Regenerative Medicine

Bench to Bedside Scalability & Regulatory Compliance:  Making Regenerative Medicine a Reality

 

Expedite translation of regenerative applications from bench to commercialization using a non-viral, cGMP-compliant cell engineering platform that provides the necessary performance and scalability while overcoming regulatory hurdles. The MaxCyte delivery platform harnesses the power of primary cells through high performance cell engineering to create cell-based therapies with increased therapeutic potential.

  • Non-viral, inherently safe cell engineering
  • Unmatched primary & stem cell transfection efficiencies
  • High cell viability with minimal cell disturbance
  • Bench to bedside scalability
  • Computer-controlled, closed environment for robust manufacturing
  • Validated platform with a clear regulatory pathway – cGMP compliant and FDA Master File

 

 

Case Study: Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension (PAH) is a progressive and ultimately lethal disease characterized by a persistent elevation in pulmonary arterial pressure due to narrowing of arterioles and loss of pulmonary microvessels. Cell-based therapies offer the potential to repair and regenerate the lung microcirculation.

Endothelial progenitor cells (EPC) have been intensively studied and are felt to have great potential for cardiovascular regenerative applications, however initial animal studies administering unmodified EPCs exhibited insufficient potency to warrant clinical development. MaxCyte’s cell engineering platform has enabled development and clinical translation (PHACeT Clinical Trial) of a stem cell therapy with increased potency in which EPCs are engineered to express endothelial nitric oxide synthase (eNOS-EPCs).

PAH Reversal Upon eNOS-EPC Cell Infusion

 

Rats were administered monocrotaline (MT) to induce PAH. Twenty-one days post MT, rats were infused with either naïve cells or EPCs transfected with eNOS. Right ventricular systolic pressure (RVSP) was measured throughout the 35 day study. Figure adapted from Burrill Stem Cell Report, October 2007.

Enhanced Survival Following Administration of eNOS-EPC Cells

 

 

Rats were administered monocrotaline (MT) to induce PAH. Twenty-one days post MT, rats were infused with either naïve cells or EPCs transfected with eNOS. Kaplan-Meier analysis demonstrated that eNOS- EPC treatment lead to enhanced survival as compared with the control group (no cell infusion). Figure adapted from Circ Res, 96:442-450, 2005.

Key Scientific Publications

 

  • Endothelial NO-Synthase Gene-Enhanced Progenitor Cell Therapy for Pulmonary Arterial Hypertension: The PHACeT Trial. Circ Res, 117:645-654, 2015.
  • Modifying Stem Cells for Clinical Regenerative Applications: A Practical Approach to a Fundamental Problem in Translational Research. Burrill Stem Cell Report, October 2007.
  • Rescue of Monocrotaline-Induced Pulmonary Arterial Hypertension Using Bone Marrow–Derived Endothelial-Like Progenitor Cells Efficacy of Combined Cell and eNOS Gene Therapy in Established Disease. Circ Res, 96:442-450, 2005.

 

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