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

Primary Purpose

Spinal Cord Injuries

Status

Completed

Phase

Phase 1

Locations

Hong Kong

Study Type

Interventional

Intervention

Umbilical Cord Blood Mononuclear Cell

Methylprednisolone

Lithium

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, cord blood mononuclear cell, Methylprednisolone, Lithium Carbonate

Eligibility Criteria

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

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

Sites / Locations

Queen Mary Hospital
Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

Intraspinal injection of 1.6 million cord blood mononuclear cell

Intraspinal injection of 3.2 million cord blood mononuclear cell

Intraspinal injection of 6.4 million cord blood mononuclear cell

Intraspinal injection of 6.4 million cord blood mononuclear cell plus 30 mg/kg methylprednisolone

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

Outcomes

Primary Outcome Measures

ASIA motor scores and sensory scores

ASIA Impairment Scale grade

Secondary Outcome Measures

MRI and Diffusion Tensor Imaging of spinal cord

Spinal Cord Independence Measure (SCIM) score

Walking Index of Spinal Cord Injury (WISCI) level

Modified Ashworth Scale (MAS) of Spasticity

Visual Analog Scale (VAS) of pain

Full Information

NCT ID

NCT01046786

First Posted

January 10, 2010

Last Updated

January 27, 2014

Sponsor

China Spinal Cord Injury Network

Collaborators

Chinese University of Hong Kong, The University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT01046786

Brief Title

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

Official Title

Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Tiral

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

October 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

Chinese University of Hong Kong, The University of Hong Kong

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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, cord blood mononuclear cell, Methylprednisolone, Lithium Carbonate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

Intraspinal injection of 1.6 million cord blood mononuclear cell

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

Intraspinal injection of 3.2 million cord blood mononuclear cell

Arm Title

Group C

Arm Type

Active Comparator

Arm Description

Intraspinal injection of 6.4 million cord blood mononuclear cell

Arm Title

Group D

Arm Type

Active Comparator

Arm Description

Intraspinal injection of 6.4 million cord blood mononuclear cell plus 30 mg/kg methylprednisolone

Arm Title

Group E

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Umbilical Cord Blood Mononuclear Cell

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Intervention Description

30 mg/kg methylprednisolone

Intervention Type

Drug

Intervention Name(s)

Lithium

Intervention Description

oral lithium, titrated to maintain 0.6-1.0 mM serum level

Primary Outcome Measure Information:

Title

ASIA motor scores and sensory scores

Time Frame

0, 1, 2, 6 24 and 48 weeks

Title

ASIA Impairment Scale grade

Time Frame

0, 1, 2, 6 24 and 48 weeks

Secondary Outcome Measure Information:

Title

MRI and Diffusion Tensor Imaging of spinal cord

Time Frame

0, 1, 24 and 48 weeks

Title

Spinal Cord Independence Measure (SCIM) score

Time Frame

0, 6, 24 and 48 weeks

Title

Walking Index of Spinal Cord Injury (WISCI) level

Time Frame

0, 6, 24 and 48 weeks

Title

Modified Ashworth Scale (MAS) of Spasticity

Time Frame

0, 1, 2, 6, 24 and 48 weeks

Title

Visual Analog Scale (VAS) of pain

Time Frame

0, 1, 2, 6, 24 and 48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wai Sang Poon, MD

Organizational Affiliation

The Chinese University of Hong Kong / Prince of Wales Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gilberto Leung, MD

Organizational Affiliation

The University of Hong Kong / Queen Mary Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen Mary Hospital

City

Hong Kong

Country

Hong Kong

Facility Name

Prince of Wales Hospital

City

Shatin

Country

Hong Kong

12. IPD Sharing Statement

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

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