An approach to personalized cell therapy in chronic complete paraplegia: The Puerta de Hierro phase I/II clinical trial.
Cell transplantation in patients suffering spinal cord injury (SCI) is in its initial stages, but currently there is confusion about the results because of the disparity in the techniques used, the route of administration, and the criteria for selecting patients.



We conducted a clinical trial involving 12 patients with complete and chronic paraplegia (average time of chronicity, 13.86 years; SD, 9.36). The characteristics of SCI in magnetic resonance imaging (MRI) were evaluated for a personalized local administration of expanded autologous bone marrow mesenchymal stromal cells (MSCs) supported in autologous plasma, with the number of MSCs ranging from 100 × 10(6) to 230 × 10(6). An additional 30 × 10(6) MSCs were administered 3 months later by lumbar puncture into the subarachnoid space. Outcomes were evaluated at 3, 6, 9 and 12 months after surgery through clinical, urodynamic, neurophysiological and neuroimaging studies.



Cell transplantation is a safe procedure. All patients experienced improvement, primarily in sensitivity and sphincter control. Infralesional motor activity, according to clinical and neurophysiological studies, was obtained by more than 50% of the patients. Decreases in spasms and spasticity, and improved sexual function were also common findings. Clinical improvement seems to be dose-dependent but was not influenced by the chronicity of the SCI.



Personalized cell therapy with MSCs is safe and leads to clear improvements in clinical aspects and quality of life for patients with complete and chronically established paraplegia.
Neurosurgery Service, Department of Surgery, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain; Neurological Cell Therapy Unit, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain. Electronic address: jvaqueroc@telefonica.net.
Jesús
J
Vaquero
Neurological Cell Therapy Unit, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain.
Mercedes
M
Zurita
Neurological Cell Therapy Unit, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain.
Miguel A
MA
Rico
Neurological Cell Therapy Unit, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain.
Celia
C
Bonilla
Neurological Cell Therapy Unit, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain.
Concepcion
C
Aguayo
Rehabilitation Service, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain.
Jesús
J
Montilla
Urology Service, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain.
Salvador
S
Bustamante
Urology Service, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain.
Joaquin
J
Carballido
Clinical Neurophysiology Service, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain.
Esperanza
E
Marin
Clinical Neurophysiology Service, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain.
Francisco
F
Martinez
Neurosurgery Service, Department of Surgery, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain.
Avelino
A
Parajon
Neurosurgery Service, Department of Surgery, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain.
Cecilia
C
Fernandez
Neurosurgery Service, Department of Surgery, Hospital Puerta de Hierro-Majadahonda and Autonomous University, Madrid, Spain.
Laura De
L
Reina
D000328:Adult; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D002908:Chronic Disease; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects; D059630:Mesenchymal Stem Cells / Q000166:cytology / Q000502:physiology; D008875:Middle Aged; D010264:Paraplegia / Q000175:diagnosis / Q000209:etiology / Q000473:pathology / Q000628:therapy*; D057285:Precision Medicine / Q000009:adverse effects / Q000379:methods*; D011788:Quality of Life; D013030:Spain; D013119:Spinal Cord Injuries / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D014182:Transplantation, Autologous / Q000009:adverse effects; D016896:Treatment Outcome
cell therapy; mesenchymal stromal cells; paraplegia