Prochymal is a
stem cell therapy
Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. , the only established therapy using stem cells is hematopoietic stem cell transplantation. This usually takes the form of a bone-marrow transplantation, bu ...
made by
Osiris Therapeutics
Osiris Therapeutics, Inc. was founded in March 1993 following the identification of mesenchymal stem cells (MSCs) by Dr. Arnold Caplan and colleagues at Case Western Reserve University in Cleveland Ohio.
----Second part of article:Cell research l ...
. It is the first
stem cell
In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can differentiate into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type of ...
therapy approved by Canada. It is also the first therapy approved by Canada for acute
graft-vs-host disease
Graft-versus-host disease (GvHD) is a syndrome, characterized by inflammation in different organs. GvHD is commonly associated with bone marrow transplants and stem cell transplants.
White blood cells of the donor's immune system which remain wit ...
(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.
Mese ...
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
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 cel ...
, 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; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the department of the Government of Canada responsible for national health polic ...
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 colo ...
provided sufficient evidence for the
FDA 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.
[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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