Phase 1
N=12
Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT01909154 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Safety-Number of Adverse Events — 69 Adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Mesenchymal stromal cell therapy (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Puerta de Hierro University Hospital
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety-Number of Adverse Events |
69 | — |
| SECONDARY Efficacy-Sensitivity Recovery Using ASIA Scale |
165.92; 181.25; 189.83; 200.75; 213.25 | — |
| SECONDARY Efficacy-Changes in the Level of Chronic Pain Based on the IANR-SCIFRS Scale (Pain Section) |
2.00; 2.25; 2.42; 2.42; 2.58 | — |
| SECONDARY Efficacy- Changes in the Neurophysiological Parameters Measured as the Number of Patients With SSEPs (Somatosensory Evoked Potentials) |
0; 5; 7 | — |
| SECONDARY Efficacy-Urodynamic Studies in Terms of máximum Cystometric Capacity |
77.50; 54.58 | — |
| SECONDARY Efficacy-modification of Magnetic Resonance Imaging (MRI) |
0; 7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01909154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.