Firm to launch pioneering stem cell trial

Firm to launch pioneering stem cell trial

uk.reuters.com

A British biotechnology company, working with a team of doctors in Scotland, is to launch a pioneering clinical trial to assess whether stem cell therapy can help patients left disabled by stroke.

ReNeuron Group said on Sunday it had received approval from the UK Medicines and Healthcare Products Regulatory Agency to commence the clinical trial using its foetal stem cells.

(visit the link for the full news article)


Related News Links:
news.bbc.co.uk
www.telegraph.co.uk

I understand that this is a very emotional issue on both sides. I personally have no objections to this kind of research but I do respect the opinion of those who believe otherwise.

I have seen the ravages of Alzheimer's and other diseases that could potentially be cured via stem cells and I could not in good faith deny anyone such treatment should it be available and effective.

Europe is going to be the centre in stem cells and regenerative medicine and that is very exciting
Dr John Sinden
Reneuron

The stem cells will be taken from aborted foetal tissue

This company has previously applied to the FDA for the same clinical trials and was rejected.

These first clinical trials are mostly to determine the safety to patients of the procedure.

(The BBC link includes two video reports)




uk.reuters.com
(visit the link for the full news article)






[edit on 19 Jan 2009 by schrodingers dog]

Framing the debate:

However, the use of an aborted human foetus to create the stem cells will disturb campaign groups who have opposed the use of embryos in this kind of medical research.

When Reneuron first announced that they would apply to the FDA for clinical trials the Society for the Unborn Child described the proposal as "sick".

A spokeperson said: "It involves cannibalising an unborn child.

"It is unethical in every way - killing one member of the human race to help another.
We are totally opposed to this."

In response, Dr Sinden said: "We have only taken one donation of tissue to make this product.

"We have a technology that is able to scale up an individual cell into all of the cells that are required to treat thousands of patients.

We think this is a major plus in the technology we have and really negates the ethical concerns about the original use of foetal tissue.

"It would be ethically wrong to deny treatment."

bbc.co.uk

One last bit of information:

The controversial treatment involves taking stem cells from an aborted foetus and injecting them into the brain of stroke victims. It is hoped the cells, which can renew themselves, will regenerate areas damaged by stroke, and increase patients' movements and mental abilities.

If the trials are successful, they could replicate the achievements of scientists in Spain who in November last year announced the world's first tissue-engineered whole organ transplant using a windpipe made with the patient's own stem cells.

telegraph.co.uk

Thanks for the update on this subject SD...I truly look forward to the day that this therapy becomes mainstream...

Unlike you, I find the Right's argument against the use of Embryonic Stem Cells from an ABORTED fetus to be selfish and quite antediluvian...

For more on this see below...

reply to post by chapter29


As mentioned in my OP I tend to agree with you.

I want to be mindful and respectful of others' opinions on this issue so as to foster a thoughtful discussion.

But you are right, as long as no one is actually aborting fetuses for the purpose of "farming" stem cells, there is imo no valid reason to deny suffering patients this treatment.

reply to post by schrodingers dog

I want to be mindful and respectful of others' opinions on this issue so as to foster a thoughtful discussion.

I know this SD, as demonstrated by many of your other posts...




I on the other hand don't mind being the $hit starter...so, I picked up the flame thrower and took the safety off - ready, willing and waiting...

The statement below by a pro-life group responding to the news is precisely why so many people have such a hard time with pro-lifers on this issue.

The scientists will use cells from an unborn child killed in a 12-week abortion to conduct their experiments.

(emphasis mine)

lifenews.com

Why the lies?
No one, to my knowledge, has ever had an abortion to provide scientists with stem cells.
Or do they have evidence that abortions are being performed with the specific intention to harvest stem cells?

reply to post by schrodingers dog


I have to agree with you here. The company isn't actively trying to get women to abort children and then use the fetuses, they are using already aborted fetuses to perform the research.

I do understand the pro-life mentality of abortion being inheritly wrong (I went to Catholic school), but from my point of view the company does the "unborn child" a service. Instead of being discarded as biohazardous waste, the fetus/embryo will now contribute to healing someone affected by a crippling condition.

In a way, it's morbidly poetic.

Hopefully, research like this will eventually lead science a way to create/harvest stem cells without using embryos, so the whole issue will become moot.

I often wonder why anti-abortionists are so hypocritical.

They contend that stem cell research is wrong because it comes from a “murdered” embryo, yet they have no problem with organs being harvested for transplant from dead infants. They don’t care how an infant died, and even if they were murdered, the organs would be used without issue. Why not object to ALL organ transplants of any human who was “killed”, including adults killed by a drunk driver, a bullet, medical malpractice. . . ?

When Reneuron first announced that they would apply to the FDA for clinical trials the Society for the Unborn Child described the proposal as "sick".

A spokeperson said: "It involves cannibalising an unborn child. "It is unethical in every way - killing one member of the human race to help another. We are totally opposed to this."

In response, Dr Sinden said: "We have only taken one donation of tissue to make this product.

The first thing I thought of was the questions of autonomy that might arise from the "donation" of "clinical trials(i.e. fetuses)"; because wouldn't the mother have to sign away the fetus as a "donar" and if the fetus was dubbed "donar" than there would be a paradox of not just being tissues would be raised. ?

