OT Groundbreaking multiple sclerosis stem cell trial approved
Researchers from the Tisch MS Research Center of New York say the FDA has granted approval to begin early clinical investigation (phase 1 trial) of autologous neural stem cells in the treatment of MS.
Multiple sclerosis is a chronic disease that attacks the central nervous system (the spinal cord, optic nerves and brain). Common symptoms are numbness of the limbs, but more severe cases can lead to paralysis and blindness.
According to the Multiple Sclerosis Foundation, there are currently between 350,000 to 500,000 people in the US who have been diagnosed with MS, and 200 people are diagnosed with the disease every week.
The new regenerative strategy will involve using autologous, mesenchymal stem cell-derived neural progenitor cells (MSC-NPs), which will be harvested from the bone marrow of 20 MS patients who meet the criteria for the trial.
Spinal injections of stem cells
The stem cells will then be injected into the cerebrospinal fluid that surrounds the spinal cords of the patients.
MRI of brain showing multiple sclerosis
Multiple sclerosis is a chronic disease that attacks the brain, spinal cord and optic nerves.
The main objective of the clinical trial, the researchers say, is to determine the safety of the treatment, while the secondary objective is to measure the effectiveness.
The injections will be repeated at 3-month intervals, with their safety and efficacy frequently monitored through follow-up visits. After the final injection, patients will be monitored for up to 27 months.
Preclinical testing of this procedure showed that after injecting the stem cells, brain inflammation was reduced in seven MS patients, myelin was repaired (an insulating layer that forms around nerves), and protection of the neuronal structure and function of the brain was improved.