Allogenic organ transplant
A transplant that uses an organ from another person. Because the cells are not one's own, there is a risk of adverse effects from rejection and immunosuppression.
Autologous cells
Cells which are taken directly from the individual to be treated, which can then be re-implanted in that same individual. Use of autologous cells potentially eliminates the risk of rejection triggered by the patient's immune response. Tengion's technology uses only autologous cells.
Bioresorbable materials (or Biomaterials)
Materials which are biologically compatible with the human body and which dissolve completely and harmlessly over time, like sutures, when implanted in the body. Tengion uses these materials to provide a structure for the patient's autologous cells, so that the cells grow in the shape of the required tissue or organ after implantation.
Enterocystoplasty
Enterocystoplasty is a surgical procedure used in adults and children who lack adequate bladder capacity and compliance. During enterocystoplasty, a portion of the patient's stomach or intestine is removed. This tissue is then attached, or grafted, to the patient's bladder to increase the bladder's capacity while maintaining lower pressure.
Enterocystoplasty has certain well documented risks and complications. While effective in increasing bladder compliance and capacity, enterocystoplasty risks and complications significantly impact patient's quality of life and long term outcomes.
While the objective of performing enterocystoplasty is to reduce pressure in the bladder, certain complications can be encountered that may diminish the overall benefit of the treatment. The epithelial lining of the intestine is absorptive and secretive, while urological tissue is water-tight. Placing gastrointestinal tissue in the urological tract can lead to metabolic abnormalities. The absorption of ammonium, chloride and hydrogen ions as well as potassium loss may cause chronic metabolic acidosis. Chronic metabolic acidosis has various outcomes, including compromised growth, particularly in children.
In addition, mucus secreted from the intestinal segment grafted onto the bladder encourages the formation of stones, which may lead to bladder outlet obstruction and recurrent urinary tract infections. Other less frequent complications associated with surgical use of intestinal tissue include perforation and peritonitis. The potential for later development of cancer also exists when intestinal tissue is used in the urinary system.
Tengion Neo-Bladder Augment™ is designed to avoid the acute and chronic risks and complications associated both with the additional intestinal surgery and the use of bowel tissue in place of urinary tissue in current entercystoplasty practice. Tengion Neo-Bladder Augment is designed to increase bladder capacity and decrease bladder pressure while integrating into the patient's body and becoming indistinguishable from the patient's own urological tissues.
The use of Tengion Neo-Bladder to treat patients who would otherwise receive enterocystoplasty has the potential to increase surgical treatment options, improve treatment outcomes and provide patients with an alternative that may improve post treatment quality of life.
Tengion's Neo-Bladder Augment is currently in human clinical trials and will not be commercially available until the completion of human clinical trials and the review and approval of associated marketing applications by the FDA.
Neo-Bladder
See Tengion Neo-Bladder™.
Neo-Kidney
See Tengion Neo-Kidney™.
Neo-organ or neo-tissue
A new organ or new tissue replacing or augmenting a patient’s original native organ or tissue.
Neo-Vessel
See Tengion Neo-Vessel™.
Progenitor cells
Specific healthy cells within a patient's own body (e.g., organ, tissue or blood) that are capable of maturing into specific tissues and regenerating the organ (or tissue). These cells are committed to become a certain cell type (like a bladder cell), and they retain their ability to regenerate.
Radical Cystectomy
Radical Cystectomy is universally accepted as the definitive treatment for muscle invasive bladder cancer. Radical Cystectomy involves complete removal of the bladder. In some cases surrounding tissues such as the lymph nodes (in both men and women), the prostate gland and seminal vesicles (in men), and the uterus and ovaries (in women) are removed as well. The objective of Radical Cystectomy is to prevent cancer progression to other healthy tissues. Native bladder functionality is completely removed from the body, thus normal retention and excretion of urine is not possible.
Current surgical practice to enable the excretion of urine in patients who have undergone a Radical Cystectomy is known as urinary diversion, and either uses a segment of a patient's gastrointestinal tissue to create a pouch or conduit for urine or directly attaches a patient's ureters to an opening in the skin. If a pouch or conduit is created for the patient, the surgical procedure requires the removal of a portion of the patient's intestine. The intestinal tissue is attached to the patient's ureter and to an opening in the patient's skin. The objective of urinary diversion procedures is to provide the patient a means to either directly excrete urine ("non-continent") or to create a mechanism by which the patient may retain an amount of urine to periodically release rather than to continually leak ("continent"). If a patient does not have a pouch or conduit to retain urine, he or she will need to wear an external urine collection device where the ureters meet the skin.
