The MEseNchymal coviD-19 Trial: MSCs in Adults With Respiratory Failure Due to COVID-19 or Another Underlying Cause

NCT ID: NCT04537351

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-24
• Study Completion Date: 2022-05-18

Brief Summary

This is a pilot, multi-centre, open-label randomised controlled study to assess the early efficacy of intravenous (IV) administration of CYP-001 in adults admitted to an intensive care unit (ICU) with respiratory failure

Detailed Description

After enrolment upon meeting eligibility criteria (D0), participants baseline data will be collected and participants will be randomised to receive either standard of care treatment only, or standard of care plus CYP-001. On D1 and D3, each participant randomised to receive CYP-001 will receive an IV infusion of 2 million Cymerus mesenchymal stem cells (MSCs)/kg of body weight (up to a maximum of 200 million cells). Participants will have further data collection throughout their ICU and hospital stay and follow up to 28 days.

Conditions

Covid19; Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CYP-001

The investigational medicinal product used in this study is known as CYP-001. The active agent in CYP-001 is Cymerus™ MSCs. CYP-001 is supplied as 100 million Cymerus MSCs formulated in 20 mL cryoprotectant medium. On D1 and D3, each participant randomised to receive CYP-001 will receive an IV infusion of 2 million Cymerus MSCs/kg of body weight (up to a maximum of 200 million cells per infusion).

Group Type: EXPERIMENTAL

CYP-001

Intervention Type: BIOLOGICAL

The active agent in CYP-001 is Cymerus mesenchymal stem cells (MSCs), which are derived through a proprietary induced pluripotent stem cell (iPSC) and mesenchymoangioblast (MCA)-derived production process.

Standard of care

Control participants will be randomised to received standard of care treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CYP-001

The active agent in CYP-001 is Cymerus mesenchymal stem cells (MSCs), which are derived through a proprietary induced pluripotent stem cell (iPSC) and mesenchymoangioblast (MCA)-derived production process.

Intervention Type: BIOLOGICAL

Other Intervention Names

Cymerus MSCs

Eligibility Criteria

Inclusion Criteria

• Male or female, 18 years of age or older
• Respiratory failure with the following signs and symptoms:

1. P/F ratio <300 mmHg

2. Onset within one week of a known insult or new or worsening respiratory symptoms.

3. Chest imaging shows bilateral opacities, which are not fully explained by effusions, lobar/lung collapse, or nodules.

• Respiratory failure which is not fully explained by cardiac failure or fluid overload.
• Onset of respiratory failure within the past 48 hours (as defined in inclusion criterion 2

Exclusion Criteria

• <18 years of age
• Patient is known to be pregnant
• Known active malignancy that required treatment in the last year
• WHO Class III or IV pulmonary hypertension
• Venous thromboembolism currently receiving anti-coagulation or within the past 3 months
• Currently receiving extracorporeal life support
• Severe chronic liver disease (Child-Pugh score >12)
• "Do Not Attempt Resuscitation" order in place
• Treatment withdrawal imminent within 24 hours
• BMI > 45 kg/m2.
• 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.
• 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.
• Known sensitivity to dimethylsulfoxide (DMSO) or any other component of the study treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cerebral Palsy Alliance

OTHER

Sponsor Role: collaborator

Cynata Therapeutics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jolanta Airey, MD

Role: STUDY_DIRECTOR

Cynata Therapeutics Limited

Locations

Nepean Hospital

Kingswood, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Footscray Hospital

Footscray, Victoria, Australia

Sunshine Hospital

Saint Albans, Victoria, Australia

Countries

Australia

Other Identifiers

CYP-COVID-19-01

Identifier Type: -

Identifier Source: org_study_id