People with multiple sclerosis have been waiting for this: A full-scale clinical trial testing the effectiveness of stem cell transplantation as an MS treatment. The trial is being conducted by the U.S. National Institutes of Health, and it’s enrolling people with MS at several centers in the United States and one in the United Kingdom.
The U.S. has been behind the curve when it comes to approving stem cell treatments for people with MS. Autologous hematopoietic stem cell transplantation (aHSCT) has been available in Mexico and Russia for several years, but isn’t widely available in the U.S.
In the procedure, doctors collect a patient’s blood-forming stem cells, give the patient high-dose chemotherapy to deplete the immune system, and then return the patient’s own stem cells to rebuild the immune system. The system, hopefully, returns free of cells believed to be involved with MS.
Three years ago, following a promising aHSCT study, Dr. Anthony Fauci was optimistic but cautious. Fauci is the director of the National Institute of Allergy and Infectious Diseases. He said, “These extended findings suggest that one-time treatment with HDIT/HCT may be substantially more effective than long-term treatment with the best available medications for people with a certain type of MS.” But Fauci emphasized that a larger trial was still necessary. It appears that trial has finally arrived.
BEAT-MS is enrolling participants
It will enroll 156 adults, ages 18 to 55, with a diagnosis of relapsing-remitting MS (RRMS) at 21 sites — 20 in the U.S. and one in the U.K. Participants will be randomly assigned to receive either aHSCT or one of the high-efficacy MS treatments currently in use: Ocrevus (ocrelizumab), Lemtrada/Campath (alemtuzumab), Tysabri (natalizumab), or Rituxan (rituximab). The participants, who won’t know which treatment they’re receiving, will be followed for six years.
In a news release, investigators said they want to compare how much time elapses between the start of the treatment and an MS relapse. They’ll also compare the newly developing immune systems of the participants who receive aHSCT with the immune systems of those who receive a DMT.
Finally, they’ll compare the effects of the two treatment types on other measures of disease activity and severity, their cost-effectiveness in terms of healthcare costs and productivity, and participants’ quality of life. “We hope that BEAT-MS will clarify the best way to treat people with relapsing MS,” said Dr. Jeffrey Cohen, the trial’s leader.
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