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Posted on Jan 15, 2007, 5 a.m.
By Bill Freeman
A UK company is applying for permission to transplant stem cells made from human foetal tissue into the brains of stroke patients. Guildford-based ReNeuron has told the BBC it has convincing lab evidence that the cells could potentially regenerate brain cells damaged by a stroke. It has applied to the US Food and Drug Administration to carry out human trials on 12 stroke patients. However, opponents have said it is a "sick proposal". The ReNeuron team have successfully extracted stem cells from the developing brain area of a 12 week old aborted foetus.
A UK company is applying for permission to transplant stem cells made from human foetal tissue into the brains of stroke patients.
Guildford-based ReNeuron has told the BBC it has convincing lab evidence that the cells could potentially regenerate brain cells damaged by a stroke.
It has applied to the US Food and Drug Administration to carry out human trials on 12 stroke patients.
However, opponents have said it is a "sick proposal".
The ReNeuron team have successfully extracted stem cells from the developing brain area of a 12 week old aborted foetus.
These cells have begun to specialise into brain cells and have the ability to rapidly generate brain tissue.
According to Dr Eric Miljan, Reneuron's head of stem cell discovery, when the foetal stem cells were injected into the brains of rats in which a stroke had been induced their movement recovered.
Tests showed that blood flow and brain activity were restored in the damaged area.
Dr Miljan said: "We're very excited. There have been a battery of tests. There have been a series of animal safety experiments. And they work.
" We feel that we are ready to go into patient trials."
The company is to submit its research results to the FDA, and if the human trial is approved it could begin early next year.
Safety concerns
But the regulators will want to be satisfied that the trials will be safe and hold out a realistic chance of doing some good.
In particular they will want to look closely at a crucial part of the treatment which involves genetically modifying the foetal brain cells.
The researchers incorporate a gene called c-myc which is associated with normal cell division.
However, when there are abnormalities with cells the gene can be involved in the uncontrollable replication of cells and lead to cancer.
ReNeuron say they have safely harnessed this property by modifying this gene to make its action fully controllable.
They add the modified version of the gene so that it can cause a small number of foetal stem cells to multiply when a chemical is added. In effect, this provides a biochemical way of photocopying the cells.
The replication stops once the chemical is taken away. Ethics case Michael Hunt, ReNeuron's CEO, said: "We have proven with reams of experimental data that the system is fully controllable.
