10. Safety assessment of umbilical cord mesenchymal stem cell transplantation in combination with rehabilitation in ischemic stroke patients

Nguyen Thi Ngoc Thuy, Phung Nam Lam, Ngo Van Doan, Le Thu Huong, Nguyen Thi Phuong Anh, Pham Thi Bich, Nguyen Trung Kien, Hoang Minh Duc, Nguyen Quang Anh, Nguyen Thi Viet Ha, Pham Van Minh, Nguyen Thanh Liem

Main Article Content

Abstract

Umbilical cord mesenchymal stem cell therapy (UC-MSC) is evaluated as a potential and effective for brain recovering in the treatment of neurological diseases, including ischemic stroke. The study was conducted to evaluate the safety of UC-MSC therapy through two intravenous and intrathecal administration in the ischemic stroke patients. The method was a phase I clinical trial in 10 ischemic stroke patients, assessing safety through the occurrence of adverse events (AEs), serious adverse events (SAEs) and initial results through NIHSS and FIM at 3 months, 6 months and 12 months. The results showed that there was none of any SAEs, there were 4 AEs in the intravenous group and 6 AEs in the intrathecal group and there was an improvement in NIHSS score and FIM score after 12 months of intervention. We concluded that UC-MSC therapy is safe and initially effective in improving neurological sequelae after ischemic stroke, as such it is necessary to transition to phase II to further evaluate the UC-MSC effectiveness.

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References

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