BACKGROUND AIMS: The term "cerebral palsy" (CP) encompasses many syndromes that emerge from brain damage at early stages of ontogenesis and manifest as the inability to retain a normal body position or perform controlled movements. Existing methods of CP treatment, including various rehabilitation strategies and surgical and pharmacological interventions, are mostly palliative, and there is no specific therapy focused on restoring injured brain function. METHODS: During a post-registration clinical investigation, the safety and efficacy of intravenous infusion of allogeneic human leukocyte antigen (HLA)-unmatched umbilical cord blood (UCB) cells were studied in 80 pediatric patients with cerebral palsy and associated neurological complications. Patients received up to 6 intravenous infusions of AB0/Rh-identical, red blood cell-depleted UCB cells at an average dose of 250 × 10(6) viable cells per infusion. RESULTS: Patients were followed for 3-36 months, and multiple cell infusions did not cause any adverse effects. In contrast, in most patients who received four or more UCB cell infusions, positive dynamics related to significant improvements in neurological status and/or cognitive functions were observed. CONCLUSIONS: The results confirm that multiple intravenous infusions of allogeneic AB0/Rh-identical UCB cells may be a safe and effective procedure and could be included in treatment and rehabilitation programs for juvenile patients with cerebral palsy.
BACKGROUND AIMS: The term "cerebral palsy" (CP) encompasses many syndromes that emerge from brain damage at early stages of ontogenesis and manifest as the inability to retain a normal body position or perform controlled movements. Existing methods of CP treatment, including various rehabilitation strategies and surgical and pharmacological interventions, are mostly palliative, and there is no specific therapy focused on restoring injured brain function. METHODS: During a post-registration clinical investigation, the safety and efficacy of intravenous infusion of allogeneic human leukocyte antigen (HLA)-unmatched umbilical cord blood (UCB) cells were studied in 80 pediatric patients with cerebral palsy and associated neurological complications. Patients received up to 6 intravenous infusions of AB0/Rh-identical, red blood cell-depleted UCB cells at an average dose of 250 × 10(6) viable cells per infusion. RESULTS:Patients were followed for 3-36 months, and multiple cell infusions did not cause any adverse effects. In contrast, in most patients who received four or more UCB cell infusions, positive dynamics related to significant improvements in neurological status and/or cognitive functions were observed. CONCLUSIONS: The results confirm that multiple intravenous infusions of allogeneic AB0/Rh-identical UCB cells may be a safe and effective procedure and could be included in treatment and rehabilitation programs for juvenile patients with cerebral palsy.
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