Exclusive License

CardioCell has an exclusive, worldwide license for the manufacture and use of ischemia-tolerant mesenchymal stem cells.  The company’s license spans the entire cardiovascular field.  Indications of key interest to the company include:

  • Heart Failure
  • Acute Myocardial Infarction
  • Acute Coronary Syndrome
  • Peripheral Artery Disease
  • Hypertension
  • Coronary Artery Disease
  • Arrhythmia
  • Atherosclerosis
  • Carotid Artery Disease
  • Cardiomegaly
  • Congenital Heart Disease
  • Endocarditis
  • Mitral Valve Prolapse
  • Valvular Heart Disease

CardioCell’s license includes full rights to clinical and pre-clinical protocols and results that have been generated by CardioCell’s licensor.

The CardioCell Intellectual Property Estate

CardioCell’s intellectual property leverages its license to achieve three tiers of protection:

  • Tier 1:  Trade Secret itMSC Manufacturing Technology
  • Tier 2:  Patent Protection for the Use of Trade Secret itMSCs in Active Therapeutic Programs
  • Tier 3:  Patent Protection for the Use of Trade Secret itMSCs in Therapeutic Programs Under Development

Tier 1 Assets – Trade Secret Protection

CardioCell’s license includes trade secret protection surrounding itMSCs.  The company’s trade secrets cover the protocols for the manufacture, preparation for administration and therapeutic use of itMSCs in the treatment of cardiovascular disorders.  CardioCell’s trade secret protocols for manufacture produce itMSCs having unmatched scalability and therapeutic potential.  Included in the company’s trade secrets is the manufacture and use of itMSC factors in the cardiovascular space.

Trade secret protection provides CardioCell with a strong competitive edge in the cardiovascular space.  The company’s trade secrets remain valid and enforceable without regard to the limitations imposed by patent term life.  This is a particular advantage given that much of a patent’s life might be consumed by the period it takes for a patented technology to achieve regulatory approval.

In addition, trade secret protection allows CardioCell to avoid the uncertainty surrounding the patent protection of biologics.  Recent court decisions have called into question whether isolated biologics, such as stem cells, qualify as patentable subject matter.  CardioCell’s trade secrets bridge the gap that threatens patent exclusivity for the protection of stem cells.

Tier 2 Assets – Patent Protection for Active Therapeutic Programs

CardioCell is engaged in domestic and foreign patent protection for the use of its trade secret itMSCs in treating cardiovascular conditions.  The company’s portfolio of key patents and patent applications are directed to the treatment of:

  • Heart Failure
  • Acute Myocardial Infarction
  • Acute Coronary Syndrome
  • Peripheral Artery Disease

The company’s portfolio of pending applications is supported by strong clinical data in the treatment of cardiovascular disorders.

Tier 3 Assets – Patent Protection for Therapeutic Programs in Development

Included in CardioCell’s exclusive license is patent protection of genetically modified mesenchymal stem cells.  U.S. Patent No. 9,080,184 covers G-CSF-transfected mesenchymal stem cells and methods for their use and manufacture.  The patented G-CSF transfected mesenchymal stem cells can be produced with CardioCell’s trade secret itMSCs.

G-CSF, or granulocyte colony stimulating factor, is a growth factor that stimulates the bone marrow to produce and release stem cells into the bloodstream.  As stem cells are believed to have paracrine effects that involve the release of therapeutic growth factors, CardioCell is exploring the use of G-CSF-transfected mesenchymal stem cells to increase a patient’s endogenous stem cells in the treatment of cardiovascular conditions.