Hope on Covid-19 as Queen's University Belfast Leads Cell Therapy Trials

Even as the number of Covid-19, also known as Coronavirus, cases has reached nine in Malawi, there is hope that those who catch develop may soon live without the anguish, pain and helplessness associated with Acute Respiratory Distress Syndrome (ARDS).

Researchers at Queen's University Belfast, who are leading a United Kingdom (UK)-wide clinical trial to help improve outcomes in Covid-19 patients, have been looking into the possibility of developing an "innovative" cell therapy treatment for patients with acute respiratory failure.

The development comes at a time Health Minister Jappie Mhango has announced that, as of Friday, Malawi had nine Covid-19 cases.

He identified the latest individual to test positive for Coronavirus as a a 44-year-old man, originally from Burundi, with Canadian citizenship.

The man, a resident of Area 25B in Lilongwe, jetted in the country on March 28 2020 from Canada.

Malawi has registered one death from Covid-19 but, with Queen's University Belfast announcing that it has embarked on a clinical trial, led by professors Danny McAuley and Cecilia O’Kane, both researchers from the Wellcome-Wolfson Institute for Experimental Medicine at Queen’s, there is hope that countries with low death rates such as Malawi may not register more cases of death arising from ARDS.

The university indicates in a statement released on Saturday that the experts are investigating the use of allogenic Mesenchymal stromal cells (MSCs) in patients with ARDS complications caused by Covid-19.

"In the most critically unwell patients with Covid-19, many develop a complication known as ARDS. In ARDS the lungs become inflamed and leaky so they fill with fluid. This causes respiratory failure and patients may require admission to intensive care and a ventilator machine to support their breathing," the statement reads.

A recent statement from four UK chief Medical Officers outlined the importance of clinical trials amidst the Covid-19 crisis.

Professor Cecilia O’Kane said: “It is only through clinical trials we will be able to determine if new treatments are effective and safe in critically ill patients.”

The trial involves the use of MSCs, a type of cell derived from human tissue such as bone marrow or umbilical cord-- which is otherwise discarded after the baby is born-- to treat the injury to the lung caused by Covid-19.

MSCs are a novel treatment that have been shown in experimental models to reduce inflammation, fight infection and improve the repair of injured tissue.

Patients in this trial, which is known as 'Realist Covid-19, will be treated with a purified population of MSCs derived from umbilical cord tissue called ORBCEL-C. The ORBCEL-C therapy has been developed by scientists at Orbsen Therapeutics in Galway, Ireland. The ORBCEL-C therapeutic is manufactured under licence by the UK NHS Blood and Transplant Service for the 'Realist Covid-19' trial.

The trial is being introduced as part of an existing programme of research investigating the use of MSCs in patients with ARDS. The first patient has now been recruited with plans to recruit at least 60 patients throughout the Covid-19 pandemic at multiple sites across the UK including Belfast, Birmingham and London.

Professor Ian Young, Clinical Professor at the Centre for Public Health, Queen’s University Belfast, Director of HSC R&D and Chief Scientific Advisor at the Department of Health, said: “The Health and Social Care Research and Development Division has been working with researchers across HSC to address the global problem of Coronavirus.  We have contributed £230K for this vital research which will provide important evidence regarding a potential new treatment for respiratory failure, a leading cause of mortality in COVID-19.

"We will continue to support health research and encourage people to participate in research trials and other studies so patients can get the best possible treatment to help tackle the spread of COVID-19.”

The trial has been identified by the National Institute for Health Research (NIHR) as a national urgent public health study. It is one of a number of Covid-19 studies that have been given urgent public health research status by the Chief Medical Officer/ Deputy Chief Medical Officer for England.

The study is funded by the Health and Social Care Research and Development Division and the Wellcome Trust, sponsored by the Belfast Health and Social Care Trust and supported by the NI Clinical Trials Unit, the NIHR Clinical Research Network and the Northern Ireland Clinical Research Network.

Orbsen CSO Steve Elliman noted: “While there are over 100 vaccines and therapies in development targeting the SARS-CoV-2 infection - at present there are no disease modifying therapies approved for ARDS.  We’re delighted the REALIST trial was approved and listed by NIHR as an Urgent Public Health Research Study so we can continue assess the safety of the ORBCEL-C therapy in patients with ARDS.”

Sir Professor Alimuddin Zumla of University College London, a global coronavirus and infectious diseases expert, said: “This is an exciting and important trial which targets rectifying the underlying causes of lung damage and has great potential of saving many lives from COVID-19. The team should be congratulated for their leadership of host-directed therapies, a concept which has not yet been explored to its full potential.”

Professor Danny McAuley is also part of an international network of researchers who are taking forward trials of umbilical cord-derived Mesenchymal stromal cells for the treatment of Covid-19: UK: (UCL- Sir Professor Azumla); Portugal (Champualimud Foundation - Professor Markus Maurer; Italy (INMI-Professor Giuseppe Ippolito) and China (Fifth Medical Center- Professor Fu-Sheng Wang.)

President Peter Mutharika recently declared that Malawi was in a 'state of disaster' in the wake of the threat posed by Coronavirus.

A press statement which the Ministry of Justice and Constitutional Affairs released on April 6 backed the President's decision.

PRESS RELEASE

DECLARATION OF STATE OF DISASTER BY HIS EXCELLENCY, THE PRESIDENT

The Ministry of Justice and Constitutional affairs wishes to assure the nation that the Declaration of the State of Disaster with respect to the Corona Virus Disease (COVID-19) made by His Excellency, the President on 20th March, 2020 was made in accordance with section 32 of the Disaster Preparedness and Relief Act (Cap. 33:05 of the Laws of Malaŵi) which provides as follows:
    “Declaration of a State of Disaster

32.—(1) If at any time it appears to the President that any disaster is of such a nature and extent that extraordinary measures are necessary to assist and protect the persons affected or likely to be affected by the disaster in any area within Malaŵi or that circumstances are likely to arise making such measures necessary, the President may, in such manner as he considers fit, declare that, with effect from a date specified by him in the declaration, a state of disaster exists within an area defined by him in the declaration:
Provided that where such declaration has been made in any manner other than by notice in the Gazette, the President shall, as soon as possible after making it, cause it to be published in the Gazette.

(2) The declaration of a state of disaster under subsection (1) shall remain in force for a period of three months from the date specified in the declaration as the commencement date of the state of disaster, unless the President by notice in the Gazette, withdraws such declaration before the expiry of such period:
Provided that the President may, from time to time, extend or further extend such period by not more than another three months and shall do so by notice in the Gazette, published before the expiry of such period or any such extension thereof.”

In making the Declaration, the President complied with section 32 of the Act and as required by that provision, caused the said declaration to be published in the Gazette as Government Notice No. 4 in the Malaŵi Gazette Supplement of 3rd April, 2020. Further, the Ministry wishes to state that the Disaster Preparedness and Relief Act does not preclude the President, as head of State and Government, from announcing any of the extraordinary measures as are necessary to assist and protect persons affected or likely to be affected by the disaster so declared.

Dated this 6th day of April 2020

PILIRANI MASANJALA
PUBLIC RELATIONS OFFICER
MINISTRY OF JUSTICE AND CONSTITUTIONAL AFFAIRS

However, as Covid-19 shakes people's faith in leaders' decision, there is no time for vain delays.