I guess I don't know how that works. maybe it is just a matter of semantics and my brain just can't wrap around the idea of a fetus just being "tissues."

My grandfather has had many strokes and the idea of helping him is wonderful but... I don't know... it really is a tricky subject.

Stem cells donated from umbilical cord and materials is one thing but the whole fetus another. I am assuming that actual brain matter cells would have to be used in the brain and so on. People just don't want to imagine picking apart of a baby/fetus. I may be wrong about this please correct me if I'm wrong.

Wow... really tough subject.


edited to add that I personally have never really come to terms over my thoughts on abortion except to say I believe in a woman's right to choose

[edit on 20-1-2009 by anyone]

reply to post by anyone


The details of the clinical trial are described here: ReNeuron

reply to post by schrodingers dog


Thanks for the link but the paper doesn't get into the details I was looking for so I checked out wiki and posted below a few links that maybe people might want to peruse. I do think that it is a very interesting subject.

stem cell wiki

embryonic stem cell wiki

edited to add the following link which may have been what I was thinking. ?

progenitor cell wiki

[edit on 20-1-2009 by anyone]

reply to post by anyone


Thank you for the helpful links.

I've been digging around the ReNeuron website to find a more comprehensive description of the clinical trial.

ReN001 for stroke

A stroke occurs when blood flow leading to, or in, the brain is blocked (ischaemic stroke) or a blood vessel in the brain ruptures (haemorrhagic stroke), which can result in damage to the nerve cells in the brain and a loss of bodily functions. Stroke is the single largest cause of adult disability in the developed world.Over 150,000 people suffer a stroke each year in the UK, and over 700,000 people in the US. Approximately 80% of these strokes are ischaemic in nature. Our ReN001 stem cell therapy seeks initially to treat those patients who have suffered an ischaemic stroke and have been left disabled by it. These patients constitute approximately one half of stroke survivors.

The annual health and social costs of caring for disabled stroke patients is estimated to be in excess of £5 billion in the UK, with stroke patients occupying 25 per cent of long term hospital beds. In the US, the annual direct and indirect costs of stroke are estimated to be in excess of US$50 billion. The type of stroke treatment a patient should receive depends on the stage of disease. Generally there are three treatment stages of stroke:

Prevention - treatments to prevent a first or recurrent stroke are based on treating associated risk factors, e.g. high cholesterol, smoking and diabetes;

Treatment immediately after the stroke; acute-phase stroke treatments attempt to arrest a stroke whilst it is happening by dissolving the blood clot that has caused the infarct; and

Post stroke rehabilitation - the aim of post stroke rehabilitation is to improve both functional and cognitive recovery in the patient some weeks or months after the stroke event.

It is this third treatment stage that our ReN001 stem cell therapy will address in initial clinical trials. A number of treatments exist or are in development to treat stroke patients in the acute phase. However, there are currently no therapies available for patients who have a stable and fixed neurological deficit following a stroke. Our ReN001 cell therapy for stroke consists of a neural cell line, designated CTX, which has been generated using our proprietary cell expansion and cell selection technologies and then taken through a full manufacturing scale-up and quality-testing process. As such, ReN001 is a standardised, clinical and commercial-grade cell therapy product capable of treating all eligible patients presenting.

ReN001 has been shown to reverse the functional deficits associated with stroke disability when administered several weeks after the stroke event in relevant pre-clinical models. Extensive pre-clinical testing also indicates that the therapy is safe, with the ReN001 cells eventually cleared from the body with no adverse safety effects arising. We have filed for approval to commence initial clinical studies with ReN001, targeting either the US, UK or Australia as the territory in which the initial clinical study will be undertaken.

The aim of the initial Phase I clinical trial with ReN001, if approved, is to evaluate the safety of the implantation technique and to establish the side effect profile associated with the implantation of ReN001 stem cells in patients who have suffered an ischaemic stroke.Additionally, we aim to collect preliminary efficacy data by evaluating any improvement reported in stroke-specific assessments that will be made regarding neurological function on an on-going basis throughout the study.

The actual surgical technique that will be used in the ReN001 clinical trials known as stereotactic injection, is a well-established and relatively straightforward procedure in neurosurgery. With the aid of a stereotactic co-ordinate frame in place around the patient's head, the neurosurgeon will use a special cannula to implant the ReN001 cells directly into the target brain region through a single, small craniostomy burr hole in the skull. The implantation procedure takes between one and two hours, depending on the cell dose administered. The patient will remain in the hospital overnight and will normally be discharged the morning after surgery.

Patients in the proposed Phase I trial will be followed up over an initial one year period to evaluate the safety of the ReN001 therapy and any potential improvement in neurological function. These clinical assessments will involve scoring against several stroke-specific scales as well as a battery of other tests designed to evaluate both motor and cognitive function over time. Ongoing monitoring of the patients will also continue in the longer term following the one year end-point.

ReNeuron

I apologize for the long quote.

Well I hope I didn't derail your thread. I was hoping to come back to find more opinions and info. on this.

I am very curious about it all so I will bump it with this link.

I found the content very interesting. What do you think?