Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord

This study has been completed.
Sponsor:
Collaborators:
Chinese University of Hong Kong
The University of Hong Kong
Information provided by (Responsible Party):
China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:
NCT01046786
First received: January 10, 2010
Last updated: January 27, 2014
Last verified: January 2014

January 10, 2010
January 27, 2014
January 2010
October 2013   (final data collection date for primary outcome measure)
  • ASIA motor scores and sensory scores [ Time Frame: 0, 1, 2, 6 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • ASIA Impairment Scale grade [ Time Frame: 0, 1, 2, 6 24 and 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01046786 on ClinicalTrials.gov Archive Site
  • MRI and Diffusion Tensor Imaging of spinal cord [ Time Frame: 0, 1, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Spinal Cord Independence Measure (SCIM) score [ Time Frame: 0, 6, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Walking Index of Spinal Cord Injury (WISCI) level [ Time Frame: 0, 6, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Modified Ashworth Scale (MAS) of Spasticity [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Visual Analog Scale (VAS) of pain [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • MRI and Diffusion Tensor Imaging of spinal cord [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Spinal Cord Independence Measure (SCIM) score [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Walking Index of Spinal Cord Injury (WISCI) level [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Modified Ashworth Scale (MAS) of Spasticity [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Visual Analog Scale (VAS) of pain [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord
Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Tiral

To investigate the feasibility, safety, efficacy and optimal dose of umbilical cord blood mononuclear cell transplant in the treatment of chronic spinal cord injuries.

This is an open-label, dose-escalating clinical trial. Three groups of four patients will receive transplants of increasing doses of HLA-matched umbilical cord blood mononuclear cell into the spinal cord. In the fourth group, we will transplant the highest volume of cells that did not increase neurological deficits along with a single bolus of 30mg/kg methylprednisolone sodium succinate. In the fifth group of four subjects, we will inject that volume of cells plus a bolus intravenous dose of 30mg/kg methylprednisolone sodium succinate and a 6-week course of oral lithium carbonate titrated to 0.6-1.0 mM serum levels. All the subjects are encouraged to stand or walk for one hour a day after the cell transplantation.

The neurological and walking outcomes will be assessed 1, 2, 6, 24 and 48 weeks after transplantation. The outcomes of the five treatment groups will be compared by analysis of variance and, if possible, correlation with cell dose. Efficacy and safety will be analyzed comparing neurological change scores amongst the five different treatment groups. Loss of motor (>5 points) or sensor scores (>2 points) from baseline pre-treatment levels would be considered deleterious. Increases in scores above baseline would be considered beneficial.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Cord Injuries
  • Biological: Umbilical Cord Blood Mononuclear Cell
    The cord blood mononuclear cells are obtained from thawed units of HLA-matched human umbilical cord blood. The cells will be slowly injected into the posterior gray matter after laminectomy and opening of the dura.
  • Drug: Methylprednisolone
    30 mg/kg methylprednisolone
  • Drug: Lithium
    oral lithium, titrated to maintain 0.6-1.0 mM serum level
  • Active Comparator: Group A
    Intraspinal injection of 1.6 million cord blood mononuclear cell
    Intervention: Biological: Umbilical Cord Blood Mononuclear Cell
  • Active Comparator: Group B
    Intraspinal injection of 3.2 million cord blood mononuclear cell
    Intervention: Biological: Umbilical Cord Blood Mononuclear Cell
  • Active Comparator: Group C
    Intraspinal injection of 6.4 million cord blood mononuclear cell
    Intervention: Biological: Umbilical Cord Blood Mononuclear Cell
  • Active Comparator: Group D
    Intraspinal injection of 6.4 million cord blood mononuclear cell plus 30 mg/kg methylprednisolone
    Interventions:
    • Biological: Umbilical Cord Blood Mononuclear Cell
    • Drug: Methylprednisolone
  • Active Comparator: Group E
    Intraspinal injection of 6.4 million cord blood mononuclear cell plus 30 mg/kg methylprednisolone plus 6 week course of oral lithium, titrated to maintain 0.6-1.0 mM serum level
    Interventions:
    • Biological: Umbilical Cord Blood Mononuclear Cell
    • Drug: Methylprednisolone
    • Drug: Lithium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
December 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects of either gender and 18-60 years old
  • Subjects with chronic spinal cord injury (defined as ≧12 months post-initial SCI surgery) with stable neurological findings for at least 6 months
  • Subject with a current neurological status of ASIA A
  • The neurological level of the subjects is between C5 and T11
  • The MRI shows that the injured site of the spinal cord is within three vertebral levels and there is no cyst
  • Subjects must be able to read, understand, and complete the Visual Analog Scale
  • Subjects who have voluntarily signed and dated an informed consent form, approved by the appropriate IRB, prior to any study-specific procedures

Exclusion Criteria:

  • Significant renal, cardiovascular, hepatic and psychiatric diseases
  • Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)
  • Pregnant or lactating woman
  • Female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study
  • The MRI shows that the length of spinal cord lesion exceeds three segments or there is cyst in the spinal cord
  • The lesion edge of the spinal cord cannot be determined by imaging technology
  • Unavailability of HLA matched umbilical cord blood cells
  • Any contraindication of laminectomy operation, MPSS and/or lithium carbonate
  • Subject who is currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study and finally
  • Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and/or would not be suitable to participant this study
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT01046786
CN102B
Yes
China Spinal Cord Injury Network
China Spinal Cord Injury Network
  • Chinese University of Hong Kong
  • The University of Hong Kong
Principal Investigator: Wai Sang Poon, MD The Chinese University of Hong Kong / Prince of Wales Hospital
Principal Investigator: Gilberto Leung, MD The University of Hong Kong / Queen Mary Hospital
China Spinal Cord Injury Network
January 2014

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