Read highlights from the latest installment of Dusko Ilic’s industry news, which discuss the latest developments and news in regenerative medicine and stem cell research, and are published every month in Regenerative Medicine.
Every month, Dusko comments on regenerative medicine industry news of note. Read the full update for April 2020 in Regenerative Medicine here>>
What happened this month that you were expecting?
A number of companies worldwide are trying to jump on the COVID band wagon and make some money out of it; stem cell companies are no exception. Indeed, there is a theoretical possibility that a mesenchymal stromal/stem cell (MSC)-based therapy might work in some cases.
MSCs do work as therapy for acute graft-versus-host-disease (GvHD), the major complication of allogeneic bone marrow transplantation. In GvHD, most of clinical manifestations are the result of dysregulated production of cytokines, causing a so-called cytokine storm or inflammatory storm.
Cytokines are molecules that guide a healthy immune response; however, in a cytokine storm, some of them are produced in excess of what is needed, breaking the balance of the cytokine network. Such perturbation can damage target organs and lead to death. Some studies have shown elevated levels of these inflammation-induced cytokines in the blood of COVID-19 patients. That initiated a quick conclusion associating COVID-19 with hyperinflammatory states and, as such, an approach suppressing hyperimmune response would be the way to go for therapy. As in GvHD, MSCs might help in this case.
However, there is still not enough data that a cytokine storm is the underlying cause of death in COVID patients and, even if it is, certainly not in all of them. Furthermore, we do not know yet all the features of the virus-induced inflammation and its consequences on the patient immune system. We also do not know if the anti-inflammatory repertoire produced by MSCs may fuel the processes triggered by the virus, such as the activation of the clotting system and facilitation of viral replication.
There is definitely a need for a properly designed study before any conclusion can be made.
What happened that surprised you this month?
I do understand that a treatment for COVID-19 is desperately needed. It is also plausible that MSC might work in some cases. However, some of the proposed treatments left me speechless. Hope Biosciences Stem Cell Research Foundation (TX, USA) announced a clinical trial focused on frontline workers. Included will be doctors, nurses and staff who are at a higher risk of exposure. Participants will receive five infusions of allogeneic adipose-derived mesenchymal stem cells (adMSCs) with the purpose of providing immune support against COVID-19. A hundred participants will be divided into four arms. Three will receive intravenous infusions of Hope Bioscience’s (HB) adMSC (HB-adMSC) at 50, 100 or 200 million cells/dose. The fourth arm will receive saline as a placebo.
The surprising part is that, according to the HB’s press release, the study has been FDA-approved.
If we only read about one story this month, what should it be?
Mesoblast (Melbourne, Australia) has announced 83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated during the period March-April 2020 with two intravenous infusions of Mesoblast’s allogeneic MSC product candidate, remestemcel-L, within the first five days. 75% (9/12) have successfully come off ventilator support at a median of 10 days. Patients received a variety of experimental agents prior to remestemcel-L and all patients were treated under an emergency Investigational New Drug (IND) application or expanded access protocol at New York City’s Mount Sinai Hospital (NY, USA).
In contrast, only 9% (38/445) of ventilator-dependent COVID-19 patients at a major referral hospital network in New York City were able to come off ventilator support when treated with standard of care during March/April 2020. Moreover, there was 88% mortality with only 12% survival (38/320) among ventilator-dependent COVID-19 patients at a second major referral hospital network in New York City during the same period.
Dusko Ilic is a Senior Lecturer in stem cell science, coordinator of the cross-divisional postgraduate program in stem cells and regenerative medicine, and Head of the Induced Pluripotent Stem Cell Core Facility at King’s College London (London, UK). He is also Head of the Assisted Conception Unit’s Human Embryonic Laboratories at Guy’s Hospital (London, UK). He is also a member of the editorial board of the journal Regenerative Medicine, where he writes the Industry Report, a regular feature compiling information from non-academic institutions in the field of stem cells and regenerative medicine.