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Area of Science:

  • Hematology
  • Biotechnology
  • Regenerative Medicine

Background:

  • Clinical-grade bone marrow processing is crucial for allogeneic haematopoietic stem cell transplantation (HSCT) and regenerative medicine.
  • ABO-mismatched HSCT and regenerative medicine applications necessitate efficient bone marrow processing.

Purpose of the Study:

  • To evaluate the efficacy of a fully automated, closed clinical-grade system (Sepax) for bone marrow processing.
  • To assess Sepax system performance in buffy-coat production for HSCT, orthopaedic regenerative medicine, and critical limb ischemia treatment.

Main Methods:

  • A single-center experience analyzing 125 Sepax procedures from 2003-2015.
  • Procedures included buffy-coat production for HSCT, regenerative medicine, and density-gradient separation.
  • Evaluation of Sepax2 with SmartRedux software for enhanced red blood cell depletion.

Main Results:

  • Sepax achieved significant volume reduction (85%) and CD34 cell recovery (96%) for HSCT buffy coats.
  • The SmartRedux software improved volume reduction (90%) and red blood cell depletion (88%).
  • Density gradient separation ensured complete red blood cell depletion with high CD34 recovery (69%); no product-related reactions or contamination were reported.

Conclusions:

  • Automated bone marrow manipulation with Sepax is effective and provides operator-independent results.
  • The Sepax system is suitable for a wide range of clinical applications, including HSCT and regenerative medicine.
  • Clinical-grade automated processing ensures product quality and safety for patient treatments.