Although urinary diversion allows the patient to excrete urine, significant quality of life issues remain. Patients receiving a pouch or conduit created from intestinal tissue will experience chronic complications. The epithelial lining of the intestine has absorptive and secretive properties which can lead to metabolic abnormalities when it is placed in the urinary system. The absorption of ammonium, chloride and hydrogen ions as well as potassium loss may cause chronic metabolic acidosis. In addition, mucus secreted from the intestinal segment used for the pouch or conduit encourages the formation of stones, which may lead to outlet obstruction and recurrent infection. Other less frequent complications associated with surgical use of intestinal tissue include perforation and peritonitis. The potential for development of cancer also exists when intestinal tissue is used in the urinary system.
In all cases, regardless of intestinal tissue usage, a patient will need to use an external collection device and maintain the surrounding areas and opening in the skin to permit the excretion of urine from the body.
Tengion Neo-Bladder Replacement™ is designed to not only avoid the acute and chronic risks and complications associated both with intestinal surgery and the use of bowel tissue in connection with radical cystectomy, but also to restore bladder functionality for patients who have undergone radical cystectomy. Tengion Neo-Bladder Replacement is designed to develop from a patient's own cells to restore bladder functionality by integrating into the patient's body and becoming indistinguishable from the patient's own urological tissues.
The potential use of Tengion Neo-Bladder Replacement to treat patients who receive a radical cystectomy may increase surgical treatment options, improve treatment outcomes, including the restoration of bladder function, and provide patients with an alternative that may improve post treatment quality of life.
Tengion's Neo-Bladder Replacement™ is currently in preclinical development and is not commercially available.
Regenerative medicine
Regenerative medicine is the application of tissue science, tissue engineering and related biological and engineering principles that restore the structure and function of damaged tissues and organs. This new field encompasses many novel approaches to treatment of disease and restoration of biological function through the following methods:
Collectively, these treatments allow for two substantial advances over current medicine. The first advance is the potential to in vivo (in the living body) regenerate currently irreparably damaged tissues so that they return to full functionality. The second advance is to be able to produce tissues in vitro (in the laboratory) to be used for transplantation purposes when regeneration is not possible. "What truly differentiates regenerative medicine from many current therapies is that it has the potential to provide a cure for failing or impaired tissues and organs." ("2020: A New Vision, A Future for Regenerative Medicine." U.S. Department of Health and Human Services, 2005, p. 12)
Tengion Neo-Bladder™
A combination of cells and biomaterials that, upon implantation in the patient, causes the bladder to regenerate and restores or improves its functionality. The Tengion Neo-Bladder is currently being studied in human clinical trials and is not commercially available.
Tengion Neo-Bladder Augment™
A Tengion Neo-Bladder that is attached to a patient’s native bladder. Upon implantation and regeneration, it is designed to increase bladder capacity and decrease bladder pressure while integrating into the patient's body and becoming indistinguishable from the patient's own urological tissues. The Tengion Neo-Bladder Augment is designed to avoid the acute and chronic risks and complications associated both with the additional intestinal surgery and the use of bowel tissue in place of urinary tissue in current enterocystoplasty practice. The use of Tengion Neo-Bladder Augment to treat patients who would otherwise receive enterocystoplasty has the potential to increase surgical treatment options, improve treatment outcomes and provide patients with an alternative that may improve post treatment quality of life. The Tengion Neo-Bladder Augment is currently being studied in human clinical trials and is not commercially available.
Tengion Neo-Bladder Replacement™
A Tengion Neo-Bladder that replaces a patient’s entire native urinary bladder. Upon implantation and regeneration, it is designed to restore bladder functionality by integrating into the patient's body and becoming indistinguishable from the patient's own urological tissues. The Tengion Neo-Bladder Replacement is designed to not only avoid the acute and chronic risks and complications associated both with intestinal surgery and the use of bowel tissue in connection with radical cystectomy, but also to restore bladder functionality for patients who have undergone radical cystectomy. The potential use of the Tengion Neo-Bladder Replacement to treat patients who receive a radical cystectomy may increase surgical treatment options, improve treatment outcomes, including the restoration of bladder function, and provide patients with an alternative that may improve post treatment quality of life. The Tengion Neo-Bladder Replacement is currently in pre-clinical development and is not commercially available.
Tengion Neo-Kidney™
A combination of cells and biomaterials that, upon implantation in the patient, causes regeneration and restores or improves the functionality of the kidney or one or more of its components. The Tengion Neo-Kidney is in pre-clinical discovery and development and is not commercially available.
Tengion Neo-Vessel™
A combination of cells and biomaterials that, upon implantation in the patient, causes regeneration and recapitulates, restores or improves vessel functionality. The Tengion Neo-Vessel is in pre-clinical discovery and development and is not commercially available.