New innovative stem cell therapy developed by Hadassah University Hospital in Jerusalem and the Israeli company NeuroGenesis has led to significant clinical improvement in patients with progressive multiple sclerosis. It shows the first results in a clinical phase II study, writes the newspaper Jerusalem Post.
The results of the placebo-controlled study showed that the treatment not only stopped the progression of the disease, but even stopped it – the result has been published in Oxford University’s journal Brain.
Multiple sclerosis (MS) is an autoimmune disease that affects more than 2.3 million people. people all over the world. The disease damages the myelin (nervous system), which protects and isolates the nerve fibers and contributes to the efficient transmission of nerve impulses – also the nerve cells in the central nervous system, leading to neurological disability.
People with MS often experience pain in the limbs or numbness, they may also have difficulty walking, use their hands or even become completely paralyzed. The condition is also associated with virus problems. At the time of writing, there is no cure and people suffering from progressive MS have few, if any, treatment options. Existing treatments can only reduce relapse or slow the disease.
Uses bone marrow stem cells
Treatment on Hadassah, called NG-01, uses an “autologous proprietary subpopulation of mesenchymal stem cells,” in other words, the treatment uses cells from the bone marrow to treat the MS patient. This ensures that the patient’s body does not reject treatment. The cells are injected into the patient’s spinal cord, directly into the central nervous system.
The cells move into the damaged area of the patient and create an “ecosystem that repairs” the damage, explains NeuroGenesis CEO Tal Gilat. The process is relatively simple and only takes 20 minutes with local anesthesia. The patient subsequently spends a few hours in the hospital for observation and can then be discharged.
– Patients3 improvement was in many cases extremely dramatic, says Gilat.
Nearly 60 percent of patients showed no evidence of disease activity throughout the treatment period, compared with 10 percent in the placebo group. This corresponds to an 85 percent reduction in the development of the disease. About 20 percent of those who received the stem cell treatment already showed an improvement after the first treatment. After six months, 73 percent experienced not only that the disease had not worsened, but even an improvement.
Patient could run several kilometers
The groundbreaking treatment has also improved patients’ ability to walk, increased their muscle power, their neurological improvements in cognitive function and improvements in their fine motor skills. MRI scans also showed improvements in patients’ overall motor function. Gilat described patients who could walk again and one who went from struggling to move to being able to run several kilometers after treatment.
The Phase II study involved 48 patients. During phase I, about 140 patients received the treatment. There have been no serious side effects after treatment so far. Gilat stresses that the treatment does not “deal with the underlying cause of the disease”, which is still unknown.
“We are improving the symptoms,” says Gilat
The next round of treatment is a Phase III study in the US, Europe and Israel and subsequently apply for approval. It can take two to four years. Hadassah Hospital and NeuroGenesis have also conducted studies at an early stage of the disease with the same treatment in patients with amyotrophic lateral sclerosis (ALS) – the treatment also shows good results here.