FDA approves first human Stem Cell Clinical Trials

One of America's finest hospitals has been granted FDA approval to conduct first neural clinical Stem Cell trial on glioma brain tumors. Established in 1913, City of Hope neuroscience research teams will take 12 to 20 recurrent high grade glioma patients into their newly developed treatment strategy during coming summer months.
It is estimated over 22,500 US. citizens are diagnosed with malignant brain tumors annually, with just over 50% die each year. Survival rates vary with each type of brain tumor, but those with glioblastoma can expect a life period of around 15 months.
These tumors are highly invasive and ultimately resistant to current methods of treatment such as surgery, radiation and chemotherapy. One significant barrier to treating glioma type tumors is the presence of a blood-brain barrier, that can prevent chemotherapy agents entering the brain and reaching effective concentrations at tumor sites.
The first in-human clinical trial of a neural stem cell-based therapy will be an investigational targeted treatment option to see if eventual treatments develop a platform technology to target multiple agents to brain tumors, as well as other metastatic solid tumors inside and outside of brain.
This novel tumor-selective treatment has potential to overcome many obstacles that limit the success of currently available treatments of malignant tumors and other invasive cancers. Modified neural stem cells are injected during surgery into cavity wall of remaining tumor after tissue has been removed.
Study patients receive daily doses of prodrug 5-FC for one week. Once the 5-FC crosses blood brain barrier, the neural stem cell will convert 5-FC to an active chemotherapy agent 5-FU, at tumor sites in the brain.
As a delivery agent, the stem cells may allow researchers to target concentrated therapies specifically to tumor sites, reducing undesirable side effects to the patient.
Acknowledgment: City of Hope Dept. of Neurosciences, Durate, California. www.cityofhope.org Geoff.