Mesenchymal stromal cell (MSC) therapy for COVID-19 pneumonia

Phase I trial on safety and tolerability of bone-marrow derived mesenchymal stromal cells (MSC) for deteriorating COVID-19 pneumonia

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000840987

Acronym

MSCCOVIDP

Enrollment

Registered

2020-08-26

Start date

2020-05-05

Completion date

2020-12-30

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The cytokine storm, resulting from the extreme immune response to COVID-19 virus, has been identified as the key event that leads to the acute respiratory distress and multiple organ damage, eventually leading to death in COVID-19 infection. The cell therapy, mesenchymal stromal cells (MSC), secrete anti-inflammatory factors that can prevent the cytokine storm. The first published report of 7 patients with severe COVID-19 pneumonia showed that MSC therapy was able to change the inflammatory status of severely ill patients and significantly improve pulmonary function. The small study demonstrated that MSC therapy was safe and effective in severe COVID-19 pneumonia. Our centre manufactures an allogeneic MSC product, under licence from Isopogen Pty Ltd, that is cryopreserved for off-the-shelf use. No donor matching is required and the MSC have natural immunity to COVID-19. The objective of this study is to identify and treat deteriorating COVID-19 patients with MSC therapy to attenuate the cytokine storm response to the COVID-19 virus and thus prevent acute respiratory distress and multi organ damage, improving chance of survival. This is an open label trial, planned to recruit and consent 10 high risk patients on admission. Patients will receive MSC infusions if they are COVID-19 positive and have increasing oxygen requirements to maintain O2 sat of >92%. The primary study endpoint is safety, with secondary endpoints of clinical parameter assessment, including oxygen requirements, ventilatory support, ICU admission, length of stay, survival and the effect of treatment on inflammatory markers.

Interventions

Allogeneic, bone marrow derived, culture expanded mesenchymal stromal cells Dose: 2 x 10^6 cells/kg patient weight Duration: day 0 and day 3 Mode: intravenous administration Administered by: respiratory physcian Intervention recorded in patient charts, on product infusion records and in product tracking records.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Confirmed bi-lateral pneumonia on chest X-ray Confirmed COVID-19 infection Worsening hypoxia with an increasing oxygen requirement by 2L/min (Hudson mask or nasal prongs) to maintain SaO2>92%, measured on 2 occasions over >2 hours or requiring more than 4L/min to maintain SaO2>92% with no history suggestive of chronic hypoxia. Planned for active treatment with goals of care category A, B or C, including those not eligible for ICU transfer.

Exclusion criteria

Life expectancy < 48 hours or GOPC D (palliation only). Any condition that in the opinion of the investigator may interfere with the safety of the patient or evaluation of study objectives. Unable to provide consent. Recent therapy within the last 3 months with immunomodulatory agents including monoclonal antibodies and anti-neoplastics. Age <18 years Enrolled in another interventional trial.

Outcome results