The MEND (MEseNchymal coviD-19) Trial: a pilot study to investigate early efficacy of mesenchymal stem cells in adults with respiratory failure due to COVID-19 or another underlying condition.

Phase 1

Completed

• Conditions: COVID-19; ARDS; Respiratory - Other respiratory disorders / diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12620000612910
• Lead Sponsor: Cynata Therapeutics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-25
• Study Completion: 2022-05-14
• Last Update Posted: 17 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Male or female, 18 years of age or older
2. Respiratory failure with the following signs and symptoms:
P/F ratio <300 mmHg
Onset within one week of insult or new or worsening respiratory symptoms.
Chest imaging shows bilateral opacities, which are not fully explained by effusions,
lobar/lung collapse, or nodules.
3. Respiratory failure which is not fully explained by cardiac failure or fluid overload.
4. Onset of respiratory failure (as defined in inclusion criterion 2) within the past 48 hours.

Exclusion Criteria

1. <18 years of age
2. Patient is known to be pregnant
3. Known active malignancy that required treatment in the last year
4. WHO (2019) Class III, IV or V pulmonary hypertension
5. Venous thromboembolism currently receiving anti-coagulation or within the past 3 months
6. Currently receiving extracorporeal life support
7. Severe chronic liver disease (Child-Pugh score >12)
8. Do Not Attempt Resuscitation” order in place
9. Treatment withdrawal imminent within 24 hours
10. BMI > 45 kg/m2.
11. Received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned administration of study treatment.
12. Known positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B virus, Hepatitis C virus or any other infection which the opinion of the Investigator is likely to impact on the ability of the patient to participate in the study.
13. Known sensitivity to DMSO or any other component of the study treatments.

Study & Design

• Study Type: Interventional
• Study Design: Not specified