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

This study has been completed.
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: June 17, 2015
Last verified: November 2013
  Purpose

The purpose of this study is to confirm the security, and detect the effect of the local administration in damaged nervous tissue, of autologous bone marrow stromal cells.


Condition Intervention Phase
Spinal Cord Injury
Biological: Mesenchymal stromal cell therapy
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:
  • Safety [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

    Clinical evaluation of possible adverse effects is performed daily at the first week after the first administration of stem cells and weekly until the 6 months follow-up visit and then at month 9 and 12.

    • During the first stem cells administration (during surgery): Changes in vital signs (ECG, Blood Pressure (BP), Heart Rate (HR) were evaluated
    • During the second stem cells administration: Changes in vital signs (BP, HR), headache and meningeal irritation were evaluated
    • During the first weeks, after the first and the second administrations, the possibility of meningeal irritation, headache and infectious complications were considerate.


Secondary Outcome Measures:
  • Efficacy [ 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.



Enrollment: 12
Study Start Date: March 2013
Study Completion Date: March 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal stromal cell therapy
Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later
Biological: Mesenchymal stromal cell therapy
Other Name: BMMSCs= Bone Marrow Mesenchymal Stem 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) who were treated with autologous stromal cells of the bone marrow administrated locally (subarachnoid and intramedullar) by intrathecal microinjection and three months later, by lumbar subarachnoid administration. The minimum follow-up duration 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 American Spinal Injury Association Impairment (ASIA) Scale .
  • 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 oxaloacetate 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 the terminal portion of the spinal cord
  • Current neoplastic disease diagnosed or treated in the previous five years
  • Patients treated with hematopoietic growth factors or requiring stable anticoagulation
  • 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 According to the investigator's opinion if there are findings on physical examination, abnormal clinical test results or other medica relevant entries, social or psychosocial factors which might influence negatively the study.
  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

Locations
Spain
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
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: June 17, 2015
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Puerta de Hierro University Hospital:
neurophysiological parameters improvement
spinal cord injury
biology therapy

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

ClinicalTrials.gov processed this record on August 31, 2015