Back to resultsAdministration of Expanded Autologous Adult Bone Marrow Mesenchymal Cells in Established Chronic Spinal Cord Injuries
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Autologous Mesenchymal Bone Marrow Cell
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Adult Autologous Bone Marrow Mesenchymal Cells Expanded, chronic spinal cord injury (SCI)
Eligibility Criteria
Inclusion Criteria:
- Spinal cord injury (Level A, B, C or D in ASIA scales), clinically stable for at least 6 months prior to study start.
- Previous studies of Neurophysiology, MRI and Urology to allow useful baseline, in order that they can be compared with the same scans following treatment, and to obtain objective data of potential efficacy.
- Age between 18 and 70 years.
- Men and women of childbearing age must compromise to use contraceptives from the time at which the removal of cells from the bone marrow is performed until 6 months after the Mesenchymal Stem Cells (MSC) last administration by lumbar puncture.
- Possibility of follow up and ability to perform ambulatory physical therapy throughout all treatment period.
- Written informed consent, according to the law in force.
- Hematologic, creatinine, Serum glutamic oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) parameters, within the normal range, according to laboratory standards. However, slight modifications that are considered significant in the context of treatment to be performed, according to the criterion of the research team, are accepted.
Exclusion Criteria:
- Age below 18 years or above 70.
- Pregnancy or lactation.
- Current neoplastic disease or in the previous 5 years (diagnosed or treated).
- Patients with systemic disease that represents an added risk to treatment.
- Alterations in the genetic study performed to discard risk cell transformation in the expansion process.
- Patients with doubts about possible cooperation in the maintenance physical therapy or in the controls carried out during the study
- Neurodegenerative disease added.
- History of substance abuse, psychiatric disease or allergy to protein products used in the process of cell expansion.
- Positive serology for HIV and syphilis.
- Active Hepatitis B or Hepatitis C, according to serology analysis.
- If in the opinion of the researcher there is some other reason why the patient is not considered candidate for the study.
Sites / Locations
- Hospital Puerta de Hierro
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autologous Mesenchymal Bone Marrow Cell
Arm Description
All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow expanded Stem Cell (CME) Pharmaceutical form: Suspension in autologous plasma cell Route of administration: Intrathecal in subarachnoid space by lumbar puncture. Dose: Total dose of 300 x 106 CME, given in 3 injections of 100 x 106 CME, at intervals of 3 months between each administration.
Outcomes
Primary Outcome Measures
Changes in IANR-SCIFRS score are considerate for the motor and sensory functions evaluation.
Efficacy evaluation by measuring the change in motor and sensory functions by using the international Association of Neurorestoratology-Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS). This scale includes 9 categories with 16 items in total (plus one optional category).
The maximum possible score is 48; the lowest possible score is 0.
Secondary Outcome Measures
Neurotrophic factors levels in Cerebrospinal fluid (CSF) and/ or Number of Adverse Events related to treatment
The clinical evaluation of possible adverse effects is performed throughout the entire study duration and will be measured by descriptive analysis
Changes in PENN score are considerate for the motor and sensory functions evaluation
Efficacy evaluation by measuring the change in motor and sensory functions by using the Penn Spasm Frequency Scale that is Composed of 2-parts: the first is a self-report measure with items on 5-point scales developed to augment clinical ratings of spasticity and provides a more comprehensive assessment of spasticity
Changes in VAS score are considerate for quantification of pain
Efficacy evaluation by measuring the change in pain by using the visual analogue scale (VAS). The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks, depending on his feel of pain.
Changes in BDS score are considerate for the Assessment of the functional status
Efficacy evaluation by measuring the change in the Blepharospasm Disability Scale (BDS)
Changes in GEFFNER score are considerate for the Assessment of the functional status
Efficacy evaluation by measuring the change in the GEFFNER score
Full Information
NCT ID
NCT02570932
First Posted
October 2, 2015
Last Updated
April 3, 2018
Sponsor
Puerta de Hierro University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02570932
Brief Title
Administration of Expanded Autologous Adult Bone Marrow Mesenchymal Cells in Established Chronic Spinal Cord Injuries
Official Title
Intrathecal Administration (Pattern 100/3) of Expanded Autologous Adult Bone Marrow Mesenchymal Stem Cells in Established Chronic Spinal Cord Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 4, 2017 (Actual)
Study Completion Date
December 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Puerta de Hierro University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to analyze the potential clinical efficacy of intrathecal administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow mesenchymal stem cells in the treatment of patients with established chronic spinal cord injury (LEM).
Detailed Description
This is a clinical trial phase II, single-center, non-randomized, uncontrolled, open prospective follow-up of a cohort of patients with chronic spinal cord injury.
Patients are treated with repeated administrations of in vitro expanded autologous adult bone marrow mesenchymal stem cells.
The expanded cells are administered in the subarachnoid space by lumbar puncture. The minimum duration of the follow-up period for each patient is 10 months after the first administration.
The study duration is 24 months, that include recruiting, treatment and follow period for all patients. For each patient at the first day will be administered the first cellular doses, then 3 doses will be administrated every 3 months. At the end of the clinical trial, a completed check of all obtained parameters will be performed.
