombosis or pulmonary embolism within the last 3 years.

13. Undergoing extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation support.

14. Patient included in another ongoing interventional therapeutic trial.

15. Pregnant or Lactating.

16. Any condition of unsuitable for the study determined by Principal Investigator (PI).