- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01046786
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Queen Mary Hospital
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Shatin, Hong Kong
- Prince of Wales Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A
Intraspinal injection of 1.6 million 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.
|
Active Comparator: Group B
Intraspinal injection of 3.2 million 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.
|
Active Comparator: Group C
Intraspinal injection of 6.4 million 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.
|
Active Comparator: Group D
Intraspinal injection of 6.4 million cord blood mononuclear cell plus 30 mg/kg methylprednisolone
|
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.
30 mg/kg 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
|
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.
30 mg/kg methylprednisolone
oral lithium, titrated to maintain 0.6-1.0 mM serum level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ASIA motor scores and sensory scores
Time Frame: 0, 1, 2, 6 24 and 48 weeks
|
0, 1, 2, 6 24 and 48 weeks
|
ASIA Impairment Scale grade
Time Frame: 0, 1, 2, 6 24 and 48 weeks
|
0, 1, 2, 6 24 and 48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MRI and Diffusion Tensor Imaging of spinal cord
Time Frame: 0, 1, 24 and 48 weeks
|
0, 1, 24 and 48 weeks
|
Spinal Cord Independence Measure (SCIM) score
Time Frame: 0, 6, 24 and 48 weeks
|
0, 6, 24 and 48 weeks
|
Walking Index of Spinal Cord Injury (WISCI) level
Time Frame: 0, 6, 24 and 48 weeks
|
0, 6, 24 and 48 weeks
|
Modified Ashworth Scale (MAS) of Spasticity
Time Frame: 0, 1, 2, 6, 24 and 48 weeks
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0, 1, 2, 6, 24 and 48 weeks
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Visual Analog Scale (VAS) of pain
Time Frame: 0, 1, 2, 6, 24 and 48 weeks
|
0, 1, 2, 6, 24 and 48 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Spinal Cord Injuries
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- CN102B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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