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Stempeutics Research Pvt Ltd, a Bengaluru-based company working on stem-cell-based treatment and Slovenia-based Educell Ltd, which focusses on the development of cell therapy products, will tie up for the clinical trials of ‘Stempeucel’ for Covid-19 indications.
Stempeucel has been approved by the Drug Controller General of India (DGCI) for the treatment of CLI due to Buerger’s Disease and Atherosclerotic Peripheral Arterial Disease. Stempeutics is now planning, with Educell, to initiate clinical trials of the drug for Covid-19 related infections in India and Eastern Europe. Stempeutics is part of the Manipal Education and Medical Group, which runs hospitals and medical colleges.
Stempeutics and Educell are buoyed by the recent agreement signed by Novartis and Mesoblast for the development, manufacture and commercialisation of mesenchymal stromal cells (MSC).
“The recent agreement of the pharma majors gives us confidence, especially for us at Stempeutics, as we are working on developing cell therapy-based products,” Manohar BN, MD & CEO of the company told BusinessLine.
The company came across Educell through the consortium of stem cell companies that joined to conduct trials in Europe using MSCs. “We thought we should join this global effort. Here we are going to supply clinical-grade MSCs manufactured in our Manipal GMP facility, which is approved by the DCGI,” he said.
Manohar said Stempucel can be used on patients who have tested positive for Covid-19. “However, initial-stage patients may get relief by symptomatic treatment. As the patient load is too much, and access to MSC treatment is going to be limited, it would be advisable to use it in advanced-stage patients like those with Acute Respiratory Distress Syndrome (ARDS), who are on ventilator support.”
Developments in December
“We are signing an agreement later this month with Educell and will also partner with them to take our Stempeucel for clinical trials. The partnership will be for the Covid-19 related infections. Will see what can be done in India and also in Europe by Educell,” Manohar said.
“Stempeutics has also approached Educell to fund part of the trial in India along with the trials in Eastern Europe. If it works out, Educell will monitor in Eastern Europe and while we will monitor trials in India,” he added.
The partnership is set to begin later this month, and so far around $5,00,000 has been raised to initiate the clinical trials. “We have shipped our drugs to Slovenia and they are to conduct quality checks... So far, they have expressed satisfaction with our product quality,” said Manohar.
The quality check on Stempeutics’ facility was done in June and Educell studied the company’s documentations of good manufacturing practices and the various approvals it has received. “We shared all the documentation, and now based on all these parameters both the companies are partnering to initiate clinical trials,” he said.
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