Tengion begins phase II clinical trial of regenerated human organ (1/16/2007)
Tengion, Inc of East Norriton, PA has announced that it has launched phase II multi-center clinical study for its urinary neo-bladder construct.
The neo-bladder is technology licensed and adapted from research conducted by Dr. Anthony Atala, who in April 2006 announced he was the first person to successfully grow and transplant organs into human recipients.
The study is enrolling 10 pediatric patients with neurogenic bladder secondary to spina bifida. Spina bifida is a birth defect resulting from the incorrect development of the spinal cord that can leave the spinal cord exposed, it often causes problem with control of the bladder. Spina bifida affects approximately one in every 2,000 babies born in the United States.
The neo-bladder constructs for the patients in this study are being developed at the Tengion pilot manufacturing facility using healthy cells taken from a small biopsy of each patient’s failing bladder. Each construct consists of a biodegradable scaffold seeded with urothelial and smooth muscle cells cultured by Tengion scientists from the patient’s healthy progenitor cells.
A progenitor cell, often confused with stem cell, is an early descendant of a stem cell that can only differentiate (become new tissues), but it cannot renew itself anymore.
A surgeon then implants the neo-bladder construct into the patient’s body, where it is designed to harness the body’s inherent regenerative capabilities resulting in an improved bladder that integrates with the patient’s body as the scaffold degrades.
The goal of the study is urodynamic function of the neo-bladder at 1 year after implantation. Data on the safety of the product is also being collected. The trial is expected to complete enrollment during mid-2007.
Tengion is also working on a technique to grow livers and kidneys, but won’t disclose how far they are from having a product ready for human clinical trials.
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Comments:
| 1. |
WILLIE gloyna |
1/17/2007 9:08:50 AM MST |
As a person in need of a liver transplant it's encouraging to see reserch in this area. Keep up the progress!! |
| 2. |
Val Verita |
2/15/2007 6:32:58 PM MST |
Any plans on cloning human testicles yet? I think I may be able to offer some assistance in the matter. A lot of men and young men are aflicted of gonnadis for various reasons and it would be a sin not to go ahead and plan cloning from their own genes. This would be ethical and it would be also legal. I would love a reply from you. Thank you. I can be contacted at valverita@yahoo.com |
| 3. |
Larry Tournay |
3/27/2007 2:33:12 PM MST |
Do you have any plans or do you think it will be possible to use the new bladder to replace one that is dammaged from cancer.
I am a male age 37 with bladder cancer. The tumer has been removed and the doctor is trying BCG treatments to controll it. I have had six treatments and it has removed all the cancer execpt a trace was found where the tumor was removed. The doctor is trying six more. If that does not work I may have to have my bladder removed.
Good luck with your research.
Larry
larrytournay@hotmail.com
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| 4. |
Jaclynn |
4/21/2007 1:43:14 PM MST |
I am looking for a doctor to cloan a bladder for my daughter. She has Cloacal Exstrophy and Spina Bifita
please contact me at:
Crazjacki@yahoo.com
thank you ,
jackie
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