Phase 1 Trial of Autologous Bone Marrow Stem Cell Transplantation in Patients with Spinal Cord Injury

Abstract

Introduction. A total of 18 patients, with complete motor deficits and paraplegia caused by thoracic and lumbar spine trauma without muscle atrophy or psychiatric problems, were included into this study. Materials and Methods. The bone marrow was aspirated from the anterior iliac crest under local anesthesia and the mononuclear fraction was isolated by density gradient method. At least 750 million mononuclear-enriched cells, suspended in 2 mL of saline, were infused intrathecally. Results and Discussion. The study reports demonstrated improvement of motor and sensory functions of various degrees observed in 9 of the 18 (50%) cases after bone marrow stem cell transplantation. Measured by the American Spinal Injury Association (ASIA) scale, 7 (78%) out of the 9 patients observed an improvement by one grade, while two cases (22%) saw an improvement by two grades. However, there were no cases in which the condition was improved by three grades. Conclusions. Analysis of subsequent treatment results indicated that the transplantation of mononuclear-enriched autologous BMSCs is a feasible and safe technique. However, successful application of the BMSCs in the clinical practice is associated with the necessity of executing more detailed examinations to evaluate the effect of BMSCs on the patients with spinal cord injury.

Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)

“…A number of clinical studies concerning cell therapies with a positive outcome have led to the suggestion that combination cell therapies and/or certain transplantation approaches with rehabilitation can be more effective 107 , 123 , 128 – 130 , 136 , 138 – …”

Multichannel polymer scaffold seeded with activated Schwann cells and bone mesenchymal stem cells improves axonal regeneration and functional recovery after rat spinal cord injury

“…When used as grafts, these cells have the potential for clinical autologous transplantation, without the risk of severe immune rejection. Clinical investigations have indicated that the transplantation of autologous MSCs is feasible and safe [47][48][49][50] . PLGA has been widely used as an artificial catheter, drug controlled-release carrier, and tissue engineering scaffold material for its mechanical properties and biodegradation.…”

2016 yearbook of neurorestoratology

“…More evidence of improving function for patients with complete chronic SCI has been reported using a variety of different cell-based therapies, including umbilical cord blood-derived mononuclear cell transplants for spinal cord and locomotor training, 30 the mononuclear-enriched bone marrow cell transplantation through intrathecal infusion, 31 bone marrow MSC transplantation through lumbar puncture into subarachnoid space, 32 a combination of neuronal cells differentiated from autologous adipose tissue-derived mesenchymal stem cells, and hematopoietic stem cells through intrathecal infusion, 33 and olfactory mucosa lamina propria transplants into the spinal cord. 34 Promising results for patients with ALS have been reported by intraspinal injection of bone marrow-derived neural stem cells, in which patients experienced a temporary stabilization for the first few months postinjection and then gradually deteriorated.…”