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

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.
 
ClinicalTrials.gov Identifier: NCT01046786
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : January 28, 2014
Sponsor:
Collaborators:
Chinese University of Hong Kong
The University of Hong Kong
Information provided by (Responsible Party):
China Spinal Cord Injury Network

Tracking Information
First Submitted Date  ICMJE January 10, 2010
First Posted Date  ICMJE January 12, 2010
Last Update Posted Date January 28, 2014
Study Start Date  ICMJE January 2010
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
  • ASIA motor scores and sensory scores [ Time Frame: 0, 1, 2, 6 24 and 48 weeks ]
  • ASIA Impairment Scale grade [ Time Frame: 0, 1, 2, 6 24 and 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2010)
  • MRI and Diffusion Tensor Imaging of spinal cord [ Time Frame: 0, 1, 24 and 48 weeks ]
  • Spinal Cord Independence Measure (SCIM) score [ Time Frame: 0, 6, 24 and 48 weeks ]
  • Walking Index of Spinal Cord Injury (WISCI) level [ Time Frame: 0, 6, 24 and 48 weeks ]
  • Modified Ashworth Scale (MAS) of Spasticity [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ]
  • Visual Analog Scale (VAS) of pain [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
  • MRI and Diffusion Tensor Imaging of spinal cord [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ]
  • Spinal Cord Independence Measure (SCIM) score [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ]
  • Walking Index of Spinal Cord Injury (WISCI) level [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ]
  • Modified Ashworth Scale (MAS) of Spasticity [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ]
  • Visual Analog Scale (VAS) of pain [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord
Official Title  ICMJE Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Tiral
Brief Summary To investigate the feasibility, safety, efficacy and optimal dose of umbilical cord blood mononuclear cell transplant in the treatment of chronic spinal cord injuries.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2014)
8
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2010)
20
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01046786
Other Study ID Numbers  ICMJE CN102B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party China Spinal Cord Injury Network
Study Sponsor  ICMJE China Spinal Cord Injury Network
Collaborators  ICMJE
  • Chinese University of Hong Kong
  • The University of Hong Kong
Investigators  ICMJE
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
PRS Account China Spinal Cord Injury Network
Verification Date January 2014

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