It is considered Day 1 for each patient the first day of the first cell administration. The remaining 2 doses will be administered at intervals of 3 months from the first administration (of the treatment period after, months 4 and 7). At the end of the study will be performed a full assessment of the variables collected along the study trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Adult Autologous Bone Marrow Mesenchymal Cells Expanded, chronic spinal cord injury (SCI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous Mesenchymal Bone Marrow Cell
Arm Type
Experimental
Arm Description
All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow expanded Stem Cell (CME)
Pharmaceutical form: Suspension in autologous plasma cell Route of administration: Intrathecal in subarachnoid space by lumbar puncture. Dose: Total dose of 300 x 106 CME, given in 3 injections of 100 x 106 CME, at intervals of 3 months between each administration.
Intervention Type
Biological
Intervention Name(s)
Autologous Mesenchymal Bone Marrow Cell
Intervention Description
Suspension in autologous plasma cell of Adult mesenchymal stem cells expanded autologous bone marrow.
Route of administration: Intrathecal in subarachnoid space by lumbar puncture.Total dose of 300 x 106 CME, divided in 3 injections of 100 x 106 CME, with intervals of three months between each administration
Primary Outcome Measure Information:
Title
Changes in IANR-SCIFRS score are considerate for the motor and sensory functions evaluation.
Description
Efficacy evaluation by measuring the change in motor and sensory functions by using the international Association of Neurorestoratology-Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS). This scale includes 9 categories with 16 items in total (plus one optional category).
The maximum possible score is 48; the lowest possible score is 0.
Time Frame
from baseline until the end of the follow up period (24 months)
Secondary Outcome Measure Information:
Title
Neurotrophic factors levels in Cerebrospinal fluid (CSF) and/ or Number of Adverse Events related to treatment
Description
The clinical evaluation of possible adverse effects is performed throughout the entire study duration and will be measured by descriptive analysis
Time Frame
from baseline to 24 months
Title
Changes in PENN score are considerate for the motor and sensory functions evaluation
Description
Efficacy evaluation by measuring the change in motor and sensory functions by using the Penn Spasm Frequency Scale that is Composed of 2-parts: the first is a self-report measure with items on 5-point scales developed to augment clinical ratings of spasticity and provides a more comprehensive assessment of spasticity
Time Frame
from baseline until the end of the follow up period (24 months)
Title
Changes in VAS score are considerate for quantification of pain
Description
Efficacy evaluation by measuring the change in pain by using the visual analogue scale (VAS). The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks, depending on his feel of pain.
Time Frame
from baseline until the end of the follow up period (24 months)
Title
Changes in BDS score are considerate for the Assessment of the functional status
Description
Efficacy evaluation by measuring the change in the Blepharospasm Disability Scale (BDS)
Time Frame
from baseline until the end of the follow up period (24 months)
Title
Changes in GEFFNER score are considerate for the Assessment of the functional status
Description
Efficacy evaluation by measuring the change in the GEFFNER score
Time Frame
from baseline until the end of the follow up period (24 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Spinal cord injury (Level A, B, C or D in ASIA scales), clinically stable for at least 6 months prior to study start.
Previous studies of Neurophysiology, MRI and Urology to allow useful baseline, in order that they can be compared with the same scans following treatment, and to obtain objective data of potential efficacy.
Age between 18 and 70 years.
Men and women of childbearing age must compromise to use contraceptives from the time at which the removal of cells from the bone marrow is performed until 6 months after the Mesenchymal Stem Cells (MSC) last administration by lumbar puncture.
Possibility of follow up and ability to perform ambulatory physical therapy throughout all treatment period.
Written informed consent, according to the law in force.
Hematologic, creatinine, Serum glutamic oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) parameters, within the normal range, according to laboratory standards. However, slight modifications that are considered significant in the context of treatment to be performed, according to the criterion of the research team, are accepted.
Exclusion Criteria:
Age below 18 years or above 70.
Pregnancy or lactation.
Current neoplastic disease or in the previous 5 years (diagnosed or treated).
Patients with systemic disease that represents an added risk to treatment.
Alterations in the genetic study performed to discard risk cell transformation in the expansion process.
Patients with doubts about possible cooperation in the maintenance physical therapy or in the controls carried out during the study
Neurodegenerative disease added.
History of substance abuse, psychiatric disease or allergy to protein products used in the process of cell expansion.
Positive serology for HIV and syphilis.
Active Hepatitis B or Hepatitis C, according to serology analysis.
If in the opinion of the researcher there is some other reason why the patient is not considered candidate for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesús JV Vaquero Crespo, MD.
Organizational Affiliation
Hospital Universitario Puerta de Hierro-Majadahonda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual data of participants will be shared with Authorities at the end of the Clinical development plan by the CTD (Common Technical Document). Results will be published in a scientific publication
IPD Sharing Time Frame
Starting at CTD submission to authorities.
IPD Sharing Access Criteria
Spanish competent authority.
Learn more about this trial
Administration of Expanded Autologous Adult Bone Marrow Mesenchymal Cells in Established Chronic Spinal Cord Injuries
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