• Welcome, Guest. Please login or register.
    May 30, 2020, 07:26:48 AM

  • Login with username, password and session length

Sajid's dove

Tell everyone they can now find this site by typing this into their browser:

thalpal.com

Click to visit us on Facebook


If you have any problems registering or signing in, please send an email to: andythalpal@yahoo.com
Please do not send questions about thalassemia to this address.


Administrators
Andy
Danielle

Thalassemia Patients and Friends and thalpal © A. Battaglia 2019





55292 Posts in 5909 Topics by 6204 Members
Latest Member: pareshdas1985

Forum Tip: 
You can change your member name in your profile, under "Account Related Settings," so you don't have to re-register to change it.
« previous next »
Pages: 1 Go Down Print
Author Topic: StemEx(R), A Gamida Cell-TEVA Joint Venture Cell Therapy Product,  (Read 3206 times)
nice friend
Thalassemia Major
Greeter
Supreme Member
*
Offline Offline

Location: Faisalabad, Pakistan.

Gender: Male
Posts: 2834


If I Can, Why Not You??... If I Can U TOO !!!...


« on: March 17, 2009, 09:21:39 AM »

StemEx(R), A Gamida Cell-TEVA Joint Venture Cell Therapy Product, Receives Orphan Medicinal Product Designation In The European Union


http://www.stemexstudy.com/index.html
Quote
What is the ExCell study?
ExCell is a clinical trial studying StemEx® as an alternative transplantation option for adolescents and adults with leukemia, lymphoma and other high risk hematological malignancies, who are unable to find  a matched, related bone marrow donor.

The ExCell study is sponsored by the Gamida Cell-Teva Joint Venture. The JV is committed to advancing the clinical development of StemEx® and improving the treatment of adolescents and adults with hematological malignancies. 

http://www.gamida-cell.com/stemex.asp
Quote
Hematopoeitic Stem Cell Transplantations
Bone marrow transplantation is a life saving treatment for many types of leukemia and lymphoma. However, matched bone marrow donors are identified for only approximately 30% of the patients in need of a bone marrow transplant. The other 70% are not as fortunate and cannot find a match. The problem is even more acute for minority population patients, whose chances of finding a matched, unrelated marrow donor are extremely small.

Research shows that cells in umbilical cord blood have been used successfully to overcome the challenge of finding a matched donor for patients. Umbilical cord blood stem cells offer a viable therapeutic option for leukemia and lymphoma patients without an appropriate matched donor. Umbilical cord blood presents two important advantages: it is readily available and has a lower histocompatibility (matching) requirement. Therefore almost all patients will be able to identify a matched cord blood donor.

However, the limited cell dose found in cord blood units poses a significant challenge: the need for a large enough supply of healthy stem cells to stimulate the regeneration of bone marrow or the tissue of a particular organ and to achieve successful engraftment in adult and adolescent patients. Gamida Cell’s technology expands populations of cord blood stem cells with limited differentiation to create a therapeutic dose to treat such patients.

Gamida Cell's Phase III Product: StemEx® for Leukemia and Lymphoma
Gamida Cell's phase III product, StemEx, offers a novel solution for patients with various critical hematological diseases such as leukemia and lymphoma who cannot find a matched bone marrow donor and are in need of a transplant. StemEx is composed of ex vivo expanded cord blood stem/progenitor cells which are transplanted with non-expanded cells from the same unit. StemEx production utilizes modification of the level of free copper in the cells, to allow large-scale, ex vivo self-renewal of stem/progenitor cells, with limited differentiation, in a reasonably short time. The StemEx product and its underlying technology are covered by two broad US patents: No. 6,887,704 and No. 09/463,320, and numerous other related patents granted worldwide.

Partnership with Teva Pharmaceuticals
StemEx is being developed by the Gamida-Cell-Teva Joint Venture which owns the commercialization and marketing rights for the product. The JV is now enrolling for the ExCell trial, multi-center, multi-national, historical cohort controlled, pivotal phase III study to evaluate efficacy and safety of transplantation of StemEx in subjects with hematologic malignancies following myeloablative therapy (http://stemexstudy.com/). The clinical protocol received a Special Protocol Assessment with the FDA, in October 2006. The same agency granted StemEx orphan drug designation in March 2005.

Andy and all others : my question is ,  Is this study have potential to cure Thalassemia Huh?....

Best Regards
Take Care
Umair
« Last Edit: March 17, 2009, 09:48:12 AM by nice friend » Logged

Sometimes , God breaks our spirit to save our soul.
Sometimes , He breaks our heart to make us whole.
Sometimes , He sends us pain so we can be stronger.
Sometimes , He sends us failure so we can be humble.
Sometimes , He sends us illness so we can take better care of our selves.
Sometimes , He takes everything away from us so we can learn the value of everything we have.

===========
Umair
Pages: 1 Go Up Print 
« previous next »
Jump to:  

Powered by MySQL Powered by PHP Powered by SMF 1.1.21 | SMF © 2015, Simple Machines Valid XHTML 1.0! Valid CSS!