Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI

• Sponsor: Puerta de Hierro University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02165904
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Biological: Adult Autologous Mesenchymal Bone Marrow Cell	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in Patients Suffering Incomplete Spinal Cord Injury (SCI)
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Autologous Mesenchymal Bone Marrow Cell All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow Cell	Biological: Adult Autologous Mesenchymal Bone Marrow Cell; Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells.

Outcome Measures

Primary Outcome Measures

1. Efficacy-Sensivity Improvement Using the ASIA Score [measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery]

   Sensitivity improvement 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 10 patients were obtained at all the time points and statistically analyzed.

2. Efficacy- Changes in Functional Independence Measure Scale [measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery]

   - Changes in Functional Independence Measure scale (NIF scale), score at the beginning, through and the end of the treatment. Ranges score: 18 to 126. Being 18 total patient dependency and 126 total patient independence.

3. Efficacy-Change in Barthel Score [measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery]

   - Changes in Barthel score at the beginning, through and the end of the treatment. Ranges score: 0 to 100. Being 0 total patient dependency and 100 total patient independence.

4. Efficacy-IANC-SCIFRS Scale [Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)]

   -Changes in IANC-SCIFRS scale Ranges score: 0 to 48. Being 0 severe degree of disability and 48 normal value.

5. Efficacy-Changes in PENN Score. [measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery]

   - Changes in PENN score at the beginning, through and the end of the treatment Ranges score: 0 to 4. Being 0 absence of spasms and 4 frequency greater than 10 spasms per hour.

6. Changes in ASHWORTH Score [measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery]

   - Changes in ASHWORTH score at the beginning, through and the end of the treatment Ranges score: 0 to 4. Being 0 when there isn´t increase in muscle tone when stretching, and 4 when there is rigid affected follow-up in flexion or extension

7. Efficacy-Changes in EVA Score [measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery]

   • Changes in EVA score at the beginning, through and the end of the treatment Ranges score: 0 to 10. Being 0 absence of pain and 10 the worst pain.

8. Efficacy- Changes in Geffner Score [Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)]

   changes in Geffner score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) Ranges score: 0 to 6. Being 0 absence of bladder control and 6 total control of bladder

9. Efficacy- Changes in NBD Score [measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery]

   changes in NBD score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) Ranges score: 0 to 47. 0-6 is very minor dysfunction. 7-9 is minor dysfunction. 10-13 is moderate dysfunction; and 14 or more is severe dysfunction.

10. Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials) [Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery]

    Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as the number of patients that improved along the study.

11. Efficacy-Urodynammic in Terms of Detrusor Pressure [Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up]

    Urodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement)

12. Efficacy-Urodynamic Studies Bladder Compliance [measure before treatment (baseline visit), 6 and 12 months after surgery]

    Urodynamic studies in terms of Bladder compliance. Bladder compliance is the result of a mathematical calculation of volume responsible for 1 cm H2O pressure rise measured during a cystometric filling . It gives an indication on how the different mechanisms in the bladder wall react on stretching. It is obvious that compliance figures can vary widely in groups which makes it difficult to define limits of normality.

13. Efficacy-Urodynamic Studies Maximum Cystometric Capacity [Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up]

    Urodynamic studies in terms of Maximum cystometric capacity

14. Efficacy-modification of Magnetic Resonance Imaging (MRI) [before (baseline visit) and at 12 months]

    Number of patients with changes in morphology of injury compared with basal images

Secondary Outcome Measures

1. Number of Adverse Events . [Up to 12 months]

   - The safety will be valued with number of adverse events related with administration of subarachnoid autologous Bone Marrow Expanded Mesenchymal Cells in Incomplete Spinal Cord Injury (SCI).

2. Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples [Basal and 10 months after the administration]

   Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophins were: BDNF.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Puerta de Hierro	Majadahonda	Madrid	Spain	28222

Sponsors and Collaborators

• Puerta de Hierro University Hospital

Investigators

• Principal Investigator: Jesús JV Vaquero Crespo, M.D., Hospital Universitario Puerta de Hierro-Majadahonda

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.

• Responsible Party: Jesús Vaquero Crespo, M.D., Principal Investigator, Puerta de Hierro University Hospital
• ClinicalTrials.gov Identifier: NCT02165904
• Other Study ID Numbers: CME-LEM2; 2011-005684-24
• First Posted: Jun 18, 2014
• Last Update Posted: Jul 19, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Jesús Vaquero Crespo, M.D., Principal Investigator, Puerta de Hierro University Hospital: Analyze clinical efficacy of subarachnoid administration of; autologous BMSC expanded "in vitro"
• Additional relevant MeSH terms: Spinal Cord Injuries

Study Results

Participant Flow

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.2 (9.30)
Sex: Female, Male (Count of Participants)
Female	8 80%
Male	2 20%
Region of Enrollment (participants) [Number]
Spain	10 100%

Outcome Measures

1. Primary Outcome

Title	Efficacy-Sensivity Improvement Using the ASIA Score
Description	Sensitivity improvement 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 10 patients were obtained at all the time points and statistically analyzed.
Time Frame	measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
before surgery	188.2 (60)
3 months	202.2 (63.7)
6 months	218.4 (57.5)
9 months	228.9 (51.84)
12 months	235.5 (49.35)

2. Primary Outcome

Title	Efficacy- Changes in Functional Independence Measure Scale
Description	- Changes in Functional Independence Measure scale (NIF scale), score at the beginning, through and the end of the treatment. Ranges score: 18 to 126. Being 18 total patient dependency and 126 total patient independence.
Time Frame	measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
before surgery	95.7 (33.9)
3 months	95.7 (33.9)
6 months	95.7 (33.9)
9 months	96.10 (33.42)
12 months	98.6 (32.05)

3. Primary Outcome

Title	Efficacy-Change in Barthel Score
Description	- Changes in Barthel score at the beginning, through and the end of the treatment. Ranges score: 0 to 100. Being 0 total patient dependency and 100 total patient independence.
Time Frame	measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
before surgery	58 (36.07)
3 months	58 (36.07)
6 months	58 (36.07)
9 months	58 (36.07)
12 months	65 (35.59)

4. Primary Outcome

Title	Efficacy-IANC-SCIFRS Scale
Description	-Changes in IANC-SCIFRS scale Ranges score: 0 to 48. Being 0 severe degree of disability and 48 normal value.
Time Frame	Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
before surgery	29.10 (9.96)
3 months	31.5 (8.89)
6 months	33.90 (9.73)
9 months	35.9 (9.01)
12 months	36.9 (8.21)

5. Primary Outcome

Title	Efficacy-Changes in PENN Score.
Description	- Changes in PENN score at the beginning, through and the end of the treatment Ranges score: 0 to 4. Being 0 absence of spasms and 4 frequency greater than 10 spasms per hour.
Time Frame	measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
before surgery	1.20 (1.14)
3 months	1.10 (1.10)
6 months	0.90 (0.88)
9 months	0.90 (0.88)
12 months	0.90 (0.88)

6. Primary Outcome

Title	Changes in ASHWORTH Score
Description	- Changes in ASHWORTH score at the beginning, through and the end of the treatment Ranges score: 0 to 4. Being 0 when there isn´t increase in muscle tone when stretching, and 4 when there is rigid affected follow-up in flexion or extension
Time Frame	measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
before surgery	1.4 (0.81)
3 months	1.4 (0.81)
6 months	1.4 (0.81)
9 months	1.4 (0.81)
12 months	1.10 (0.99)

7. Primary Outcome

Title	Efficacy-Changes in EVA Score
Description	• Changes in EVA score at the beginning, through and the end of the treatment Ranges score: 0 to 10. Being 0 absence of pain and 10 the worst pain.
Time Frame	measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
before surgery	1.70 (3.13)
3 months	0.70 (1.16)
6 months	0.60 (0.97)
9 months	0.40 (0.84)
12 months	0.40 (0.84)

8. Primary Outcome

Title	Efficacy- Changes in Geffner Score
Description	changes in Geffner score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) Ranges score: 0 to 6. Being 0 absence of bladder control and 6 total control of bladder
Time Frame	Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
before surgery	3.30 (1.34)
3 months	3.60 (1.26)
6 months	3.80 (1.14)
9 months	3.90 (1.10)
12 months	4.20 (1.23)

