TEL AVIV (Reuters) – BrainStorm Cell Therapeutics Inc received approval from Israel's Health Ministry for a clinical trial of its adult stem cell therapy for people with amyotrophic lateral sclerosis (ALS).
"The trial represents a significant step forward in our goal of using stem cells with neuro restoration capabilities to treat ALS," Adrian Harel, acting CEO of BrainStorm, said on Tuesday.
BrainStorm expects to begin treating patients in the coming weeks and will work with Jerusalem's Hadassah Medical Center.
The U.S. Food and Drug Administration in February granted orphan drug designation to the company's NurOwn adult stem cell product for the treatment of ALS, also known as Lou Gehrig's Disease.
The initial phase of the study is designed to establish the safety of NurOwn and will later be expanded to assess efficacy.
Patients will be transplanted with stem cells derived from their own bone marrow and treated with the NurOwn stem cell technology. The trial will include 24 patients, 12 in an advanced stage of the disease and 12 in an early stage.
The patients will be examined at regular intervals and followed for six months post transplantation.
ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. According to the ALS Association, 5,600 people in the United States are diagnosed with ALS each year and it is estimated that as many as 30,000 Americans may have the disease at any given time.
(Reporting by Tova Cohen; Editing by David Holmes)
"The trial represents a significant step forward in our goal of using stem cells with neuro restoration capabilities to treat ALS," Adrian Harel, acting CEO of BrainStorm, said on Tuesday.
BrainStorm expects to begin treating patients in the coming weeks and will work with Jerusalem's Hadassah Medical Center.
The U.S. Food and Drug Administration in February granted orphan drug designation to the company's NurOwn adult stem cell product for the treatment of ALS, also known as Lou Gehrig's Disease.
The initial phase of the study is designed to establish the safety of NurOwn and will later be expanded to assess efficacy.
Patients will be transplanted with stem cells derived from their own bone marrow and treated with the NurOwn stem cell technology. The trial will include 24 patients, 12 in an advanced stage of the disease and 12 in an early stage.
The patients will be examined at regular intervals and followed for six months post transplantation.
ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. According to the ALS Association, 5,600 people in the United States are diagnosed with ALS each year and it is estimated that as many as 30,000 Americans may have the disease at any given time.
(Reporting by Tova Cohen; Editing by David Holmes)
