Autoimmune diseases significantly impact the lives of patients who develop the conditions. Relapse remitting multiple sclerosis (RRMS) and neuromyelitis optica (NMO) are two conditions where the immune system affects the nerves in the body. For NMO patients, the nerves in the spinal cord and eyes are damaged and can lose their ability to function. For RRMS patients, the myelin sheath of the nerves is destroyed, which can cause damage to patient feeling, mobility, balance, bladder function, and more.
Current multiple sclerosis treatments have unwelcoming side effects, such as a suppressed immune system, and potentially deadly effects, such as progressive multifocal leukoencephalopathy. NMO patients do not fare much better in current treatments, which mainly involve suppressing the immune system. These treatments can cause adverse events, such as organ damage and infection.
Developing more effective treatments for both RRMS and NMO patients is necessary to improve patient outcomes. Treating patients with human umbilical cord mesenchymal stem cells (hUC-MSCs) is a potential method to improve patient quality of life.
The long-term effects of stem cell therapy on patients with multiple sclerosis have not been widely studied. Additionally, more long-term research is needed on NMO patients and stem cell therapy. Confirming that this therapy is safe and effective in the long term will go a long way in developing better treatments.
A long-term study, IV/IT hUC-MSCs Infusion in RRMS and NMO: A 10-Year Follow-Up Study, looked into the results of patients with RRMS and NMO 10 years after being treated with stem cells. This study backs up the claims that stem cell therapy is safe in the long term.
The Results of the Study
Ten patients with RRMS and NMO were recruited for the study between April 2009 and December 210. The patients have been dealing with their conditions for more than four years and had Expanded Disability Status Scale (EDSS) scores between 2.5 and 8.5. Patients also did not respond to conventional treatments. There were five NMO patients and five MS patients.
Patients received four infusions of 40,000,000 hUC-MSCs that were intravenously infused seven days apart. Patients also received 20,000,000 hUC-MSCs that were administered intrathecally three times over seven days. Additionally, patients did not receive immune system modifying medicines during the treatment.
The study evaluated patient EDSS scores and number of relapses over the course of 10 years. Patient relapses were identified by looking for new lesions on the brain and spinal cord via MRI. The researchers looked for short-term adverse events and long-term adverse events. The study followed up with patients every three months in the first year and once a year for ten years after the first year.
Two patients were lost to follow-up after two years, and three patients passed away from complications, such as pneumonia and pulmonary embolism, during the course of the study. Those events were not likely related to the stem cell treatment. The study continued to follow the rest of the patients for the length of the 10-year study.
The treatment generally showed improvements for patients in the short term. One month after receiving treatment, all five NMO patients and four MS patients showed improvements in EDSS scores. All patients had reduced annual relapse occurrences both one and two years after receiving treatment. Nine out of the ten patients showed a reduced number of relapse occurrences in the long term.
Stem cell therapy was well tolerated in patients over the course of the study. No patients had developed tumors over the course of the study. Additionally, there were no other organ disorders that occurred as a result of the treatment. The researchers found that patients had no short-term or long-term adverse effects.
The researchers concluded that human umbilical cord mesenchymal stem cell therapy is safe and feasible in the long term for RRMS and NMO patients. The combined intravenous and intrathecal administration of umbilical cord stem cells in this study provided a unique opportunity to showcase that this treatment method is safe.
This study is vital in showcasing that stem cell therapy is safe in the long-term. There are few studies that follow patients who were treated with stem cells for more than five years. More research is needed to confirm that stem cell therapy is an effective treatment for patients who are suffering from multiple sclerosis and neuromyelitis optica. There likely will be continued studies into the effects of stem cell therapy on autoimmune disease patients in the long term.