Tissue Genesis Icellerator Cell Isolation System® – Cell Therapy Automated System

Tissue Genesis is the first company to conduct an FDA-approved clinical trial for cell therapy using adipose-derived stem cells isolated at the point-of-care with an automated system. Their expertise, experience and innovation have put them at the forefront of the highly competitive regenerative medicine market.

Potential applications range from treatment of chronic and acute heart damage to aesthetics and reconstruction such as dermal fillers and breast augmentation. Regenerative medicine solutions may accelerate bone, muscle and cartilage repair for orthopedics, as well as provide potential solutions for erectile dysfunction and other genitourinary pelvic health disorders.

Service Provided by Sparton:

The design center team from Sparton was engaged by Tissue Genesis to review some system improvements originally designed by another third party. Sparton’s involvement escalated to perform extensive re-design, development, and manufacturing services, including:

  • Full system design

    • Firmware design around AVR and C
    • Electronics design around electrical safety to meet IEC60601 and IEC 61010
    • Software design around Windows OS and C/C+
    • Mechanical engineering around centrifuge, syringe pump drive, syringe pump control, temperature control of the syringe pump and centrifuge chamber
  • Prototype and initial volume production

Key Challenges:

  • Demonstrating experience and familiarity with both IEC 60601 and IEC 61010
  • Sparton’s familiarity and experience with safety and regulatory requirements
  • Firm understanding in mechanical design around temperature control systems and syringe actuators
  • Proven knowledge and capability with control software

End Result

Sparton’s familiarity and experience to identify system re-design needs helped the client to realize the design center’s full spectrum of expertise and deliver an FDA regulated device that was positioned to win FDA approval for clinical trials. The innovative compact design allows for easy mobility and efficient use of space in an operating room.  In about an hour, millions of regenerative stem cells may be isolated, eliminating the need for lengthy cell culturing. An easy to follow screen and directional locking mechanisms simplify the user interface.

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