A global consortium of stem cell companies, which includes an Indian stem cell company, Stempeutics is expected to be among the first to come out with a drug for end-stage coronavirus patients. The drug is expected to be in the market within the next 12 months. Stempeutics, which is part of the multi-billion dollar Manipal Education and Medical Group which runs hospitals and medical colleges, has also approached the Drug Controller General of India (DCGI) to offer a stem-cell-based product as a treatment for patients with novel coronavirus infection with signs of severe disease.

The Stempeucell is derived from human bone marrow as candidate therapy. This product has already been used in India in clinical trials to treat patients with diabetic foot ulcer and two other conditions. The product is being pitched as an anti-Covid-19 drug for its anti-inflammatory properties. In a conversation with BusinessLine , Stempeutics’ CEO and MD, BN Manohar, explains the company’s Covid-19 initiatives. Excerpts:

How did this collaboration come about? What role does Stempeutics play in this consortium?

We have been exploring opportunities to conduct a clinical trial in India on Covid-19 using our MSCs (Mesenchymal Stem Cells: multipotent stem cells found in the bone marrow that are important for making and repairing skeletal tissues) and we are in touch with ICMR (Indian Council of Medical Research) and DCGI on this. Meanwhile, we came to know about this consortium of stem cell companies joining together to conduct a trial in Europe using MSCs and we thought we should join this global effort. We are going to supply clinical-grade MSCs manufactured in our Manipal GMP facility which is approved by DCGI.

You mentioned about developing a drug for end-stage victims. Can the same be used for all those who have tested positive?

Technically, yes, it can be used for all those who have tested positive. However, the initial stage patients may get relief by symptomatic treatment. As the patient load is too much and availability to MSC treatment is going to be limited, it would be advisable to use it in advanced-stage patients like Acute Respiratory Distress Syndrome (ARDS) (who are under ventilator support).

The company claims Stempeucel will reduce the fatal symptoms of Covid-19-induced pneumonia and its progression to ARDS. Has it been scientifically validated? Was any human trial conducted for the same?

We are yet to test Stempeucel in ARDS due to Covid-19 induced pneumonia. It has been observed that Covid-19 viral germs can induce severe pulmonary inflammation in the lungs. When the lungs become inflamed, they accumulate fluid and the lungs tissues become structurally abnormal and its function is significantly compromised. Normal oxygenation is prevented resulting in serious illness as well as death in some patients. Also, some patients frequently experience long term pulmonary damage due to ventilator-induced fibrosis and scarring.

Stempeucel MSCs may address these issues because, firstly, it has anti-inflammatory effects on host cells, secondly, it increased rate of fluid clearance in the lung, there is reduction in alveoli damage, and finally, enhancement of host mononuclear cells to protect the body against harmful foreign particles. We expect that it may take about 8 to 9 months for us to complete the testing of Stempeucel on ARDS patients. We are planning to measure mechanical ventilator-free days and reduction in mortality rate after administration of Stempeucel drug.

Is it permitted by the FDA and other regulatory agencies to fast-track the entire process of validation?

Yes. Different regulatory agencies have different approaches. However, all agencies around the globe are working hard to fast track the studies if sufficient safety data is available on the test product.

There are reports about how the BCG vaccine can be used for treating patients with coronavirus. Do you think it is good enough?

BCG vaccine was developed about 100 years ago to fight tuberculosis. This vaccine prevents infant deaths from a variety of causes and sharply reduces the incidence of respiratory infections. There is no evidence that it will work against coronavirus infection, hence it is now being tested against the coronavirus infection.

Which are the other areas Stempeucel has been useful for treating patients?

Currently, we are focussing on four indications — Critical Limb Ischemia (CLI) (blockage in the arteries of the limb), osteoarthritis, diabetic foot ulcer and peri-anal fistula due to Chron’s Disease. All studies are approved by DCGI. Critical Limb Ischemia (CLI) is in an advanced stage of marketing approval.

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