A clinical trial report of autologous bone marrow-derived mesenchymal stem cell transplantation in patients with spinal cord injury

Abstract

Spinal cord injury (SCI) is a severe neurological disease. An effective strategy for the treatment of SCI is urgently required. Stem cell transplantation has emerged as a viable therapeutic option with great potential for restoring neurological function lost following SCI. From 2009 to 2010, a total of 20 SCI patients were enrolled in a clinical trial by Wuhan Hongqiao Brain Hospital; all patients completed and signed informed consent prior to autologous bone marrow-derived mesenchymal stem cell transplantation. Analysis of subsequent treatment results indicated significant improvements in sensory, motor and autonomic nerve function as assessed by the American Spinal Injury Association’s impairment scale. Thirty days after transplantation, a total of 15 patients (75%) demonstrated improvement, including four of the eight patients (50%) with grade A SCI, three of the four patients (75%) with grade B injury and all eight patients (100%) with grade C injury. The most common adverse events, fever and headache, disappeared within 24–48 h without treatment.

An approach to personalized cell therapy in chronic complete paraplegia: The Puerta de Hierro phase I/II clinical trial

“…At present, cell therapy is a therapeutic promise in this field of research [1][2][3][4][5][6][7][8][9] but still subject to many uncertainties, with significant confusion due to the disparity of protocols, selection of subjects, cell type, dose and routes of administration used.…”

Transplantation of stem cell-derived astrocytes for the treatment of amyotrophic lateral sclerosis and spinal cord injury

“…With a special focus on chronic SCI conditions, many clinical trials based on the transplantation of unmodified mesenchymal, neural or bone-marrow stem cells have been launched around the world [167][168][169][170][171] . Among phase 1 studies, most of them have focused on safety measurements and graft survival according to different routes of administration (mostly intrathecal or focal intraparenchymal delivery).…”

“…Recent studies however have elucidated their heterogeneity and the changes exhibited by these cells following SCI, thereby underscoring the need to preserve their normal physiological functions. Studies mentioned above, as well as other studies that are not detailed here, are indicative of the growing appreciation of cell transplantation therapies for therapeutically targeting astrocytes in SCI.With a special focus on chronic SCI conditions, many clinical trials based on the transplantation of unmodified mesenchymal, neural or bone-marrow stem cells have been launched around the world [167][168][169][170][171] . Among phase 1 studies, most of them have focused on safety measurements and graft survival according to different routes of administration (mostly intrathecal…”

Bone Marrow-derived Mesenchymal Stem Cell Transplant Survival in the Injured Rodent Spinal Cord

“…There have been some early clinical trials assessing the safety and primary efficacy of MSC transplantation into spinal cord injured patients, concluding that MSC transplantation is feasible and safe [62,63]. Larger randomized, controlled, blinded clinical trials are needed to assess efficacy of MSCs in humans.…”