9. Primary Outcome

Title	Efficacy- Changes in NBD Score
Description	changes in NBD score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) Ranges score: 0 to 47. 0-6 is very minor dysfunction. 7-9 is minor dysfunction. 10-13 is moderate dysfunction; and 14 or more is severe dysfunction.
Time Frame	measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
before surgery	10.60 (6.64)
3 months	6.10 (4.15)
6 months	5.70 (4.35)
9 months	4.40 (3.86)
12 months	4.20 (3.88)

10. Primary Outcome

Title	Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials)
Description	Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as the number of patients that improved along the study.
Time Frame	Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
6 months	7
12 months	8

11. Primary Outcome

Title	Efficacy-Urodynammic in Terms of Detrusor Pressure
Description	Urodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement)
Time Frame	Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
before surgery	68.6 (20.08)
6 months	53.8 (20.8)
12 months	51.5 (37.22)

12. Primary Outcome

Title	Efficacy-Urodynamic Studies Bladder Compliance
Description	Urodynamic studies in terms of Bladder compliance. Bladder compliance is the result of a mathematical calculation of volume responsible for 1 cm H2O pressure rise measured during a cystometric filling . It gives an indication on how the different mechanisms in the bladder wall react on stretching. It is obvious that compliance figures can vary widely in groups which makes it difficult to define limits of normality.
Time Frame	measure before treatment (baseline visit), 6 and 12 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
before surgery	3.88 (3.24)
6 months	6.14 (3.36)
12 months	8.28 (6.41)

13. Primary Outcome

Title	Efficacy-Urodynamic Studies Maximum Cystometric Capacity
Description	Urodynamic studies in terms of Maximum cystometric capacity
Time Frame	Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
before surgery	234.9 (156.26)
6 months	292.4 (110.93)
12 months	292.6 (183.6)

14. Primary Outcome

Title	Efficacy-modification of Magnetic Resonance Imaging (MRI)
Description	Number of patients with changes in morphology of injury compared with basal images
Time Frame	before (baseline visit) and at 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
baseline	0
12 months	0

15. Secondary Outcome

Title	Number of Adverse Events .
Description	- The safety will be valued with number of adverse events related with administration of subarachnoid autologous Bone Marrow Expanded Mesenchymal Cells in Incomplete Spinal Cord Injury (SCI).
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
Number [Adverse events]	20

16. Secondary Outcome

Title	Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples
Description	Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophins were: BDNF.
Time Frame	Basal and 10 months after the administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
Measure Participants	10
BDNF before administration	19.14 (4.58)
BDNF in month 10 after administration	33.82 (49.65)

Adverse Events

Time Frame	2 years
Arm/Group Title	Autologous Mesenchymal Bone Marrow Cell
Arm/Group Description	Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient
All Cause Mortality
	Autologous Mesenchymal Bone Marrow Cell
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Autologous Mesenchymal Bone Marrow Cell
	Affected / at Risk (%)	# Events
Total	1/10 (10%)
Respiratory, thoracic and mediastinal disorders
Bronchitis	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	Autologous Mesenchymal Bone Marrow Cell
	Affected / at Risk (%)	# Events
Total	9/10 (90%)
General disorders
Local pain	1/10 (10%)	1
Hyperthermia	1/10 (10%)	1
Infections and infestations
Urinary tract infection	2/10 (20%)	2
Infected pressure ulcer	1/10 (10%)	1
Nasopharingytis	1/10 (10%)	1
Bronchitis	1/10 (10%)	1
Injury, poisoning and procedural complications
Wound	1/10 (10%)	1
Musculoskeletal and connective tissue disorders
Leg pain	1/10 (10%)	1
Arthralgia	1/10 (10%)	1
Neck pain	1/10 (10%)	1
Back pain	1/10 (10%)	1
Nervous system disorders
Headache	3/10 (30%)	4
Syncope	1/10 (10%)	1
Pain in coccyx	1/10 (10%)	1
Renal and urinary disorders
Urinary retention	1/10 (10%)	1
Vascular disorders
Hypertension	1/10 (10%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.