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Trial record 32 of 56 for:    stem cell Spinal Cord Injury AND cells

Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia (CME-LEM1)

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ClinicalTrials.gov Identifier: NCT01909154
Recruitment Status : Completed
First Posted : July 26, 2013
Results First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Jesús Vaquero Crespo, M.D., Puerta de Hierro University Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Spinal Cord Injury
Intervention Biological: Mesenchymal stromal cell therapy
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mesenchymal Stromal Cell Therapy
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Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x10^6 followed by subarachnoid administration of 30x10^6 MSCs,3 months later

Mesenchymal stromal cell therapy

Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Mesenchymal Stromal Cell Therapy
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Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x10^6 followed by subarachnoid administration of 30x10^6 MSCs,3 months later

Mesenchymal stromal cell therapy

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
40.5  (8.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
3
  25.0%
Male
9
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 12 participants
12
1.Primary Outcome
Title Safety-Number of Adverse Events
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Clinical evaluation of possible adverse effects is performed daily at the first week after the first administration of stem cells and weekly until the 6 months follow-up visit and then at month 9 and 12. .

  • During the first stem cells administration (during surgery): Changes in vital signs (ECG, Blood Pressure (BP), Heart Rate (HR) were evaluated
  • During the second stem cells administration: Changes in vital signs (BP, HR), headache and meningeal irritation were evaluated
  • During the first weeks, after the first and the second administrations, the possibility of meningeal irritation, headache and infectious complications were considerate.

MedDRA stardards are followed

Time Frame Up to 12 months
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Hide Analysis Population Description
Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later
Arm/Group Title Mesenchymal Stromal Cell Therapy
Hide Arm/Group Description:

Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later

Mesenchymal stromal cell therapy

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Adverse events
69
2.Secondary Outcome
Title Efficacy-Sensitivity Recovery Using ASIA Scale
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Sensitivity recovery was measured using the ASIA (American Spinal Injury Association) scale to measure the Surface sensitivity (LTS), pain sensitivity (PPS), and the degree of motor function in key muscles (MS). The sum of MS, LTS, and PPS configure total ASIA score. A minimum possible score is 0 points. A maximum possible score is 224 points for a patient with normal sensation.

ASIA score was obtained before surgery, and 3, 6, 9 and 12 months after surgery. Mean and standard deviation for the 12 patients were obtained at all the time points and statistically analyzed.

Time Frame sensitivity before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mesenchymal Stromal Cell Therapy
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Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later

Mesenchymal stromal cell therapy

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Before Surgery 165.92  (22.83)
3 months after surgery 181.25  (22.90)
6 months after surgery 189.83  (27.83)
9 months after surgery 200.75  (34.40)
12 months after surgery 213.25  (37.19)
3.Secondary Outcome
Title Efficacy-Changes in the Level of Chronic Pain Based on the IANR-SCIFRS Scale (Pain Section)
Hide Description

Changes in the level of chronic pain, measured by the pain section of the IANR-SCIFRS (Spinal cord injury functional rating scale (SCI-FRS) of the international association of neuroestoratology (IANR). The minimum posible score is 0, and the máximum posible score is 48, being a score of 48 a normal functioning across all categories, and 0 a severe degree of functional hándicap (significant impact of daily life).

Pain is classified as no pain; mild pain, ordinary pain killer, effective;severe pain, narcotics required; extreme pain, uncontrolled.

Time Frame Changes in the level of Chronic pain before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mesenchymal Stromal Cell Therapy
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Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later

Mesenchymal stromal cell therapy

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Before Surgery 2.00  (0.95)
3 months after surgery 2.25  (0.97)
6 months after surgery 2.42  (0.90)
9 months after surgery 2.42  (0.90)
12 months after surgery 2.58  (0.79)
4.Secondary Outcome
Title Efficacy- Changes in the Neurophysiological Parameters Measured as the Number of Patients With SSEPs (Somatosensory Evoked Potentials)
Hide Description Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as number of patients WITH SSEPs, each patient through underwent neurophysiological studies before treatment, as well as six and 12 months after surgery, paying attention mainly to the presence or abscence of somatosensory evoked potentials (SSEPs), the presence or absence of motor evoked potentials (MEPs) elicited by magnetic stimulation over the scalp, and to electromyographic (EMG) recording of motor unit potentials in infralesional muscles. Previous to cell therapy in any of the patients SSEPs were recorded.
Time Frame Changes in the level neurophysiological parameters improvement (baseline visit) and 6, 12 months after surgery (follow-up period)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mesenchymal Stromal Cell Therapy
Hide Arm/Group Description:

Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later

Mesenchymal stromal cell therapy

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: number of patients with SSEPs
Before Surgery 0
6 months after surgery 5
12 months after surgery 7
5.Secondary Outcome
Title Efficacy-Urodynamic Studies in Terms of máximum Cystometric Capacity
Hide Description Urodynamic studies in terms of voluntary micturition in flowmetry or in pressure/flow test, increase in bladder compliance. detrusor pressure (decrease on detrusor pressure is considered a clinical improvement). The neurogenic bladder is one of the biggest problems associated with SCI (spinal cord injury), with important personal and social implications.
Time Frame Urodynamic studies before surgery and 12 months after surgery (follow-up period)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mesenchymal Stromal Cell Therapy
Hide Arm/Group Description:

Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later

Mesenchymal stromal cell therapy

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: cm/H2O
Before Surgery 77.50  (34.61)
12 months after surgery 54.58  (22.88)
6.Secondary Outcome
Title Efficacy-modification of Magnetic Resonance Imaging (MRI)
Hide Description Number of patients with a decrease in volume and hyperintensity of intramedullary lesions. In general, in the areas of SCI, variable degree of spinal cord atrophy and hiperintense images are observed. These images corresponds to cysts, gliosis and myelomalacia. After cell administration a reduction of supposed cyst and a decrease or disappearance of hyperintense lesions suggest a patient improvement.
Time Frame changes in the spinal cord morphology on neuroimaging studies before surgery and 12 months after surgery (follow-up period)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mesenchymal Stromal Cell Therapy
Hide Arm/Group Description:

Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later

Mesenchymal stromal cell therapy

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Patients
Before Surgery 0
12 months after surgery 7
Time Frame Along the study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mesenchymal Stromal Cell Therapy
Hide Arm/Group Description

Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x10^6 followed by subarachnoid administration of 30x10^6 MSCs,3 months later

Mesenchymal stromal cell therapy

All-Cause Mortality
Mesenchymal Stromal Cell Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mesenchymal Stromal Cell Therapy
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mesenchymal Stromal Cell Therapy
Affected / at Risk (%) # Events
Total   12/12 (100.00%)    
Blood and lymphatic system disorders   
Iron deficiency anemia  1  1/12 (8.33%)  1
Gastrointestinal disorders   
Diarrhea  1  1/12 (8.33%)  1
Nausea  1  2/12 (16.67%)  2
General disorders   
Pain  1  4/12 (33.33%)  4
Saline extravasation  1  1/12 (8.33%)  2
Local edema  1  1/12 (8.33%)  1
Hyperthermia  1  3/12 (25.00%)  5
Infections and infestations   
Perineal abscess  1  1/12 (8.33%)  1
Urinary tract infection  1  12/12 (100.00%)  24
Infectious mononucleosis  1  1/12 (8.33%)  1
Nasopharyngitis  1  2/12 (16.67%)  2
Injury, poisoning and procedural complications   
Subcutaneous seroma  1  1/12 (8.33%)  1
Metabolism and nutrition disorders   
High level of cholesterol in blood  1  1/12 (8.33%)  1
High level of alkaline phosphatase in blood  1  1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  4/12 (33.33%)  5
Thoracic pain  1  1/12 (8.33%)  1
Muscle contracture  1  2/12 (16.67%)  2
Myalgia  1  3/12 (25.00%)  3
Nervous system disorders   
Headache  1  2/12 (16.67%)  2
Intercostal nerualgia  1  1/12 (8.33%)  1
Psychiatric disorders   
Anxiety  1  1/12 (8.33%)  1
Renal and urinary disorders   
Urinary disconfort  1  1/12 (8.33%)  1
Skin and subcutaneous tissue disorders   
Pressure ulcer  1  1/12 (8.33%)  1
Surgical and medical procedures   
Hemorrhoidectomy  1  1/12 (8.33%)  1
Vascular disorders   
Hypertension  1  1/12 (8.33%)  1
Hypotension  1  1/12 (8.33%)  2
Orthostatic hypotension  1  1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Vaquero Crespo
Organization: Hospital Universitario Puerta de Hierro Majadahonda, Madrid
Phone: 91 191 7760
EMail: jesus.vaquero@salud.madrid.org
Layout table for additonal information
Responsible Party: Jesús Vaquero Crespo, M.D., Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT01909154     History of Changes
Other Study ID Numbers: CME-LEM1
2010-023285-46 ( EudraCT Number )
First Submitted: July 7, 2013
First Posted: July 26, 2013
Results First Submitted: September 27, 2016
Results First Posted: March 29, 2019
Last Update Posted: March 29, 2019