If the clinical trial is successful, the company p

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If the clinical trial is successful, the company plans to expand use of HemaXellerate I™ to other conditions associated with bone marrow dysfunction, with the overall goal of entering the hematopoietic growth factor market. This market is substantial in size and currently includes drugs such as Neupogen®, Neulasta®, Leukine® and Revolade®.
"Current drug-based approaches for healing bone marrow damage involve "flooding" the body with growth factors, which is extremely expensive and causes unintended consequences because of lack of selectivity," said Dr. Vladimir Bogin, CEO of Chromos Pharma (a contract research organization), which collaborated with Regen on filing the IND and member of the Company's Scientific Advisory Board. "Based on our data HemaXellerate I™ possesses the advantage delivering an optimized cellular mixture that produces the needed growth factors at the specific location in the bone marrow niche."
The planned clinical trial anticipates recruiting 10 patients who have failed standard of care, which will be treated with HemaXellerate I™ and followed for safety parameters and signals of efficacy. Therapeutic effects will be quantified based on immunological measurements, as well as improvement in blood counts. Patients in the trial will be assessed for one year, however, because the trial is unblinded, data will be available as the study progresses.

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