In recent days several Spanish media have echoed the news that a new stem cell treatment has made it possible for a patient with amyotrophic lateral sclerosis (ALS) to speak and run again. Information that is causing a stir among patients and family members and that It's not real, according to the Spanish Foundation for the Promotion of Investigation of Amyotrophic Lateral Sclerosis.
Different media have said that Mark Bedwell, an American suffering from the degenerative disease of fatal prognosis, was subjected to a stem cell treatment and, against all odds, has been able to speak again and even run.
Before the stir caused among those affected by this disease, the Foundation clarifies that there is no new treatment against the disease that affects 4,000 people in Spain, but, for the moment, this therapy It is in the experimentation phase and the actual results are unknown.
Experimentation of a new treatment
The BrainStorm Cell Therapeutics laboratory is developing a therapy that involves using mesenchymal stem cells which become cells that produce neurotrophic factors. These stem cells are injected into the cerebrospinal fluid. It is hoped that they can slow the progression of degeneration of motor neurons and therefore the progression of ALS symptoms.
In 2012, BrainStorm appeared in the media worldwide with the story of a rabbi who regained the ability to walk and speak after receiving a stem cell treatment. Since then, the popular belief that stem cells are miraculous healing agents has led NurOwn's clinical trials to be among the most popular with regard to therapeutic experimentation in this field.
At the moment it is unknown if the treatment is working, publications about whether it is effective with full certainty are scarce
In 2016 the first articles reviewed by experts on the safety data of these studies were published, while BrainStorm ended the Phase 2 clinical trial in three well-known American clinics. After these tests, a series of promising data regarding their safety was obtained and some optimism was installed regarding the possible effects of the treatment, although there was no statistically significant evidence. As of today, these data have not yet been published.
In 2017 the clinical trial started in Phase 3 with 200 participants, in six centers in the United States selected by the company. The recruitment of more than half of the participants needed for this study has already been made. The results of the current phase of this trial They will be published at least as of the second half of 2020.
It is unknown if it is effective
Given these data, the Foundation indicates that It is not known if this treatment is working, publications on whether the treatment is effective with full certainty are scarce. There are no articles reviewed by ELA experts, about the results of the clinical trial in Phase 2, and the studies that have led to a phase 3. If the study turns out to be positive in Phase 3, we hope that they provide the necessary information on the slowdown process in the progress of the ELA.
The results of the current phase of this trial will be published, at a minimum, from the second half of 2020
From the International Alliance of Associations of ELA and its scientific committee, we maintain the hopes that it really works, as with the rest of therapies that are currently being tested. Although the development process has not been precisely the best in terms of the transmission of information, based on anecdotal evidence of the people involved in the trials and the effects communicated by the participants themselves, the scientific community maintains an attitude of moderate optimism.
With respect to Phase 3, we hope that BrainStorm's attitude, be as scientific as possible, keeping hope objectively and avoiding disappointment of patients.