Treatment of Lumbar Disc Disease with stem cells

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Treatment of Lumbar Disc Disease with stem cells

Image: ITRT

Application of the stem cell treatment for lumbar disc disease

The Institute for Regenerative Medicine ITRT, a pioneer in clinical research and stem cell therapy, has confirmed that adult stem cells are appropriate for use in the treatment of certain degenerative changes of the intervertebral disc, known as lumbar disc disease, which are the cause of chronic low-back pain. The treatment can be used in patients who have chronic low-back pain caused by lumbar disc degeneration.
 

 

 

What is chronic low-back pain?

 

 

Chronic low-back pain is pain in the lumbar region which persists and refuses to go away. One of the most common causes of chronic low-back pain is intervertebral disc degeneration. In most cases, this degenerative process is asymptomatic or mild and no treatment is required, but if pain develops and persists over time, different procedures need to be tried in order to improve the patient's condition.

Low-back pain is the second-leading cause of sick leave and, according to data from the European Commission Directorate-General for Research and Innovation, is responsible for the loss of 700,000 working days every year. It affects 67 million people in the European Union, with 5 million in Spain. It is estimated that 75% of the population will suffer from low-back pain at some point in their lives. In 90% of cases it resolves within 3 months, but in 5%-10% it becomes chronic.

 

What is the usual treatment?

There are different ways of treating chronic low-back pain caused by degenerative changes depending on a number of aspects, such as the intensity or frequency of the pain.

• Initially the treatment aims at stabilising the lumbar spine through exercises, correcting poor posture, losing weight if necessary and administering painkillers and muscle relaxant medications.

• When the pain persists, patients are often referred to specialised centres for courses of physiotherapy and rehabilitation, and injections in different variants may be resorted to.

If the pain caused by the lumbar disc disease continues to persist despite the different treatments, surgical procedures will sometimes be tried, such as stopping the movement in the affected space. In Spain, some 1,000 spinal fusion or arthrodesis operations are performed annually, and some 40,000 are performed in the US.

 

How are adult stem cells used in the treatment of chronic low-back pain?

In cases where this is considered to be the appropriate treatment, the Spanish Agency for Medicines and Medical Devices is asked to authorise personalised treatment.

The first step is to obtain bone marrow from the patient's pelvic bone. The sample is sent to the cell therapy laboratory at the Instituto de Biología Genética Molecular (IBGM) [Institute for Biology and Molecular Genetics] in Valladolid, which has the necessary accreditation to produce stem cells for use in humans. Over 3 weeks, the stem cells are selected and cultured until about 20 million are obtained. The resulting cell product is then injected, under radioscopic guidance, through the skin into the affected vertebral disc. Both the procedure for obtaining the cells and application of the therapy are performed in the operating theatre under mild sedation and local anaesthetic. There is no need for admission to hospital.
 

What are the risks?

Up to now, the procedure has been shown to be viable. No adverse effects caused by the cell product have been reported.
 

What results have been obtained with the treatment of lumbar disc disease with stem cells?  

In the clinical trial conducted, the patients with lumbar disc disease were followed up and assessed for a year. In 9 out of 10 of the cases treated, significant improvements were found in both low-back pain and disability. One year later, the intervertebral discs in five of the patients included in the study showed signs of regeneration, such as an increase in height and in hydration. To date, over 75 patients have been treated with very similar outcomes.

The assessment of efficacy, compared with current surgical solutions, can be considered similar or even higher, with the advantage that it is a simple and non-invasive conservative intervention that preserves the biomechanics of the spine and does not preclude future therapies if found ineffective.

At present the AEMPS regularly authorises the ITRT research team to continue to use this cell therapy in selected cases under their supervision.

 

Have the results of any studies been published?

The pilot study was started in 2007 with the objective of assessing the regenerative capacity of the lumbar intervertebral disc following percutaneous implantation of bone marrow mesenchymal progenitor cells. The trial was conducted in accordance with the agreement between the Centro Médico Teknon Regenerative Medicine Unit and the Instituto de Salud Carlos III, which is now affiliated with the Ministry of Finance, within the framework of the Advanced Therapies Plan set up by the Ministry of Health in 2007, and is the result of network research made possible by the Red Tercel [Cell Therapy Network] of the aforementioned Carlos III Institute. The study results were published in 2011 in the influential US scientific journal "Transplantation", which is cited over 25,000 times per year.