Phase 3 Cell Therapy clinical trial for stress urinary incontinence

cell therapyBioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers (“BioLife” or the “Company”),  has announced that its media products are embedded into the autologous cell therapy being developed by Pittsburgh-based Cook MyoSite, a subsidiary of the Cook Group, for treatment of female stress urinary incontinence.

In an ongoing phase 3 clinical trial, a muscle tissue biopsy is extracted from the patient and shipped to the Cook MyoSite processing lab, where the manufacturing process is completed. The manufactured dose is frozen and shipped back to the clinic, where the cells are thawed and injected back into the patient near the pelvic floor to improve bladder control, the company said in Bothell, Washington.

Ron Jankowski, Vice President of Product Development at Cook MyoSite, commented, “Biopreservation management is critical to the success of our therapeutic products.  We continue to gain confidence in our decision to incorporate BioLife’s comprehensive biopreservation management solutions into our clinical development and commercialization plans.”

Mike Rice, BioLife President & CEO, remarked, “We are very pleased to have a strong and long term relationship with Cook MyoSite.  Their use of our products in their manufacturing process represents the optimal approach to maximize control of sensitive biologic materials. We look forward to data readouts on this important clinical trial and to a potential approval for this life-changing cell-based therapy for millions of patients suffering from stress urinary incontinence.”

Based on early success of the technology, Cook MyoSite is expanding its manufacturing facility in RIDC park from about 21,000 to 66,000 square feet. The company is refurbishing a building next to its corporate offices, which will be redone to accommodate aseptic manufacturing practices and to create a global distribution center. Occupancy of the new building is expected by November. The company plans to invest at least $26 million into the project while continuing to explore use of its cell therapy platform for treatment of fecal incontinence and to restore tongue muscles weakened by radiation therapy.  Cook MyoSite anticipates adding approximately 50 employees over the next few years to accompany the facility expansion. –  PRNewswire

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