Extracorporeal cell-based therapeutic device and delivery system
Inventors
Assignees
Publication Number
US-8048419-B2
Publication Date
2011-11-01
Expiration Date
2027-02-01
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Abstract
Extracorporeal cell-based therapeutic devices and delivery systems are disclosed which provide a method for therapeutic delivery of biologically active molecules produced by living cells in response to a dynamic physiologic environment. Exemplary designs are disclosed. In a first exemplary embodiment the device includes long hollow fibers in which a layer of cells are grown within the intraluminal volume or within a double hollow-filled chamber. In another exemplary embodiment the device includes a wafer or a series of wafers forms a substrate onto which cells are grown. The wafer(s) are then inserted into a device. The devices are intended to be extracorporeal. Disclosed is a device for delivering a pre-selected molecule, for example, a hormone, into a mammal's systemic circulation. The device may also deliver a member of different cell products. The device comprises an anchoring element that can be anchored to an inner wall of an extracorporeal tube for blood. The device also comprises a capsule that is held in place within the extracorporeal tube for blood or fluid by an anchor. The device is adapted to secure viable cells which produce and secrete the pre-selected molecule into blood or fluid passing the capsule. The invention also provides a minimally invasive method for percutaneously introducing into a preselected blood vessel or body cavity the device of the invention.
Core Innovation
The invention provides an extracorporeal cell-based therapeutic device and delivery system for introducing biologically active molecules, such as hormones or other cell products, into a mammal’s systemic circulation or body fluids. The core innovation lies in a device that houses viable cells capable of producing specific therapeutic molecules in response to physiological cues when placed within an extracorporeal blood or fluid circuit, thus enabling direct delivery to the patient without requiring invasive surgical implantation.
The problem addressed by the invention centers on the limitations of prior implantable cell-based drug delivery systems, which require device miniaturization due to anatomical constraints, present challenges for secure and atraumatic anchoring within vessels, and are difficult to retrieve after implantation. The invention also seeks to overcome logistical issues with current devices that demand expensive and time-consuming storage and shipping at body temperature, complicating rapid onsite therapy deployment.
Distinct configurations are disclosed, wherein cells are either grown inside or on hollow fibers made of semipermeable membranes or attached to trabeculated, niobium-coated carbon disks within a capsule. The device includes features such as an anchoring system for securing to an extracorporeal blood or fluid tube, semipermeable barriers to ensure immunoprotection, and materials allowing for the diffusion of therapeutic products while preventing escape of the cells. Methods for cryopreservation and onsite preparation of therapeutic units are also detailed, increasing the system’s flexibility and commercial viability.
Claims Coverage
There are two independent claims that define the inventive features of the disclosed extracorporeal cell-based therapeutic device and cryopreserved composition.
Extracorporeal device containing viable renal cells on a frozen, niobium-coated carbon scaffold
An extracorporeal cell-based therapeutic device that includes: - A housing defining an interior space with viable renal cells disposed inside. - A frozen scaffold made of carbon material coated with niobium, having a trabecular structure placed within the housing. - The viable renal cells are attached to the scaffold.
Cryopreserved composition of renal cells attached to frozen niobium-coated carbon scaffold
A cryopreserved composition comprising: - Renal cells attached to a frozen scaffold. - The scaffold is made of carbon material coated with niobium and has a trabecular structure.
These inventive features provide devices and cryopreserved compositions wherein viable renal cells are housed or attached to specifically structured, niobium-coated carbon scaffolds, enabling effective extracorporeal therapeutic delivery.
Stated Advantages
The extracorporeal device can be more easily removed from the circulation system than an implanted device, simplifying retrieval.
Because the device is extracorporeal, it avoids size constraints imposed by internal anatomy, allowing for larger cell-bearing units and increased delivery rates.
The anchoring system of the extracorporeal device does not require designs to prevent trauma to blood vessels, reducing concerns over tissue damage.
Delivery of therapeutic molecules can be done without invasive surgical procedures.
The invention allows onsite cryopreservation and storage, eliminating the need for shipping and storage at 37°C and enabling rapid clinical deployment.
The semi-permeable membrane provides immunoprotection for the therapeutic cells, preventing immune rejection.
Documented Applications
Therapeutic delivery of molecules, such as hormones (including erythropoietin and insulin), growth factors, anti-coagulants, and immunomodulators, into blood or body fluids via an extracorporeal circuit.
Renal support therapy, including replacement of kidney functions such as filtration, transport, metabolic, and endocrinologic activity, especially in acute renal failure (ARF) or multiple organ failure (MOF).
Treatment of systemic inflammatory response syndrome (SIRS) and sepsis, particularly for improving survival in patients with severe sepsis or septic shock.
Broad potential use in other cell therapies including treatment for neurodegenerative disorders (Parkinson’s, Alzheimer’s), spinal cord injury, heart disease, pancreas disease (diabetes), liver disease, blood disorders, muscle disorders, skin conditions, and bone diseases.
Use with extracorporeal blood circuits such as arteriovenous (AV) or venovenous (VV) lines, and with peritoneal fluid in peritoneal dialysis.
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