Mesenchymal Stem Cells Transplantation to Patients With Spinal Cord Injury (MSC)

This study is currently recruiting participants.
Verified October 2011 by Guangzhou General Hospital of Guangzhou Military Command
Sponsor:
Information provided by:
Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT01446640
First received: October 3, 2011
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

The study is a phase I/II trial designed to establish the safety and efficacy of intravenous combined with intrathecal administration of autologous bone marrow derived mesenchymal stem cells to patients with spinal cord injury.


Condition Intervention Phase
Spinal Cord Injury
Biological: bone marrow derived mesenchymal stem cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PhaseⅠ/ⅡTrial of Autologous Bone Marrow Derived Mesenchymal Stem Cells to Patients With Spinal Cord Injury.

Resource links provided by NLM:


Further study details as provided by Guangzhou General Hospital of Guangzhou Military Command:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 1 month after transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Electromyogram and Electroneurophysiologic test [ Time Frame: 1 month after transplantation ] [ Designated as safety issue: No ]
    somatosensory and motor evoked potentials

  • Muscle strength assessment [ Time Frame: 1 month after transplantation ] [ Designated as safety issue: No ]
    Assessed by the Frankel scale.

  • Motor and sensory assessment [ Time Frame: 1 month after transplantation ] [ Designated as safety issue: No ]
    Assessed by ASIA score

  • Electromyogram and Electroneurophysiologic test [ Time Frame: 3 months after transplantation ] [ Designated as safety issue: No ]
    somatosensory and motor evoked potentials

  • Muscle strength assessment [ Time Frame: 3 months after transplantation ] [ Designated as safety issue: No ]
    Assessed by the Frankel scale.

  • Motor and sensory assessment [ Time Frame: 3 months after transplantation ] [ Designated as safety issue: No ]
    Assessed by ASIA score

  • Electromyogram and Electroneurophysiologic test [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: No ]
    somatosensory and motor evoked potentials

  • Muscle strength assessment [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: No ]
    Assessed by the Frankel scale.

  • Motor and sensory assessment [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: No ]
    Assessed by ASIA score

  • Electromyogram and Electroneurophysiologic test [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: No ]
    somatosensory and motor evoked potentials

  • Muscle strength assessment [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: No ]
    Assessed by the Frankel scale.

  • Motor and sensory assessment [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: No ]
    Assessed by ASIA score


Estimated Enrollment: 20
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MSC
Intravenous combined with intrathecal administration of autologous bone marrow derived mesenchymal stem cells to patients with spinal cord injury.
Biological: bone marrow derived mesenchymal stem cells
Intravenous administration of up to 1x10^6 MSCs per kg; intrathecal administration of up to 1x10^6 MSCs per kg.
Other Names:
  • Mesenchymal Stem Cells
  • Multipotent Mesenchymal Stem Cells
  • Multipotent Mesenchymal Stromal Cells

Detailed Description:

Spinal cord injury (SCI) is a traumatic disorder resulting in a functional deficit that usually leads to severe and permanent paralysis. Pharmacological and rehabilitation therapies to SCI get limited effect. Another promising therapeutic approaches for SCI is cellular transplantation. Cell types used in SCI therapy include Schwann cells, olfactory ensheathing cells and adult stem cells, such as neural stem cells, umbilical cord blood derived cells, mesenchymal stem cells (MSCs) or induced pluripotent stem cells. There are not yet conclusive evidences on which types of glial or adult stem cells are most effective in SCI treatment.

MSC have been shown to promote anatomical and functional recovery in animal models of SCI by promoting tissue sparing ,axonal regeneration, and remyelination. Therapeutic effects of MSCs are primarily due to the secretion of soluble factors and the provision of extracellular matrix that provide protection and support repair. MSC are attractive candidates for transplantation into human patients because they can be easily harvested, expanded and banked, or derived directly from the patient allowing for autologous transplantation, obviating the need for immune suppression.

The clinical translation of cellular transplantation strategies requires a safe and efficient means of cellular delivery. In animal models of SCI, the most common delivery is direct injection into the injury site, which allows a defined number of cells to be delivered, but risks further injuring the cord. Less invasive methods for cell delivery have been investigated, including intravascular delivery (intravenous (IV) and intra-arterial) and delivery into the cerebrospinal fluid (intrathecal). These minimally-invasive techniques decrease the risk to the patient and allow delivery of multiple cell doses. Maybe intrathecal administration is superior to IV delivery, cell engraftment and tissue sparing were significantly better after intrathecal delivery, but more researches are needed for get conclusion.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Traumatic spinal cord injury at the thoracic or lumbar level.
  • Age 16 to 60.
  • American Spinal Injury Association Impairment Scale A or B.
  • Time between injury and enrollment greater than 2 weeks and less than 1 year.
  • Patients must have organ function as defined below:

total bilirubin within normal institutional limits (NV: 0.0-20.5 umol/L); AST(SGOT)/ALT(SGPT) <2.5 × institutional upper limit of normal AST (NV: 0-35 U/L); ALT (NV: 0-40 U/L) ; Creatinine within normal institutional limits (NV: 53-106 umol/L) or Creatinine clearance >1.25 ml/s for patients with creatinine levels above institutional normal.

  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents within 4 weeks of study entry.
  • History of allergic reactions attributed to compounds of similar biologic composition to mesenchymal stem cells.
  • Primary hematologic diseases.
  • Open injuries.
  • Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent.
  • Malignancy within the last 5 years.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (defined as invasive fungal infection and progressive CMV viremia), symptomatic congestive heart failure (NYH class III and IV), unstable angina pectoris, or cardiac arrhythmia.
  • Pregnant or breastfeeding women.
  • HIV-positive patients.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446640

Contacts
Contact: Yang Xiao, MD 86-20-36653562 jdxiao111@163.com
Contact: Li Li, MD 86-20-36653562 Lily17155@yahoo.com

Locations
China, Guangdong
Guangzhou General Hospital of Guangzhou Military Command Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Yang Xiao, MD    86-20-36653562    jdxiao111@163.com   
Contact: Li Li, MD    86-20-36654678    Lily17155@yahoo.com   
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command
Investigators
Study Director: Yang Xiao, MD Guangzhou General Hospital of Guangzhou Military Command
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT01446640     History of Changes
Other Study ID Numbers: HM-2011-09
Study First Received: October 3, 2011
Last Updated: October 4, 2011
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on April 17, 2014