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Umbilical Cord Blood Mononuclear Cell Transplant to Treat Chronic Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Umbilical Cord Blood Mononuclear Cell
Methylprednisolone
Lithium Carbonate Tablet
Sponsored by
China Spinal Cord Injury Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, umbilical cord blood mononuclear cell, lithium carbonate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with chronic spinal cord injury (>12 months post-initial spinal cord injury surgery) with stable neurologic findings for at least 6 months
  • Subjects with current neurological status of ASIA A
  • The neurological level of the subjects is between C5 and T11
  • The injured site of the spinal cord is within three vertebral levels
  • Subjects must be able to read, understand, and complete the VAS
  • Subjects who have voluntarily signed and dated an informed consent form prior to any study procedures.

Exclusion Criteria:

  • Significant renal, cardiovascular, hepatic and psychiatric diseases
  • Significant medical diseases or infection
  • Pregnant or lactating woman
  • Female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study
  • The length of spinal cord lesion exceeds three segments
  • Unavailability of HLA matched umbilical cord blood cells
  • any contraindication of laminectomy operation, methylprednisolone and/or lithium carbonate
  • Subject who is currently participating in another investigational study or has been taking any investigation drug within the last 4 weeks prior to screening of the study
  • In opinion of the investigator, who suggests that the subject would not be compliant with the study protocol and/or would not be suitable to participate the study

Sites / Locations

  • Treating Center of Spinal Cord Injury, Chengdu Army Kunming General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment Group A

Treatment Group B

Treatment Group C

Treatment Group D

Treatment Group E

Arm Description

Umbilical cord blood mononuclear cell, 1.6 million

Umbilical cord blood mononuclear cell, 3.2 million

Umbilical cord blood mononuclear cell, 6.4 million

Umbilical cord blood mononuclear cell, 6.4 million; mehtylprednisolone

Umbilical cord blood mononuclear cell, 6.4 million; methylprednisolone; 6 week course of lithium carbonate tablet

Outcomes

Primary Outcome Measures

Changes from Baseline in ASIA motor and sensory scores

Secondary Outcome Measures

Spinal Cord Independence Measure (SCIM) score
Walking Index of Spinal Cord Injury (WISCI) Level
Kunming Walking Score
Modified Ashworth Scale (MAS)of spasticity
Visual Analog Scale of pain

Full Information

First Posted
February 14, 2011
Last Updated
August 20, 2014
Sponsor
China Spinal Cord Injury Network
Collaborators
Chengdu PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01354483
Brief Title
Umbilical Cord Blood Mononuclear Cell Transplant to Treat Chronic Spinal Cord Injury
Official Title
Feasibility and Safety of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Spinal Cord Injury Network
Collaborators
Chengdu PLA General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is 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. 20 patients will be randomly divided into 5 groups, 4 patient per group. The first three groups of four patients will receive transplants of increasing dose of HLA-matched umbilical cord blood mononuclear cells, starting from 4 spinal cord injection of 4µL of cell suspensions in Group A to 8µL in Group B and 16µL in Group C. If more than one subjects show neurological loss attributable to the cell injections, the trial will fall back to the previous dose. In the Group D, the highest volume of cells that do not cause neurological deficits (e.g. 16µL x4) along with a single bolus of 30 mg/kg methylprednisolone sodium succinate (MPSS) will be provided. Subjects in the Group E receive the same treatment as Group D plus a 6-week course of oral lithium carbonate. All subjects will enroll for three months intensive rehabilitation after the cell transplant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
spinal cord injury, umbilical cord blood mononuclear cell, lithium carbonate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group A
Arm Type
Experimental
Arm Description
Umbilical cord blood mononuclear cell, 1.6 million
Arm Title
Treatment Group B
Arm Type
Experimental
Arm Description
Umbilical cord blood mononuclear cell, 3.2 million
Arm Title
Treatment Group C
Arm Type
Experimental
Arm Description
Umbilical cord blood mononuclear cell, 6.4 million
Arm Title
Treatment Group D
Arm Type
Experimental
Arm Description
Umbilical cord blood mononuclear cell, 6.4 million; mehtylprednisolone
Arm Title
Treatment Group E
Arm Type
Experimental
Arm Description
Umbilical cord blood mononuclear cell, 6.4 million; methylprednisolone; 6 week course of lithium carbonate tablet
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord Blood Mononuclear Cell
Intervention Type
Biological
Intervention Name(s)
Methylprednisolone
Intervention Description
30mg/kg i.v. methylprednisolone
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate Tablet
Intervention Description
6 weeks
Primary Outcome Measure Information:
Title
Changes from Baseline in ASIA motor and sensory scores
Time Frame
Day 0, 3, Week 1, 2, 6, 14, 24, 48
Secondary Outcome Measure Information:
Title
Spinal Cord Independence Measure (SCIM) score
Time Frame
Week 0, 2, 6, 14, 24, 48
Title
Walking Index of Spinal Cord Injury (WISCI) Level
Time Frame
Week 0, 2, 6, 14, 24 and 48
Title
Kunming Walking Score
Time Frame
Week 0, 2, 6, 14, 24, 48
Title
Modified Ashworth Scale (MAS)of spasticity
Time Frame
Day 0, 3, Week 1, 2, 6, 14, 24 48
Title
Visual Analog Scale of pain
Time Frame
Day 0, 3, Week 1, 2, 6, 14, 24, 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with chronic spinal cord injury (>12 months post-initial spinal cord injury surgery) with stable neurologic findings for at least 6 months Subjects with current neurological status of ASIA A The neurological level of the subjects is between C5 and T11 The injured site of the spinal cord is within three vertebral levels Subjects must be able to read, understand, and complete the VAS Subjects who have voluntarily signed and dated an informed consent form prior to any study procedures. Exclusion Criteria: Significant renal, cardiovascular, hepatic and psychiatric diseases Significant medical diseases or infection Pregnant or lactating woman Female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study The length of spinal cord lesion exceeds three segments Unavailability of HLA matched umbilical cord blood cells any contraindication of laminectomy operation, methylprednisolone and/or lithium carbonate Subject who is currently participating in another investigational study or has been taking any investigation drug within the last 4 weeks prior to screening of the study In opinion of the investigator, who suggests that the subject would not be compliant with the study protocol and/or would not be suitable to participate the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Zhu, MD
Organizational Affiliation
Chengdu PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Treating Center of Spinal Cord Injury, Chengdu Army Kunming General Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China

12. IPD Sharing Statement

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Umbilical Cord Blood Mononuclear Cell Transplant to Treat Chronic Spinal Cord Injury

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