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Trial record 12 of 37 for:    stem cell Spinal Cord Injury AND autologous

Administration of Expanded Autologous Adult Bone Marrow Mesenchymal Cells in Established Chronic Spinal Cord Injuries

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: NCT02570932
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jesús Vaquero Crespo, M.D., Puerta de Hierro University Hospital

Tracking Information
First Submitted Date  ICMJE October 2, 2015
First Posted Date  ICMJE October 7, 2015
Last Update Posted Date April 5, 2018
Study Start Date  ICMJE July 2015
Actual Primary Completion Date December 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2016)
Changes in IANR-SCIFRS score are considerate for the motor and sensory functions evaluation. [ Time Frame: from baseline until the end of the follow up period (24 months) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
Change in motor and sensory functions [ Time Frame: from baseline until the end of the follow up period (24 months) ]
Change in the following scale are considerate for the efficacy evaluation: the International Association of Neurorestoratology-Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS), 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, the visual analogue scale EVA, the Blepharospasm Disability Scale (BDS) and the GEFFNER scale. multiple measurements data will be collected at the end of the trial and aggregated to arrive at one reported value that will obtained by Multiple linear regression and factorial analysis.
Change History Complete list of historical versions of study NCT02570932 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
  • Neurotrophic factors levels in Cerebrospinal fluid (CSF) and/ or Number of Adverse Events related to treatment [ Time Frame: from baseline to 24 months ]
    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 [ Time Frame: from baseline until the end of the follow up period (24 months) ]
    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 [ Time Frame: from baseline until the end of the follow up period (24 months) ]
    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 [ Time Frame: from baseline until the end of the follow up period (24 months) ]
    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 [ Time Frame: from baseline until the end of the follow up period (24 months) ]
    Efficacy evaluation by measuring the change in the GEFFNER score
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
Neurotrophic factors levels in Cerebrospinal fluid (CSF) and/ or Number of Adverse Events related to treatment [ Time Frame: from baseline to 24 months ]
The clinical evaluation of possible adverse effects is performed throughout the entire study duration and will be measured by descriptive analysis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Administration of Expanded Autologous Adult Bone Marrow Mesenchymal Cells in Established Chronic Spinal Cord Injuries
Official Title  ICMJE Intrathecal Administration (Pattern 100/3) of Expanded Autologous Adult Bone Marrow Mesenchymal Stem Cells in Established Chronic Spinal Cord Injuries
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Biological: Autologous Mesenchymal Bone Marrow Cell

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

Study Arms  ICMJE Experimental: Autologous Mesenchymal Bone Marrow Cell

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: Biological: Autologous Mesenchymal Bone Marrow Cell
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 4, 2017
Actual Primary Completion Date December 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Spinal cord injury (Level A, B, C or D in ASIA scales), clinically stable for at least 6 months prior to study start.
  2. 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.
  3. Age between 18 and 70 years.
  4. 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.
  5. Possibility of follow up and ability to perform ambulatory physical therapy throughout all treatment period.
  6. Written informed consent, according to the law in force.
  7. 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:

  1. Age below 18 years or above 70.
  2. Pregnancy or lactation.
  3. Current neoplastic disease or in the previous 5 years (diagnosed or treated).
  4. Patients with systemic disease that represents an added risk to treatment.
  5. Alterations in the genetic study performed to discard risk cell transformation in the expansion process.
  6. Patients with doubts about possible cooperation in the maintenance physical therapy or in the controls carried out during the study
  7. Neurodegenerative disease added.
  8. History of substance abuse, psychiatric disease or allergy to protein products used in the process of cell expansion.
  9. Positive serology for HIV and syphilis.
  10. Active Hepatitis B or Hepatitis C, according to serology analysis.
  11. If in the opinion of the researcher there is some other reason why the patient is not considered candidate for the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02570932
Other Study ID Numbers  ICMJE CME-LEM3
2014-005613-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Time Frame: Starting at CTD submission to authorities.
Access Criteria: Spanish competent authority.
Responsible Party Jesús Vaquero Crespo, M.D., Puerta de Hierro University Hospital
Study Sponsor  ICMJE Puerta de Hierro University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jesús JV Vaquero Crespo, MD. Hospital Universitario Puerta de Hierro-Majadahonda
PRS Account Puerta de Hierro University Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP