Clinical trial NCT01909154: Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia
Official title: Phase I Pilot Study to Evaluate the Security of Local Administration of Autologous Stem Cells Obtained From the Bone Marrow Stroma, in Traumatic Injuries of the Spinal Cord
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Spinal Cord Injury
Keywords: neurophysiological parameters improvement
spinal cord injury
biology therapy
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the security, and detect the effect of the local administration in damaged nervous tissue, of autologous bone marrow stromal cells.

Detailed description: It is a clinical trial phase I, single center, non-randomized, uncontrolled, open prospective follow-up of a cohort of patients with chronic spinal cord injury (SCI) who were treated with autologous stromal cells of the bone marrow administrated locally (subarachnoid and intramedullar) by intrathecal microinjection and three months later, by lumbar subarachnoid administration. The minimum follow-up duration for each patient is 12 months after the first administration, or until death, if it occurs it before.

Eligibility criteria: Inclusion Criteria:

* Male or female with ages between 18 years and 60 years with of age or older functional sequelae chronically established by traumatic injury of the spinal cord (spinal segments between the vertebral bodies C6 and L1) and considered irreversible (not respond to any other treatment). In this study, the lesion is considered chronically established, when there are no signs of functional recovery after a minimum follow-up period of 6 months after the spinal cord injury. The upper age limit is justified by the low potential of in vitro expansion of bone marrow stromal cells over 60 years.
* Complete paraplegia, with loss of motor and sensory function below the lesion (grade A in the American Spinal Injury Association Impairment (ASIA) Scale .
* Spinal injury MRI morphologically visible, and without images that suggest spinal cord transection, with separation of the both ends of the spinal cord.
* Tracking evolutionary possibility after treatment protocol and to comply physiotherapy maintained throughout the follow up period.
* Written informed Consent according to good clinical practice (GCP) and local regulations, obtained before any study procedure.
* Hematological parameters and creatinine, serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) in normal range according to laboratory standards, are accepted, however, small non-significant deviations according to the investigator.

Exclusion criteria:

* Pregnancy and lactation
* Systemic disease represents an added risk to treatment
* Patients with questions about their possible cooperation in rehabilitation-physiotherapy treatments later, or negative report psychological assessment prior.
* Neuroimaging data showing spinal cord section with separation of the terminal portion of the spinal cord
* Current neoplastic disease diagnosed or treated in the previous five years
* Patients treated with hematopoietic growth factors or requiring stable anticoagulation
* Added neurodegenerative disease
* History of substance abuse, psychiatric illness or allergy to protein products used in the process of cell expansion
* HIV positive serology and syphilis
* Hepatitis B or Hepatitis C active According to the investigator's opinion if there are findings on physical examination, abnormal clinical test results or other medica relevant entries, social or psychosocial factors which might influence negatively the study.

Primary outcomes:
measure: Safety-Number of Adverse Events
timeFrame: Up to 12 months
Secondary outcomes:
measure: Efficacy-Sensitivity Recovery Using ASIA Scale
timeFrame: sensitivity before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
measure: Efficacy-Changes in the Level of Chronic Pain Based on the IANR-SCIFRS Scale (Pain Section)
timeFrame: Changes in the level of Chronic pain before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
measure: Efficacy- Changes in the Neurophysiological Parameters Measured as the Number of Patients With SSEPs (Somatosensory Evoked Potentials)
timeFrame: Changes in the level neurophysiological parameters improvement (baseline visit) and 6, 12 months after surgery (follow-up period)
measure: Efficacy-Urodynamic Studies in Terms of máximum Cystometric Capacity
timeFrame: Urodynamic studies before surgery and 12 months after surgery (follow-up period)
measure: Efficacy-modification of Magnetic Resonance Imaging (MRI)
timeFrame: changes in the spinal cord morphology on neuroimaging studies before surgery and 12 months after surgery (follow-up period)
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
Study officials:
affiliation: Hospital Universitario Puerta de Hierro-Majadahonda
name: Jesus JV Vaquero Crespo, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geffner LF, Santacruz P, Izurieta M, Flor L, Maldonado B, Auad AH, Montenegro X, Gonzalez R, Silva F. Administration of autologous bone marrow stem cells into spinal cord injury patients via multiple routes is safe and improves their quality of life: comprehensive case studies. Cell Transplant. 2008;17(12):1277-93. doi: 10.3727/096368908787648074.