Stem cell therapies and strokes

Stroke remains one of the major causes of death and disability worldwide. Due to the limited time window for the administration of the only thrombolytic agent, alteplase, only a minority of stroke victims receive this medical therapy. The majority end up with mere palliative care to alleviate the symptoms associated with ischemic brain damage.

AIS is the most common type of stroke, and is caused by a blockage of the blood flow to the brain, leaving the affected part of the brain deprived of oxygen and nutrients. This eventually causes the destruction of brain cells, neuronal connections, and vascular systems with devastating complications. Approximately 25% of patients have neurological deterioration during the first 24–48 hours after stroke, and it is difficult to predict which patients will worsen.

Athersys is developing MultiStem cell therapy in collaboration with Healios. MultiStem consists of undifferentiated human adult stem cells that have the unique ability to promote tissue repair and healing in a variety of ways, including the expression of factors that regulate the immune system, and the formation of multiple cell types.

The Phase II safety and efficacy of multipotent adult progenitor cells in AIS trial (MASTERS) demonstrated that MultiStem was safe and well tolerated, with no infusional or allergic reactions. Although this trial did not demonstrate better global stroke recovery between the MultiStem and placebo groups when administered within 24-48 hours of symptom onset, Healios is planning to initiate a Phase III trial (MASTERS-2) investigating global stroke recovery in an earlier time window—within 18–36 hours after the onset of ischemic stroke.

A Phase II/III trial of MultiStem in AIS (TREASURE) is ongoing in Japan where subjects receive a single dose of 1.2 billion HLCM051 (MultiStem) cells administered within 18–36 hours after the onset of ischemic stroke. A recently announced binding letter of intent (LOI) between Athersys and Healios stated that the companies will expand the collaboration between the existing partners to develop and commercialise the product in extended indications in Japan and China, and provide Athersys with the capital to support its Phase III study in North America and Europe.

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anonymous Thoughts March 13, 2020 at 10:56 am 1 0