FDA OKs First Human Trial of Neural Stem Cell Therapy

An anonymous reader sends word that the FDA has approved a phase 1 trial for Neuralstem, a company with a patented stem cell procedure targeting ALS (Lou Gehrig's disease) and other spinal conditions. The company's CEO said in a press release, "While this trial aims to primarily establish safety and feasibility data in treating ALS patients, we also hope to be able to measure a slowing down of the ALS degenerative process." Results are expected in 2 years. The trial will involve 12 ALS patients who will receive stem cell injections in the lumbar area of the spinal cord. An information site for the disabled community adds hopefully: "If it makes it through all stages of testing, we will see if doctors are willing to [use] it on subjects that have injuries coming from physical injuries like diving accidents."

Comments

Re:Wonder how this will cost

[Threni]

Kids eat too much anyway - it'll do them good. How much does a sandwich and an apple cost, anyway? You're not going to fund much research for that.

Misleading Title

[DynaSoar]

The first US phase 1 trial, yes. The FDA couldn't have approved the first neural stem cell trial because it was conducted in Sweden by Hakan Widner in 1982 http://www.nytimes.com/1992/11/26/us/success-reported-using-fetal-tissue-to-repair-a-brain.html

George Carillo was the first recipient. He was the first and worst of the 'frozen addicts' covered in J William Langston's "The Case of the Frozen Addicts". His and others' poisoning by MPTP contaminated home made fentanyl resulted in Parkinsonism, which was partially reversed by fetal neural cell grafting http://en.wikipedia.org/wiki/MPTP

Their misfortune and subsequent treatment contributed to our now extensive understanding of Parkinson's and of the dopamine system, understanding that contributed to the success of Drs Arvid Carlsson, Paul Greengard, and Eric R. Kandel, recipients of the 2000 Nobel Prize in Medicine and Physiology. It also contributed to the discovery of endogenous MPTP, and that its conversion to MPP+ in neural mitochondria could be blocked in a majority of cases by trimethylnaphthoquinone, an MAO inhibitor found in tobacco.