Phase 1
N=10
Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT02165904 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Jul 2019
Primary outcome: Primary: Efficacy-Sensivity Improvement Using the ASIA Score — 188.2; 202.2; 218.4; 228.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Adult Autologous Mesenchymal Bone Marrow Cell (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Puerta de Hierro University Hospital
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy-Sensivity Improvement Using the ASIA Score |
188.2; 202.2; 218.4; 228.9; 235.5 | — |
| PRIMARY Efficacy- Changes in Functional Independence Measure Scale |
95.7; 95.7; 95.7; 96.10; 98.6 | — |
| PRIMARY Efficacy-Change in Barthel Score |
58; 58; 58; 58; 65 | — |
| PRIMARY Efficacy-IANC-SCIFRS Scale |
29.10; 31.5; 33.90; 35.9; 36.9 | — |
| PRIMARY Efficacy-Changes in PENN Score. |
1.20; 1.10; 0.90; 0.90; 0.90 | — |
| PRIMARY Changes in ASHWORTH Score |
1.4; 1.4; 1.4; 1.4; 1.10 | — |
| PRIMARY Efficacy-Changes in EVA Score |
1.70; 0.70; 0.60; 0.40; 0.40 | — |
| PRIMARY Efficacy- Changes in Geffner Score |
3.30; 3.60; 3.80; 3.90; 4.20 | — |
| PRIMARY Efficacy- Changes in NBD Score |
10.60; 6.10; 5.70; 4.40; 4.20 | — |
| PRIMARY Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials) |
7; 8 | — |
| PRIMARY Efficacy-Urodynammic in Terms of Detrusor Pressure |
68.6; 53.8; 51.5 | — |
| PRIMARY Efficacy-Urodynamic Studies Bladder Compliance |
3.88; 6.14; 8.28 | — |
| PRIMARY Efficacy-Urodynamic Studies Maximum Cystometric Capacity |
234.9; 292.4; 292.6 | — |
| PRIMARY Efficacy-modification of Magnetic Resonance Imaging (MRI) |
0; 0 | — |
| SECONDARY Number of Adverse Events . |
20 | — |
| SECONDARY Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples |
19.14; 33.82 | — |
Summary
The study goes on 24 months, with recruiting, treatment and follow period for all patients. The first day for each patient will be the first cellular administration. 3 doses will be administrated every 3 months from first dose.
When the clinical trial finishes, it will be done a completed check of all obtained parameters.
Eligibility Criteria
Inclusion Criteria
- Incomplete SCI
- Neurological deficit clinically stable at least 12 months prior to treatment, and with a minimum of one-year evolution after SCI.
- Neurophysiological confirmation of incomplete SCI.
- The MRI study that morphologically evaluate the SCI.
- Age between 18 and 70 years
- Thread Men and women will compromise to use anticonceptive issues from first cell´s extraction to 6 months after last cell´s administration.
- Ability to attend clinical follow-up and perform physical therapy through the treatment period.
- Written and signed informed consent, according to the local regulation.
- Hematologic and creatinin parameters, SGOT and SGPT, within the normal range, according to laboratory standards considering that small variations could be accepted based on clinical study team criteria.
Exclusion Criteria
- A classification in ASIA and FRANKEL clinical scales to evaluate the SCI.
- Neurophysiological records that confirm the complete SCI.
- Age below 18 years or above 70.
- Pregnancy or lactation.
- Malignancy disease diagnosed or treated within the last 5 years.
- Patients with systemic disease that represents and additional risk to treatment.
- Patients with uncertain commitment to follow the physical therapy and clinical visits as well as patient with a negative input in the previous phycological assessment.
- Inability to assess the SCI features through MRI either noise due to spinal stabilization systems or any other cause.
- Patients currently under hematopoietic growth factors treatment or who required or maintained anticoagulation.
- Neurodegenerative disease additional.
- History of substance abuse, psychiatric disease or allergy to the protein products used in the process of cell expansion.
- Positive serology for HIV and syphilis.
- Active Hepatitis B or Hepatitis C.
- With other reason that would consider the patient ineligible for cell therapy according to the investigators judgment.
Data sourced from ClinicalTrials.gov (NCT02165904). 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.