Fat-derived stem cells safe and feasible for SPMS, clinical trial

I have secondary progressive multiple sclerosis (SPMS) and am delighted with any advance in treating that form of the disease.

This week, I am pleased that a clinical trial shows that fat-derived stem cells are a safe and feasible treatment for people with SPMS.

The study, Adipose-derived mesenchymal stem cells (AdMSC) for the treatment of secondary-progressive multiple sclerosis: A triple blinded, placebo controlled, randomized phase I/II safety and feasibility study, was published in the journal PLOS One.

This is encouraging because very few therapies have been developed for the secondary progressive type of MS but don’t get carried away. This trial was all about safety and feasibility. It did not seek to measure the effectiveness of fat-derived stem cells as a treatment.

Trials with animal models of MS have shown that stem cells can help repair the central nervous system. This means they could potentially some of the neurodegeneration that leads to SPMS.

It was thought that Adipose or fat–derived stem cells (AdMSCs) are beneficial because they can be acquired easily. It can be done via a minimally invasive procedure called a lipectomy, which is a surgical procedure to remove body fat.

Fat-derived stem cells harvested by lipectomy

Despite the theories, the use of AdMSCs had not been tested in patients with SPMS. That’s the reason that researchers set out to determine the safety and feasibility of treating SPMS patients with two different doses of AdMSCs in a Phase 1/2 clinical trial (NCT01056471).

Researchers reported that they first obtained the AdMSCs from consenting patients through a lipectomy.

Then, 30 of these patients randomly receive either a single infusion of placebo, low-dose AdMSCs (1×106cells/kg), or high-dose ADMSCs (4×106cells/kg), and were then followed for 12 months. In total, 11 patients were given placebo, 10 were given low-dose, and nine were given high-dose AdMSCs.

During the treatment, only one adverse event was observed in the AdMSC treatment group, and that was not considered to be related to the treatment. The one event was a patient developed a urinary infection but there were no other safety issues.

Researchers concluded: “Although the study was not powered to determine the efficacy, some hint of efficacy was observed by the use of MRI and evoked potentials.

“Larger studies would be needed to investigate the potential therapeutic benefit of the technique.”

I shall certainly be watching future developments with interest, particularly as I was not able to proceed with hematopotetic stem cell transplantation (HSCT).

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50shadesofsun.com is the personal website of Ian Franks, a freelance medical writer and editor for various health information sites. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.

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Note: Health-related information available on 50shadesofsun website is for your general knowledge only. It is not a substitute for medical advice or treatment for specific medical conditions. I am not a doctor, so cannot and do not give you medical advice. You should seek prompt medical care for any specific health issues. Also, consult a doctor before starting a new diet or exercise programme. Any opinions expressed are purely my own unless otherwise stated.

Ocrevus: Counting Down to Expected FDA Approval

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There is now less than a month until the U.S. Food and Drug Administration (FDA) is expected to approve Ocrevus, generic name ocrelizumab, for use as a therapy for multiple sclerosis.

Clinical trials have shown Genentech’s drug to be a promising therapy for relapsing MS and, significantly, the primary progressive form of the disease for which there is no approved treatment.

ocrevusThe FDA is due to make its decision known March 28, which is quite poetic really, in that it is MS Awareness Month.

So, if everything works out, it looks as if Ocrevus, although not a cure, has all the makings of a wonder drug for MS, at least for most people who have the disease. That is because the vast majority of people with MS have the relapsing form, some 85% worldwide are diagnosed with this type..

However, if, like me, you have secondary progressive MS, then it seems Ocrevus will not be available. No claims have been made of Ocrevus having any effectiveness for our form of MS.

All drugs have side effects and this new one is no exception, but it seems that in all studies the most frequent side effects were mild-to-moderate reactions and infections related to the treatment’s injection.

But that is not enough information for me, and it should not be for you. I decided to dig a little deeper.

The UK’s MS Society says that not one of the Phase 3 trials reported any unexpected adverse side effects and in the Phase 2 relapsing remitting trial, serious side effects were rare and were comparable for all groups.

Wait a minute. Serious side effects?

The UK’s MS Trust also says they are rare and adds that opportunistic infections have not been reported in ocrelizumab MS trials.

Furthermore, in his article “Genentech’s Ocrevus: Pioneering The Progressive MS Therapy Landscape”, on Pharmaceutical Online, John Crowley, PhD, of Decision Resources Group, said: Ocrevus’ safety profile in MS program is very strong, but some question marks remain.”

It looks to me that, overall, the Ocrevus story is a very positive one.

This article, written by me, was first published by Multiple Sclerosis News Today.

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ian-skype_edited50shadesofsun.com is the personal website of Ian Franks, who is Managing Editor (columns division) of BioNews Services. BioNews is owner of 50 disease/disorder-specific news and information websites – including MS News Today. Ian has enjoyed a successful career as a journalist, from reporter to editor, in the print media. During that career he gained a Journalist of the Year award in his native UK. He was diagnosed with MS in 2002 but continued working until mobility problems forced him to retire early in late 2006. He now lives in the south of Spain. Besides MS, Ian is also able to write about both epilepsy and cardiovascular matters from a patient’s perspective and is a keen advocate on mobility and accessibility issues.

Getting to see neurologist proves not so simple

Ysbyty Gwynedd (Gwynedd Hospital), Bangor, North Wales. Place of my MS diagnosis and later consultations with MS nurse.

Ysbyty Gwynedd (Gwynedd Hospital), Bangor, North Wales. Place of my MS diagnosis and later consultations with MS specialist nurse.

Three or so years ago, I was sitting in a North Wales regional meeting of the UK’s MS Society and distinctly remember a society staffer saying that everyone with multiple sclerosis had a right to see a neurologist. If we wanted to see one, we only had to ask.

Well, in my case, I had not seen a neurologist for years having been transferred from him to seeing a specialist MS Nurse, had only ever had one MRI scan and that was prior to diagnosis in 2002, and had only ever been told that my MS was ‘benign’. In fact, at diagnosis the neurologist said that he did not expect my condition to deteriorate any faster in the future than it had in the previous 25+ years.

If I wanted to see him again, just tell the MS Nurse, I was told.

As is MS’s way, it did get worse and three years ago I was seeing the North Wales MS nurse every six months. So, on my next visit to him, I asked to see a neurologist. His reply was to ask me what good I thought it would do.

My reply was that I’d like to know exactly what type of MS I had and to discuss any medications he might think should be prescribed for me. The nurse’s reply let me speechless, not something for which I am known. He said that I had had RRMS but now had moved on to SPMS and that it was unnecessary for me to see a neurologist as there was no medication suitable for me.

Let me remind you this was a nurse, albeit a Specialist MS nurse, telling me what sort of MS he thought I had – without any further tests. It was just his opinion, and he blocked me from seeing a specialist doctor. Fortunately, this particular man has moved on now and North Wales has a new MS nurse.

Having moved from the UK to Spain, I now have to ask my new GP to refer me to a neurologist here. Maybe, I’ll now get a second MRI – 14 years after my previous one – and even find out exactly what type of MS I have.

Watch this space for further information.