Clinical trial NCT02165904: Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI
Official title: Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in Patients Suffering Incomplete Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Spinal Cord Injury
Keywords: Analyze clinical efficacy of subarachnoid administration of
autologous BMSC expanded "in vitro"
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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) .10 patients will be included with this injury.

Primary objective: Analyze the possible clinical efficacy of administration of main adult mesenchymal autologous cells expanded "in vitro" in patients with incomplete and chronically established SCI.

Secondary objectives: Confirm the safety of treatment, and study possible changes in the cerebrospinal fluid (CSF) levels (Brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic factor (GDNF), nerve growth factor (NGF), ciliary neurotrophic factor (CNTF), Nerve Growth Factor 3 and 4(NT3 and NT4) after subarachnoid administration of BMMC.

Eligibility criteria: Inclusion Criteria:

1. Incomplete SCI
2. Neurological deficit clinically stable at least 12 months prior to treatment, and with a minimum of one-year evolution after SCI.
3. Neurophysiological confirmation of incomplete SCI.
4. The MRI study that morphologically evaluate the SCI.
5. Age between 18 and 70 years
6. Thread Men and women will compromise to use anticonceptive issues from first cell´s extraction to 6 months after last cell´s administration.
7. Ability to attend clinical follow-up and perform physical therapy through the treatment period.
8. Written and signed informed consent, according to the local regulation.
9. 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:

1. A classification in ASIA and FRANKEL clinical scales to evaluate the SCI.
2. Neurophysiological records that confirm the complete SCI.
3. Age below 18 years or above 70.
4. Pregnancy or lactation.
5. Malignancy disease diagnosed or treated within the last 5 years.
6. Patients with systemic disease that represents and additional risk to treatment.
7. 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.
8. Inability to assess the SCI features through MRI either noise due to spinal stabilization systems or any other cause.
9. Patients currently under hematopoietic growth factors treatment or who required or maintained anticoagulation.
10. Neurodegenerative disease additional.
11. History of substance abuse, psychiatric disease or allergy to the protein products used in the process of cell expansion.
12. Positive serology for HIV and syphilis.
13. Active Hepatitis B or Hepatitis C.
14. With other reason that would consider the patient ineligible for cell therapy according to the investigators judgment.

Primary outcomes:
measure: Efficacy-Sensivity Improvement Using the ASIA Score
timeFrame: measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery
measure: Efficacy- Changes in Functional Independence Measure Scale
timeFrame: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
measure: Efficacy-Change in Barthel Score
timeFrame: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
measure: Efficacy-IANC-SCIFRS Scale
timeFrame: Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
measure: Efficacy-Changes in PENN Score.
timeFrame: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
measure: Changes in ASHWORTH Score
timeFrame: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
measure: Efficacy-Changes in EVA Score
timeFrame: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
measure: Efficacy- Changes in Geffner Score
timeFrame: Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
measure: Efficacy- Changes in NBD Score
timeFrame: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
measure: Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials)
timeFrame: Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery
measure: Efficacy-Urodynammic in Terms of Detrusor Pressure
timeFrame: Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
measure: Efficacy-Urodynamic Studies Bladder Compliance
timeFrame: measure before treatment (baseline visit), 6 and 12 months after surgery
measure: Efficacy-Urodynamic Studies Maximum Cystometric Capacity
timeFrame: Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
measure: Efficacy-modification of Magnetic Resonance Imaging (MRI)
timeFrame: before (baseline visit) and at 12 months
Secondary outcomes:
measure: Number of Adverse Events .
timeFrame: Up to 12 months
measure: Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples
timeFrame: Basal and 10 months after the administration
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
Study officials:
affiliation: Hospital Universitario Puerta de Hierro-Majadahonda
name: Jesús JV Vaquero Crespo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaquero J, Zurita M. Functional recovery after severe CNS trauma: current perspectives for cell therapy with bone marrow stromal cells. Prog Neurobiol. 2011 Mar;93(3):341-9. doi: 10.1016/j.pneurobio.2010.12.002. Epub 2010 Dec 14.
citation: Otero L, Zurita M, Bonilla C, Aguayo C, Vela A, Rico MA, Vaquero J. Late transplantation of allogeneic bone marrow stromal cells improves neurologic deficits subsequent to intracerebral hemorrhage. Cytotherapy. 2011 May;13(5):562-71. doi: 10.3109/14653249.2010.544720. Epub 2011 Jan 5.