Q Therapeutics announced it has received clearance from the FDA to launch a Phase 1/2 clinical trial in people diagnosed with ALS. The company is organizing the clinical trial, but has not yet opened it for enrollment. The trial will likely be a small one, with the specific aim of determining the safety of the use of their product, called Q-Cells®, in people diagnosed with ALS. Their Q Cell technology produces cells, called glia restricted progenitor cells, which can then be placed into the central nervous system, potentially then replacing glia cells which have been reported to be lost in neurodegenerative diseases such as ALS. 

There are many different types of glia cells, including the astrocytes, microglia, Schwann cells and oligodendrocytes whose behavior and population sizes been found to be altered in both animal models of ALS and people diagnosed with ALS. There are several cell-based therapeutic clinical trials in ALS today, including those operated by the Mayo Clinic, Neuralstem and Brainstorm.  While each approach is different, the cells produced and being used by Q Therapeutics are glial progenitors that give rise to the glial cells. One hope of this clinical trial is that implanted glia progenitor cells will be able to differentiate into the types of glia crucial to CNS health, such as astrocytes and oligodendrocytes. In turn, these cells could replace lost support in the CNS, thus affecting disease progression. However, until clinical trials are completed and data analyzed using Q-Cells®, such an outcome is not known.

(IMAGE: a glia-restricted progenitor cell. Source: Q Therapeutic's press release)

Is this trial open for enrollment?

No. The clinical trial is not currently open for enrollment, and clinical trial design was not announced. However, according to a company spokesperson, Q Therapeutics plans to initiate the clinical trial within months and will provide more information about its design and aims as enrollment sites are confirmed following individual institutional review board (IRB) approvals. They are directing thsoe interested in the trial to clinicaltrials.gov for more information as the trial comes together.  The ALS Therapy Development Institute will continue to monitor Q Therapeutics’ progress toward enrollment and will add information about this early stage clinical trial to our global database of ALS-specific clinical trials as is it becomes available.

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