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Subarachnoid Administration of Adult Autologous Bone Marrow Mesenchymal Cells Expanded in Incomplete (SCI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02165904
First Posted: June 18, 2014
Last Update Posted: June 14, 2016
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.
Information provided by (Responsible Party):
Jesús Vaquero Crespo, M.D., Puerta de Hierro University Hospital
  Purpose

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 Intervention Phase
Spinal Cord Injury Biological: Adult Autologous Mesenchymal Bone Marrow Cell Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I.Subarachnoid Administration of Adult Autologous Mesenchymal Bone Marrow Cells Expanded in Incomplete Spinal Cord Injury (SCI)

Resource links provided by NLM:


Further study details as provided by Jesús Vaquero Crespo, M.D., Puerta de Hierro University Hospital:

Primary Outcome Measures:
  • Changes in ASIA score. [ Time Frame: 24 months ]
    - Changes in ASIA score at the beginning, through and the end of the treatment.


Secondary Outcome Measures:
  • Number of Adverse Events . [ Time Frame: 24 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).

  • Change in FRANKEL score [ Time Frame: 24 months ]
    - Changes in FRANKEL, score at the beginning, through and the end of the treatment

  • Changes in NIFscore. [ Time Frame: 24 months ]
    - Changes in NIF score at the beginning, through and the end of the treatment

  • Change in Barthel score [ Time Frame: 24 months ]
    - Changes in Barthel score at the beginning, through and the end of the treatment

  • Changes in PENN score. [ Time Frame: 24 months ]
    - Changes in PENNscore at the beginning, through and the end of the treatment

  • Changes in ASHWORTH score [ Time Frame: 24 months ]
    - Changes in ASHWORTH score at the beginning, through and the end of the treatment

  • Changes in EVA score [ Time Frame: 24 months ]
    • Changes in EVA score at the beginning, through and the end of the treatment


Enrollment: 10
Study Start Date: May 2014
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.
  Contacts and Locations
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
Spain
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
  More Information

Publications:
Responsible Party: Jesús Vaquero Crespo, M.D., Principal Investigator, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT02165904     History of Changes
Other Study ID Numbers: CME-LEM2
2011-005684-24 ( Registry Identifier: 2011-005684-24 )
First Submitted: May 6, 2014
First Posted: June 18, 2014
Last Update Posted: June 14, 2016
Last Verified: June 2016
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:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries