Prochymal is a
stem cell therapy made by
Osiris Therapeutics. It is the first
stem cell therapy approved by Canada. It is also the first therapy approved by Canada for acute
graft-vs-host disease (GvHD).
Also known as remestemcel-L, Prochymal was sold to Australia-based
Mesoblast
Mesoblast Limited is an Australian-based regenerative medicine company. It seeks to provide treatments for inflammatory ailments, cardiovascular disease and back pain. The company is led by Silviu Itescu, who founded the company in 2004.
Mes ...
in 2013 at which time its brand name was changed to Ryoncil.
It is an
allogeneic stem therapy based on
mesenchymal stem cells (also medicinal signalling cells,
mesenchymal stromal cells, and MSCs) derived from the bone marrow of adult donors. MSCs are purified from the marrow, cultured and packaged, with up to 10,000 doses derived from a single donor. The doses are stored frozen until needed.
Approvals and indications
In May 2012
Health Canada approved the use of remestemcel-L (Prochymal) for the management of acute GvHD in children who are unresponsive to steroids, with the approval conditional upon further trials being conducted.
Separately, a pilot study of Ryoncil on ventilator-assisted COVID-19 patients with
Acute Respiratory Distress Syndrome provided sufficient evidence for the
FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
to approve a Phase 2/3 placebo-controlled trial on 300 patients. That trial commenced enrollment on May 5, 2020. It is being overseen by Mount Sinai Hospital and the Cardiothoracic Clinical Trials Network and funded by the
National Institutes of Health
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
.
[Sheikh, Knvul and Thomas, Katie. More Coronavirus Vaccines and Treatments Head Toward Human Trials. April 8, 2020, May 2, 2020]
Clinical trials
Preliminary results of a phase III trial for GvHD were released in Sept 2009.
See also
*
Cell therapy
Cell therapy (also called cellular therapy, cell transplantation, or cytotherapy) is a therapy in which viable cells are injected, grafted or implanted into a patient in order to effectuate a medicinal effect, for example, by transplanting T-c ...
References
Biotechnology
Stem cells
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