Prochymal is a
stem cell therapy made by
Osiris Therapeutics
Osiris Therapeutics, Inc. was an American company founded in March 1993 following the identification of Mesenchymal stem cell, mesenchymal stem cells (MSCs) by Dr. Arnold Caplan and colleagues at Case Western Reserve University in Cleveland, Ohio. ...
. It is the first
stem cell
In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can change into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type of 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 in 2013 at which time its brand name was changed to Ryoncil.
It is an
allogeneic stem therapy based on
mesenchymal stem cells
Mesenchymal stem cells (MSCs), also known as mesenchymal stromal cells or medicinal signaling cells, are multipotent stromal cells that can differentiate into a variety of cell types, including osteoblasts (bone cells), chondrocytes (cartilage ...
(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
Health Canada (HC; )Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary units, department of the Gove ...
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
Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. Symptoms include shortness of breath (dyspnea), rapid breathing (tachypnea), and bluish skin co ...
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 (NIH) is the primary agency of the United States government responsible for biomedical and public health research. It was founded in 1887 and is part of the United States Department of Health and Human Service ...
.
[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- ...
References
Biotechnology
Stem cells
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