http://dgnews.docguide.com/improved-function-maintained-over-2-years-stem-cell-therapy?
January 30, 2018
By Alex Morrisson
LOS ANGELES -- January 30, 2018 -- Gains in function made with stem cell infusions into the brain are maintained by recovering stroke patients 2 years after the intervention, according to a study presented here at the 2018 International Stroke Conference (ISC).
“Neurological circuits are not irreversibly damaged,” said Gary Steinberg, MD, Stanford Stroke Center, Stanford University, Stanford, California, on January 25. “Intraparenchymal transplantation of human modified bone marrow-derived stromal cells in chronic stroke patients is safe and feasible.”
Significant neurological improvements were seen at 6, 12, and 24 months. Of 18 patients in the study, 14 have improved significantly, he reported.
The open-label safety study enrolled 18 patients who had had a stroke. The patients were given 1 of 3 transplant doses, ie, 2.5 million, 5 million, and 10 million cells, which were inserted into the brain around the region of the infarct caused by the original stroke. The strokes occurred 7 to 36 months before the cells were implanted.
The patients were diagnosed with modified Rankin scores of 3 or 4, indicating deficits in motor function. They had National Institutes of Health Stroke Scale scores of ≥7. The strokes were centred in the subcortical area around the middle cerebral artery.
“We thought the stem cells would create neural progenitor cells that in turn would produce oligodendrocytes, astrocytes, and neurons or that the bone marrow-derived stem cells would transform into endothelial cells, and we were wrong in both counts,” Dr. Steinberg said. “The cells appear to produce growth factors that produce angiogenesis, neurogenesis, gliogenesis, synaptogenesis, and downregulation of inflammation.”
The serious adverse events experienced by the patients included a seizure that occurred 70 days after transplant, an asymptomatic subdural hygroma/haematoma that was drained without sequalae, pneumonia, and a urinary tract infection with sepsis. One patient underwent stenting of the cervical carotid artery for asymptomatic stenosis. One patient developed a transient ischaemic attack 11 months after the transplant that subsequently resolved, and another experienced transient paraesthesia and dysphagia that also resolved.
The patients showed improvement in the European Stroke Score, a 2-point drop from baseline in the NIH Stroke Scale International score, a 20-point improvement from baseline in the Fugl-Meyer total score, and a 10-point improvement in the Fugl-Meyer Motor Function total score.
“Cell transplantation therapy for stroke holds great promise,” Dr. Steinberg concluded. “Investigation of neurotransplantation is still in its early stages. Many fundamental issues need to be resolved in preclinical studies.”
The researchers have enrolled 156 patients with chronic traumatic brain injury in a phase 2b study.
Funding for the study was provided by SanBio.
[Presentation title: Two-Year Safety and Clinical Outcomes in Chronic Ischemic Stroke Patients After Implantation of Modified Bone Marrow-Derived Mesenchymal Stem Cells (sb623): A Phase 1/2a Study. Abstract LB14]
LOS ANGELES -- January 30, 2018 -- Gains in function made with stem cell infusions into the brain are maintained by recovering stroke patients 2 years after the intervention, according to a study presented here at the 2018 International Stroke Conference (ISC).
“Neurological circuits are not irreversibly damaged,” said Gary Steinberg, MD, Stanford Stroke Center, Stanford University, Stanford, California, on January 25. “Intraparenchymal transplantation of human modified bone marrow-derived stromal cells in chronic stroke patients is safe and feasible.”
Significant neurological improvements were seen at 6, 12, and 24 months. Of 18 patients in the study, 14 have improved significantly, he reported.
The open-label safety study enrolled 18 patients who had had a stroke. The patients were given 1 of 3 transplant doses, ie, 2.5 million, 5 million, and 10 million cells, which were inserted into the brain around the region of the infarct caused by the original stroke. The strokes occurred 7 to 36 months before the cells were implanted.
The patients were diagnosed with modified Rankin scores of 3 or 4, indicating deficits in motor function. They had National Institutes of Health Stroke Scale scores of ≥7. The strokes were centred in the subcortical area around the middle cerebral artery.
“We thought the stem cells would create neural progenitor cells that in turn would produce oligodendrocytes, astrocytes, and neurons or that the bone marrow-derived stem cells would transform into endothelial cells, and we were wrong in both counts,” Dr. Steinberg said. “The cells appear to produce growth factors that produce angiogenesis, neurogenesis, gliogenesis, synaptogenesis, and downregulation of inflammation.”
The serious adverse events experienced by the patients included a seizure that occurred 70 days after transplant, an asymptomatic subdural hygroma/haematoma that was drained without sequalae, pneumonia, and a urinary tract infection with sepsis. One patient underwent stenting of the cervical carotid artery for asymptomatic stenosis. One patient developed a transient ischaemic attack 11 months after the transplant that subsequently resolved, and another experienced transient paraesthesia and dysphagia that also resolved.
The patients showed improvement in the European Stroke Score, a 2-point drop from baseline in the NIH Stroke Scale International score, a 20-point improvement from baseline in the Fugl-Meyer total score, and a 10-point improvement in the Fugl-Meyer Motor Function total score.
“Cell transplantation therapy for stroke holds great promise,” Dr. Steinberg concluded. “Investigation of neurotransplantation is still in its early stages. Many fundamental issues need to be resolved in preclinical studies.”
The researchers have enrolled 156 patients with chronic traumatic brain injury in a phase 2b study.
Funding for the study was provided by SanBio.
[Presentation title: Two-Year Safety and Clinical Outcomes in Chronic Ischemic Stroke Patients After Implantation of Modified Bone Marrow-Derived Mesenchymal Stem Cells (sb623): A Phase 1/2a Study. Abstract LB14]
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