Treatment of Osteoarthritis of the Knee with stem cells

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Treatment of Osteoarthritis of the Knee with stem cells

Image ITRT: treatment of osteoarthritis of the knee with stem cells.

Osteoarthritis and treatment of osteoarthritis of the knee with stem cells

Osteoarthritis is a disorder caused by wear and tear on the joint cartilage and can affect any joint in the body causing varying degrees of pain and deformity. It can often progress slowly, not require treatment or be well controlled by medication or physiotherapy. However, it can also cause pain and make it extremely difficult to walk and even require replacement of the joint.

Treatment of osteoarthritis of the knee with stem cells has achieved significant relief of pain and walking difficulties in over 90% of treated patients. The improvement in pain and functional disability is experienced between 1 and 3 months and progressive improvement continues after both the first and second years.

Using a magnetic resonance imaging procedure called Cartigram, it was found that the treatment of knee osteoarthritis with stem cells can not only stop the progressive loss of cartilage but may even lead to an increase in cartilage. We have found that this regeneration occurs in 95% of treated patients.

These results were obtained in 25 patients in two controlled clinical trials approved and monitored by the Spanish Agency for Medicines and Medical Devices (AEMPS). Preliminary results from the first clinical trial have just been published in the scientific journal Transplantation.

Due to the lack of complications and the excellent efficacy observed, the AEMPS has been able to authorise ITRT to continue to administer personalised treatments on a "compassionate use" basis. It has also allowed the research team to apply the treatment to other joints, such as the hip, ankle, feet, shoulder, elbow, wrist and joints of the hand.  The results in the other joints, although with different time scales, are following the same pattern in terms of improvement in pain and signs of regeneration as found in the knee.

Up to September 2013, over 190 patients have received this treatment. All are under follow-up by our group according to the same methodology as used in the clinical trial, through check-up visits, health questionnaires and Cartigram magnetic resonance imaging.

 

How is the treatment of osteoarthritis of the knee with stem cells carried out?

First of all, at no cost, the medical team assesses whether the treatment is indicated from the medical history, examination and study of X-rays and Cartigram magnetic resonance imaging. 

Preoperative studies are performed: blood tests, including serology for infections for safety reasons, chest X-ray and electrocardiogram.

The AEMPS is asked to authorise personalised treatment.

If all goes well, the patient is scheduled for two processes to be performed:

 

 

First stage: Obtaining bone marrow

 

This procedure is done as outpatient surgery with the patient having fasted for six hours. The patient is positioned face down and the surgical site is prepared antiseptically. A local anaesthetic is given plus sedation, similar to that used for a colonoscopy, and about 100 cc (a tenth of a litre) of bone marrow is aspirated from the pelvic bone (through the buttock). The process takes about 25 minutes. Afterwards, ice is applied to the site and once the patient is fully awake, they are transferred to the recovery room where they remain for about 20 minutes. The ice is then removed and the patient can be discharged.

Relative rest is recommended for 24-48 hours.

The bone marrow is sent to our cell culture laboratory where it is processed for 3 weeks, after which the doctors are supplied with a product containing 40 million stem cells.

 

Second stage: Injection of cells into the knee or other joint

The patient arrives at the outpatient surgery unit having fasted for six hours.

The patient is positioned face down and the sterile surgical site prepared antiseptically. The cell product is then injected into the joint (the procedure is the same as for the injection of any medication).  A simple dressing is applied.

After about 10 minutes in the recovery room, the patient is ready for discharge.

Total rest at home is recommended for 48 hours, followed by relative rest for a week.

After that, check-ups and rehabilitation will be adapted to suit each individual's progress.