Navigation Links
FDA approves first human neural stem cell clinical trial to treat brain tumors
Date:6/8/2010

DUARTE, Calif. -- City of Hope researchers received approval from the U.S. Food and Drug Administration (FDA) to conduct the first-in-human study of a neural stem cell-based therapy targeting recurrent high-grade gliomas, the most aggressive type of brain tumor. Karen S. Aboody, M.D., associate professor in City of Hope's Department of Neurosciences, leads the research team that developed this treatment strategy. Jana Portnow, M.D., assistant professor and assistant director of the Brain Tumor Program at City of Hope, is the principal investigator for the clinical trial.

An estimated 22,500 Americans are diagnosed with malignant primary brain tumors annually, and more than 12,900 die each year from the disease. While survival rates vary with the type of brain tumor, median survival for glioblastoma, the most common type of glioma in adults, is only about 15 months. These tumors are highly invasive and ultimately resistant to current methods of treatment such as surgery, radiation and chemotherapy. One significant obstacle to curing brain tumors is the presence of the blood-brain barrier which can prevent chemotherapy agents from entering into the brain and reaching effective concentrations at tumor sites.

"This first-in-human clinical trial of a neural stem cell-based therapy that we developed at City of Hope is an investigational, targeted treatment option for recurrent high-grade glioma patients," said Aboody. "Furthermore, we envision the eventual development of neural stem cells as a platform technology for targeting multiple therapeutic agents to brain tumors, as well as other metastatic solid tumors inside and outside the brain."

Aboody and her colleagues were the first to demonstrate in 2000 the inherent propensity of neural stem cells to home in on invasive tumor cells, also known as tropism, even migrating from the opposite side of the brain or across the blood-brain barrier. Aboody's research team has since harnessed the tumor-tropism of neural stem cells to deliver therapeutic agents to invasive tumor sites, which they demonstrated in laboratory testing. The therapy uses a genetically modified human neural stem cell line, generated by Seung U. Kim, M.D., Ph.D., professor in the Division of Neurology at the University of British Columbia, to deliver a prodrug-activating enzyme (cytosine deaminase) to brain tumor sites. This enzyme converts a relatively nontoxic prodrug (5-Fluorocytosine, 5-FC), which is delivered systemically, into an active cancer-fighting chemotherapeutic (5-Fluorouracil, 5-FU). In effect, this stem cell-mediated strategy achieves production of the chemotherapeutic drug only in the area of the tumor. This investigational treatment concentrates anticancer compounds at tumor sites while minimizing exposure of surrounding healthy tissue.

"This novel tumor-selective treatment has the potential to overcome many obstacles that limit the success of currently available treatments for malignant brain tumors and other invasive cancers," said Aboody. "Using neural stem cells as delivery vehicles for therapy may allow us to target concentrated therapeutics specifically to tumor sites while reducing the undesirable side effects of current chemotherapy regimens, including toxicity to normally dividing bone marrow, gastrointestinal tract, skin and hair cells."

The clinical trial will begin accepting patients this summer, with the goal of enrolling 12 to 20 patients with recurrent high-grade gliomas. The modified neural stem cells will be injected during surgery into the wall of the cavity remaining after tumor tissue has been removed. Study patients then receive daily doses of the prodrug 5-FC for one week. Based on Aboody's laboratory findings, once the 5-FC crosses the blood-brain barrier, the neural stem cells will convert the 5-FC to the active chemotherapy agent, 5-FU, at tumor sites in the brain. The phase I safety trial will assess the maximum tolerated dose of the therapy, and is supported by a grant from the National Cancer Institute, part of the National Institutes of Health.


'/>"/>

Contact: Shawn Le
sle@coh.org
800-888-5323
City of Hope
Source:Eurekalert

Related medicine news :

1. FDA Approves First Additive Solution for Platelet Storage Up to 5 Days
2. State Approves Certificate of Need for New PeaceHealth San Juan Island Hospital
3. U.S. Approves New Stem Cell Lines for Publicly Funded Research
4. State Approves Plans For Kidney Transplants At Advocate Christ Medical Center
5. Medizone International, Inc. Approves Repurchase of Global Marketing Rights
6. A Christmas Gift for Eric: Senate Approves Health Care Bill in Historic Christmas Eve Vote
7. Kaiser Permanente Approves $170 Million in Community Benefit Grants in 2009
8. The American Association of Anatomists approves guidelines for body donation programs
9. Golden Meditech Shareholders Approves of Name Change
10. New Jersey Approves Initiative to Expand the Number of Wound Care Certified Professionals
11. Congress Approves Bill Curbing Internet Tobacco Sales in Victory for Kids and Taxpayers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... ... February 12, 2016 , ... Nearly every ... promote eye health. These articles generally list between five and 15 foods that ... Kleyne endorses every one of these lists and believes that nutritious eye healthy ...
(Date:2/12/2016)... ... February 12, 2016 , ... US Sport Camps is pleased to announce the ... in Norwalk, serves as the host site and directing the camps is PGA Professional ... had successful camps in recent years around Des Moines and are fortunate to have ...
(Date:2/12/2016)... ... 12, 2016 , ... The Central Coast Autism Spectrum Center (CCASC) invites teens ages 11-18 to ... of fun for teens with and without special needs to gather in a safe and ... event. The dance will take place on Saturday, Feb. 13 from 7 to 9:30 p.m. ...
(Date:2/12/2016)... ... 12, 2016 , ... Basketball is a game for everyone, not just those ... series, sign language translation is featured in the top right of the screen. Every ... lessons has a sign language translator to teach kids the game and how to ...
(Date:2/12/2016)... ... February 12, 2016 , ... Dignity Health named Dr. ... Emergency Room –Mesa. The new facility is licensed under Dignity Health Arizona ... Bingham is an excellent leader and will ensure our new freestanding emergency room delivers ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... Calif., Feb. 11, 2016 PRO-DEX, INC. (NasdaqCM: PDEX) ... ended December 31, 2015. The Company also filed its Quarterly ... year 2016 with the Securities and Exchange Commission today. ... 31, 2015 --> --> ... increased $2.6 million, or 95%, to $5.4 million from $2.8 ...
(Date:2/11/2016)... DUNKIRK, N.Y. , Feb. 11, 2016  Governor ... Athenex that will create 1,400 jobs throughout ... by a partnership with the SUNY Polytechnic Institute, includes ... the Conventus Building in Buffalo , ... square foot manufacturing facility in Dunkirk ...
(Date:2/11/2016)... , Feb. 11, 2016  MiMedx Group, Inc. ... utilizing human amniotic membrane and other birth tissues, human ... to develop and market advanced products and therapies, announced ... Markets, 2016 Global Healthcare Conference in New ... and CEO, Michael J. Senken , Chief Financial ...
Breaking Medicine Technology: