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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Puerta de Hierro University Hospital
Sponsor:
Information provided by (Responsible Party):
Jesús Vaquero Crespo, M.D., Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier:
NCT01909154
First received: July 7, 2013
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

The objective of the study is confirm the security, and detecting effect of the local administration in damaged nervous tissue, of autologous bone marrow stromal cells. After one year of evolution after starting the treatment, it is possible to have efficacy data of this treatment, either in some kind of improvement in their paralysis or some kind of aspects such as sphincter control, improvement of spasms, pain or any other symptoms you may have as a result of spinal cord injury. However the principal objective of this study is to ensure that the treatment is applied is well tolerated and without complications, as experience with the techniques of cell therapy in humans is currently very limited and specific treatment protocol that will be applied, has not yet been tested in patients.


Condition Intervention Phase
Spinal Cord Injury
Other: Cells.
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Pilot Study to Evaluate the Security of Local Administration of Autologous Stem Cells Obtained From the Bone Marrow Stroma, in Traumatic Injuries of the Spinal Cord

Resource links provided by NLM:


Further study details as provided by Puerta de Hierro University Hospital:

Primary Outcome Measures:
  • Appearance of adverse effects [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

    The principal variable will be the appearance of adverse effects during administration and during the follow up period:

    On a daily Bases: The first week after first administration of CME. Weekly: Until the second administration of CME After second administration of CME it will be done a weekly clinical assessment and during months 9 and 12 of the follow-up period.



Secondary Outcome Measures:
  • Sensitivity recovery [ Time Frame: sensitivity recovery during Follow-up period: 3, 6, 9 and 12 months and the baseline visit. ] [ Designated as safety issue: No ]

    Sensitivity recovery, changes in the level of chronic pain, neurophysiological parameters improvement, and changes in the spinal cord morphology on neuroimaging studies.

    Sensitive recovery: Follow-up period: 3, 6, 9 and 12 months and the baseline visit.


  • Motor recovery [ Time Frame: Motor recovery during administration and during the follow up period: Follow-up period: 3,6,9, and 12 months and baseline visit. ] [ Designated as safety issue: No ]

    Motor recovery, changes in the level of chronic pain, neurophysiological parameters improvement, and changes in the spinal cord morphology on neuroimaging studies.

    Motor recovery: Follow-up period: 3,6,9, and 12 months and baseline visit.



Estimated Enrollment: 12
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cells
Depending on centromedullary post-traumatically injury (minimum dose of100x106 CME on a first intermedular and subarachnoid administration and then subarachnoid administration of 30x106CME,3 months later)
Other: Cells.
Depending on centromedullary , post traumatically injury (minimum dose 100x106 CME on first intermedular and subarachnoid administration,and then subarachnoid administration of 30x106 CME, 3 months later)
Other Name: Autologous cells from the bone marrow stroma

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) stablished who were administered autologous stromal cells of the bone marrow. Expanded cells will be administrated locally intrathecal (subarachnoid and intramedullary) by microinjection and three months later, by lumbar subarachnoid administration. The minimum follow-up time for each patient is 12 months after the first administration, or until death, if it occurs it before.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female with ages between 18 years and 60 years with of age or older functional sequelae chronically established by traumatic injury of the spinal cord (spinal segments between the vertebral bodies C6 and L1) and considered irreversible (not respond to any other treatment). In this study, the lesion is considered chronically established, when there are no signs of functional recovery after a minimum follow-up period of 6 months after the spinal cord injury. The upper age limit is justified by the low potential of in vitro expansion of bone marrow stromal cells over 60 years.
  • Complete paraplegia, with loss of motor and sensory function below the lesion (grade A in the scale ASIA).
  • Spinal injury MRI morphologically visible, and without images that suggest spinal cord transection, with separation of the both ends of the spinal cord.
  • Tracking evolutionary possibility after treatment protocol and to comply physiotherapy maintained throughout the follow up period.
  • Written informed Consent according to good clinical practice (GCP) and local regulations, obtained before any study procedure.
  • Hematological parameters and creatinine, serum glutamate oxalacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) in normal range according to laboratory standards, are accepted, however, small non significant deviations according to the investigator.

Exclusion criteria:

  • Pregnancy and lactation
  • Systemic disease represents an added risk to treatment
  • Patients with questions about their possible cooperation in rehabilitation-physiotherapy treatments later, or negative report psychological assessment prior.
  • Neuroimaging data showing spinal cord section with separation of ends, of the spinal cord
  • Current neoplastic disease diagnosed or treated in the previous five years
  • Patients treated with hematopoietic growth factors or requiring anticoagulation maintained
  • Added neurodegenerative disease
  • History of substance abuse, psychiatric illness or allergy to protein products used in the process of cell expansion
  • HIV positive serology and syphilis
  • Hepatitis B or Hepatitis C active If according to the opinion of investigator there are findings on physical examination, abnormal clinical test results or other medical, social or psychosocial factors which might adversely affect.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01909154

Contacts
Contact: Jesús JV Vaquero crespo, Neurosurgeon +34 911916000 jvaqueroc@telefonica.net
Contact: Mercedes MZ Zurita Castillo, Biologist +34 911916000 mzurita.hpth@salud.madrid.org

Locations
Spain
Hospital Puerta de Hierro Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Jesús JV Vaquero Crespo, Neurosurgeon    +34 911916000    jvaqueroc@telefonica.net   
Contact: Mercedes MZ Zurita Castillo, Biologist    +34 911916000    mzurita.hpth@salud.madrid.org   
Sponsors and Collaborators
Puerta de Hierro University Hospital
Investigators
Principal Investigator: Jesus JV Vaquero Crespo, Dr. Hospital Universitario Puerta de Hierro-Majadahonda
  More Information

Publications:
Responsible Party: Jesús Vaquero Crespo, M.D., Doctor on neurosurgery, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT01909154     History of Changes
Other Study ID Numbers: CME-LEM1, 2010-023285-46
Study First Received: July 7, 2013
Last Updated: November 26, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Puerta de Hierro University Hospital:
Functional recovery
Neurophysiological parameters improvement

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014