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.
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.
Tengion Neo-Kidney Augment™ 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 Augment™ is in pre-clinical discovery and development and is not commercially available.
Neo-organ or neo-tissue
A new organ or new tissue replacing or augmenting a patient’s original native organ or tissue.
A combination of cells and biomaterials that, upon implantation in the patient, causes regeneration and recapitulates physiologically functional tissue with a three-dimensional structure that diverts urine from the ureters to a removable, disposable bag, or ostomy bag, outside the body after removal of the bladder. The Tengion Neo-Urinary Conduit™ is in clinical development.
A combination of cells and biomaterials that, upon implantation in the patient, causes regenertion and recapitulates, restores or improves vessel functionality. The Tengion Neo-Vessel Replace-ment™ is in pre-clinical discovery and development and is not commercially available.
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 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 gastroin-testinal 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 re-tain 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.
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)