Spinal Cord InjuriesPhase 1/2NCT01046786
Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord
A Phase 1/2 study testing Umbilical Cord Blood Mononuclear Cell, Methylprednisolone and Lithium in people with Spinal Cord Injuries, run by China Spinal Cord Injury Network at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Umbilical Cord Blood Mononuclear Cell, Methylprednisolone and Lithium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesHong Kong
- Study dates
- Jan 2010to Dec 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Prince of Wales Hospital
Shatin
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Umbilical Cord Blood Mononuclear Cell, Methylprednisolone, Lithium
- Keywords
- spinal cord injury, cord blood mononuclear cell, Methylprednisolone, Lithium Carbonate
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Blood Mononuclear CellBiological
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
LithiumDrug
oral lithium, titrated to maintain 0.6-1.0 mM serum level
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Intraspinal injection of 1.6 million cord blood mononuclear cell Receives: Biological: Umbilical Cord Blood Mononuclear Cell |
| Group B | Active comparator | Intraspinal injection of 3.2 million cord blood mononuclear cell Receives: Biological: Umbilical Cord Blood Mononuclear Cell |
| Group C | Active comparator | Intraspinal injection of 6.4 million cord blood mononuclear cell Receives: Biological: Umbilical Cord Blood Mononuclear Cell |
| Group D | Active comparator | Intraspinal injection of 6.4 million cord blood mononuclear cell plus 30 mg/kg methylprednisolone Receives: Biological: Umbilical Cord Blood Mononuclear Cell; Drug: Methylprednisolone |
| Group E | Active comparator | 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 Receives: Biological: Umbilical Cord Blood Mononuclear Cell; Drug: Methylprednisolone; Drug: Lithium |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASIA motor scores and sensory scores
Measured: 0, 1, 2, 6 24 and 48 weeks
ASIA Impairment Scale grade
Measured: 0, 1, 2, 6 24 and 48 weeks
Secondary outcomes (5)
MRI and Diffusion Tensor Imaging of spinal cord
Measured: 0, 1, 24 and 48 weeks
Spinal Cord Independence Measure (SCIM) score
Measured: 0, 6, 24 and 48 weeks
Walking Index of Spinal Cord Injury (WISCI) level
Measured: 0, 6, 24 and 48 weeks
Modified Ashworth Scale (MAS) of Spasticity
Measured: 0, 1, 2, 6, 24 and 48 weeks
Visual Analog Scale (VAS) of pain
Measured: 0, 1, 2, 6, 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Spinal Cord Injury Network
- Sponsor type
- Research network
- Collaborators
- Chinese University of Hong Kong, The University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Wai Sang Poon, MD, Principal investigator, The Chinese University of Hong Kong / Prince of Wales HospitalGilberto Leung, MD, Principal investigator, The University of Hong Kong / Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046786
- Sponsor's protocol ID
- CN102B
- Status last verified
- Jan 2014
- First submitted
- 10 Jan 2010
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Tiral
- ClinicalTrials.gov ID
- NCT01046786
- Acronym / sponsor ID
- CN102B
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injury, cord blood mononuclear cell, Methylprednisolone, Lithium Carbonate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- China Spinal Cord Injury NetworkResearch network
- Collaborators
- Chinese University of Hong Kong, The University of Hong Kong
- Study start
- Jan 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Biological: Umbilical Cord Blood Mononuclear CellIntraspinal injection of 1.6 million cord blood mononuclear cell |
| Group B | Active comparator | Biological: Umbilical Cord Blood Mononuclear CellIntraspinal injection of 3.2 million cord blood mononuclear cell |
| Group C | Active comparator | Biological: Umbilical Cord Blood Mononuclear CellIntraspinal injection of 6.4 million cord blood mononuclear cell |
| Group D | Active comparator | Biological: Umbilical Cord Blood Mononuclear Cell, Drug: MethylprednisoloneIntraspinal injection of 6.4 million cord blood mononuclear cell plus 30 mg/kg methylprednisolone |
| Group E | Active comparator | Biological: Umbilical Cord Blood Mononuclear Cell, Drug: Methylprednisolone, Drug: LithiumIntraspinal 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord Blood Mononuclear CellThe 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. | Biological | Group A, Group B, Group C, Group D, Group E |
| Methylprednisolone30 mg/kg methylprednisolone | Drug | Group D, Group E |
| Lithiumoral lithium, titrated to maintain 0.6-1.0 mM serum level | Drug | Group E |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai Sang Poon, MD principal investigator
The Chinese University of Hong Kong / Prince of Wales Hospital
Gilberto Leung, MD principal investigator
The University of Hong Kong / Queen Mary Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Umbilical Cord Blood Mononuclear Cell, Methylprednisolone and Lithium in people with Spinal Cord Injuries, run by China Spinal Cord Injury Network at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASIA motor scores and sensory scores (time frame: 0, 1, 2, 6 24 and 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.