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Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02165904
Recruitment Status : Completed
First Posted : June 18, 2014
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Jesús Vaquero Crespo, M.D., Puerta de Hierro University Hospital

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.

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Study Type : Interventional  (Clinical Trial)
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 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Efficacy-Sensivity Improvement Using the ASIA Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 . [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165904


Locations
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Spain
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Sponsors and Collaborators
Puerta de Hierro University Hospital
Investigators
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Principal Investigator: Jesús JV Vaquero Crespo, M.D. Hospital Universitario Puerta de Hierro-Majadahonda
Publications:
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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 ( Registry Identifier: 2011-005684-24 )
First Posted: June 18, 2014    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Keywords provided by Jesús Vaquero Crespo, M.D., Puerta de Hierro University Hospital:
Analyze clinical efficacy of subarachnoid administration of
autologous BMSC expanded "in vitro"
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System