Autologous Stem Cell Trials for ALS Patients
A clinical trial of stem cell therapy for ALS patients conducted by Israel-based BrainStorm Cell Therapeutics shows the treatment to be well-tolerated, safe and not presenting risk of side-effects, an interim safety review says. In addition to that, some patients report improvement in their condition.
The Phase I/II trial has been designed to assess the safety and preliminary effectiveness of BrainStorm's stem cell therapy called NurOwn stem cell technology. Trial participants received their own bone marrow stem cells and were treated with the NurOwn. The safety and tolerability data were reassuring.
In addition to that, the researchers have been surprised to receive signs of the treatment efficacy in the early clinical trials aimed at safety evaluation. Some patients demonstrated improvement in breathing, others muscle strength increase and others speech improvement. One patient, Rabbi Rafael Shmuelevitz of Jerusalem, reported significant improvement. Having myasthenia gravis (a neuromuscular disease) in addition to ALS, he was transplanted a higher stem cell dose than other patients. Before the treatment, he could not walk without being helped from both sides due to disequilibrium he suffered, but now he can walk even without a cane.
The final report on the trial will be available by the end of the year after nine months observation of each of the patients. The researchers suggest that stem cell treatment may not only improve the condition of ALS sufferers but also cure the disease.
Now BrainStorm is waiting for the U.S. Food and Drug Administration approval to continue ALS trials at the University of Massachusetts and Massachusetts General Hospital. In Phase II, the researchers will study safety and preliminary efficacy of additional stem cell dosages.