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HART & Mayo Clinic sign a joint development agreement to work together on advanced solutions for better patient care.

Automated Decellularization Procedure for Lungs published by scientists at the University of Minnesota suggests automatic decell program to be superior in performance and reproducibility than manual methods.

ORCA Solid Organ Bioreactors were recently equipped with additional fittings and access ports to increase the flexibility of the systems.

New Large Animal Hollow Organ Bioreactor has been introduced to expand the type and size of hollow organs that can be studied.

Long Term Large Animal Trachea Studies Continue

Long-term trachea studies in large animals continue at HART. Scientists are combining 2nd generation electrospun tracheas and surgical experience to advance the viability and long term sustainability of implants. The surgeon was pleased with the initial bronchoscopy results after implantation.

Proprietary manufacturing protocols have been developed to maximize structural integrity without sacrificing the flexibility needed. Critical parameters which include fiber density and pore size have been studied and optimized which eliminate delamination from being a major concern.

The number of cells required for seeding in many synthetic scaffolds is dramatically reduced when combined with a new generation large animal hollow organ bioreactor. Cell growth on the new scaffold has met desired density and viability targets. The microcomposite structure of the scaffold has been further optimized and recent animal data indicates that integration of the scaffold with surrounding tissues is possible. New Mode of Action data on the microfiber scaffold has been generated that has not been possible in the past, thanks to a new in vivo animal model.

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HART has signed a joint development agreement with Mayo Clinic with the intent of developing and improving regenerative medicine treatments for severe diseases.

David Green, CEO of HART, stated "This new collaboration is an important development for our company. It indicates significant progress in HART’s strategy of moving forward with major American and European medical institutions to bring new products to the clinic. We are very excited to expand our relationship with Mayo Clinic, one of the world’s great medical institutions, and to work with them on co-developing regenerative medicine solutions for the trachea, esophagus and heart valve and bringing those solutions to patients at Mayo Clinic and worldwide."

Dennis Wigle, M.D., Ph.D., thoracic surgery, Mayo Clinic, stated, "Regenerative medicine is a focus area for Mayo Clinic and will be a vital component of medical and surgical practice in the coming years. Through regenerative medicine, it is possible to actually heal diseased, injured or congenitally defective tissues and organs that today are beyond repair." Mayo Clinic and HART have collaborated for the past two years in Mayo Clinic's program to develop a synthetic human heart valve. The relationship has grown between the two groups and this collaboration is designed to foster work on additional organs such as the airway and the esophagus.

Patented inventions made during the course of the collaboration may be licensed by HART and HART will pay royalties to Mayo Clinic.

Dr. Wigle added, "This relationship is important because the new directions for medicine are so complex that they require cross-collaboration to bring the benefits to patients. HART brings a unique set of skills in physiology, scaffolding and bioreactors as well as translation from invention to clinical use that we find extremely valuable in moving our regenerative medicine program forward."

By working together, HART and Mayo Clinic intend to turn promising laboratory discoveries into proven treatments and make them available to patients. HART's expertise in the design and construction of regenerative medicine-related devices will be coupled with Mayo’s commitment to improving patient outcomes.

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Automated Decellularization of Intact, Human Sized Lungs for Tissue Engineering

Price Andrew P., Godin Lindsay M., Domek Alex, Cotter Trevor, D’Cunha Jonathan, Taylor Doris, Panoskaltsis-Mortari Angela. Tissue Engineering Part C: Methods—Not available—ahead of print doi: 10.1089/ten.tec.2013.0756. June 16,2014

Abstract

We developed an automated system that can be used to decellularize whole human-sized organs and have shown lung as an example. Lungs from 20 to 30 kg pigs were excised en bloc with the trachea and decellularized with our established protocol of deionized water, deter- gents, sodium chloride, and porcine pancreatic DNase. A software program was written to control a valve manifold assembly that we built for selection and timing of decellularization fluid perfusion through the airway and the vasculature. This system was interfaced with a prototypic bioreactor chamber that was connected to another program, from a commercial source, which controlled the volume and flow pressure of fluids. Lung matrix that was decellularized by the automated method was compared to a manual method previously used by us and others. Automation resulted in more consistent acellular matrix preparations as demonstrated by measuring levels of DNA, hydroxyproline (collagen), elastin, laminin, and glycosaminoglycans. It also proved highly beneficial in saving time as the decellularization procedure was reduced from days down to just 24 h. Developing a rapid, controllable, automated system for production of reproducible matrices in a closed system is a major step forward in whole-organ tissue engineering.

Scanning electron microscopy images of control (upper row), automated (middle row), and manually decellularized (lower row) porcine lung. Samples were prepared and imaged at the University of Minnesota Imaging Facility as described in the text. Images show that lungs decellularized with the ADS maintain good structural integrity, whereas those decellularized manually have areas that appear to have been damaged. Representative images from three lungs/ group shown. Magnification 700.

Decellularization system setup. The entirety of the decellularization system setup shows the different carboys holding the solutions needed for decellularization (water, Triton X, sodium deoxycholate, NaCl, DNase, and phosphate-buffered saline [PBS]), computer control of the valve system, pumps, and the decellularization chamber that has multiple inputs and outputs for tubing, air bubble traps, and pressure transducers.


New Large Animal Hollow Organ Bioreactor

The Hollow Organ Bioreactors represent the next generation in the tools available to the regenerative medicine scientist in research using synthetic and natural hollow organs. Protocols may be developed and implemented allowing consistent decellularization of natural organs. Physiological conditions may be mimicked to allow optimum recellularization of natural and synthetic scaffolds.

Some of the characteristics of the unit include:

Small to large animal organs are easily accommodated using two chamber sizes and a series of organ holders.

Clear Housing made of polycarbonate to allow easy viewing and recording of progress using microscope cameras.

Sterilizing the unit is easily performed in the laboratory by standard autoclaving techniques as well as EtO and plasma sterilization procedures.

Multiple flow paths are available allowing individual media to be used in the intraluminal and extraluminal flow paths.

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The ORCA Controller Provides the Most Flexible Bioreactor for Regenerative Medicine Research

The ORCA Controller provides the most flexible platform available. Control systems allow the implementation of challenging protocols while protecting the organ. Documentation of each step performed is provided as well as still photos and video that can be archived and compared to previous organs.

Some of the key features include:

  • Mimicking of physiological conditions can be accomplished by use of pressure and flow programming. Flow programming includes constant or ramping of flow or pressure as well as pulsatile and oscillatory modes.
  • Remote Access is available allowing access from off site locations with devices such as tablets or an IPhone.
  • Advanced Analytics through microscope cameras and multiple sensors provide real time viewing as well as archiving of photos and video. A complete audit trail is automatically developed and stored for each run including flow, temperature and pressure readings.
  • Graphical Representation of key parameters is available to facilitate reviews.
  • Method and Protocol Development is facilitated as the ORCA controller stores all parameters of even the most complex protocols. The programs can be retrieved for comparison or modification.
  • Central Control of all key system components and sensors through an easy to understand dashboard.

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