Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Intervention: Mesenchymal stromal cell therapy
Intervention description: Stem cells administration locally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: neurophysiological parameters improvement; spinal cord injury; biology therapy

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.
    

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.