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

NCT04537351 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CYP-COVID-19-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

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

Conditions

Covid19; Acute Respiratory Distress Syndrome

Keywords

Mesenchymal stem cells; MSC; Induced pluripotent stem cells; iPSC; Cellular therapy

Outcome Measures

Primary Outcomes (1)

• Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups

  Assessment of respiratory dysfunction

  7 days

Secondary Outcomes (11)

• Incidence and severity of treatment-emergent adverse events

  28 days

• Change in C-reactive protein (CRP) levels

  7 days

• Proportional differences between groups on the Clinical Improvement Scale

  28 days

• Changes in P/F ratio

  28 days

• Changes in respiratory rate

  28 days

Study Arms (2)

CYP-001

EXPERIMENTAL

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).

Biological: CYP-001

Standard of care

NO INTERVENTION

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

Interventions

CYP-001 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.

Also known as: Cymerus MSCs

CYP-001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age or older
• Respiratory failure with the following signs and symptoms:
• P/F ratio \<300 mmHg
• Onset within one week of a known insult or new or worsening respiratory symptoms.
• 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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Cynata Therapeutics Limited: lead
• Cerebral Palsy Alliance: collaborator

Study Sites (5)

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

Location

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Footscray Hospital

Footscray, Victoria, 3011, Australia

Location

Sunshine Hospital

Saint Albans, Victoria, 3021, Australia

Location

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jolanta Airey, MD

  Cynata Therapeutics Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 3, 2020
• Study Start: August 24, 2020
• Primary Completion: April 27, 2022
• Study Completion: May 18, 2022
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data requests will be considered after the completion of the study. There is no specified end date.
• Access Criteria: All reasonable requests for raw and analysed data that are not included in primary publications from this study may be available upon request and discretion from the Sponsor from the beginning to the trial. Data may be made available to active collaborators in the COVID-19 Stem Cell Treatment (CSCT) Group, subject to permission from the Sponsor and ethics approval if required. All other reasonable requests for raw and analysed data will be considered by the Sponsor. Data may be obtained upon permission from the Sponsor.

Locations

AU (5)