Spinal Cord InjuryPhase 1/2NCT01471613
Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
A Phase 1/2 study testing Conventional Treatment, Lithium Carbonate Tablet and Cord Blood Cell in people with Spinal Cord Injury, run by China Spinal Cord Injury Network at 1 site in China.
Trial summary
The trial is to investigate the safety and efficacy of oral lithium, intraspinal umbilical cord blood mononuclear cell transplant, and the combination in the treatment of acute and subacute spinal cord injury Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Conventional Treatment, Lithium Carbonate Tablet and Cord Blood Cell
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Jan 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- either gender and 18-65 years old;
- acute or subacute traumatic spinal cord injury (defined as SCI resulting from an exteneral non-penetrating cause that occurred within 4 weeks);
- neurological status of ASIA A;
- neurological level between C5-T11;
- MRI shows injury site is within 3 vertebral level and necrotic focus, if exist, is less than 1/3 of the spinal cord diameter;
- professional judgment determinate that subjects need a spinal decompression surgery;
- subjects able to complete neurological examination;
- subjects have voluntarily signed and dated an informed consent form.
Who cannot join
- penetration SCI such as gun-shoot, knife-cutting or SCI caused by non-traumatic conditions;
- spinal cord lesion exceeds three segments or necrotic focus with diameter larger than 1/3 of the spinal cord;
- severe complications;
- significant medical diseases or infection;
- pregnant or lactating woman, or female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study;
- unavailability of suitable umbilical cord blood cells;
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- contraindication of lithium carbonate and/or spinal decompression surgery
- subject is currently participating in another study or has been taking any investigational drug within the last 4 weeks prior to screening;
- investigator suggests that the subject would not be suitable to participate this study
Trial locations and contacts
1 site in 1 country.
China1 site
Treating Center of Spinal Cord Injury, Chinese PLA Chengdu Army Kunming General Hospital
Kunming, Yunnan, 650032
About this study
Official title: Safety and Effect of Lithium, Umbilical Cord Blood Cells and the Combination in the Treatment of Acute and Sub-acute Spinal Cord Injury : a Randomized, Double-Blinded Placebo-Controlled Clinical Trial
The trial is to investigate the safety and efficacy of oral lithium, intraspinal umbilical cord blood mononuclear cell transplant, and the combination in the treatment of acute and subacute spinal cord injury
- Conditions
- Spinal Cord Injury
- Being tested
- Conventional Treatment, Lithium Carbonate Tablet, Cord Blood Cell, Placebo
- Keywords
- spinal cord injury, umbilical cord blood cell, cell transplant, 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.
Conventional TreatmentProcedure or surgery
Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury
Lithium Carbonate TabletDrug
250mg/tablet, administrated orally for 6 weeks.
Cord Blood CellBiological
Cord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site
PlaceboOther
Placebo tablet, orally administration of placebo for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group C - Cord blood cell | Experimental | Conventional treatment, cord blood cell transplant and placebo Receives: Procedure: Conventional Treatment; Biological: Cord Blood Cell; Other: Placebo |
| Group A - Control | Placebo comparator | Conventional treatment and placebo Receives: Procedure: Conventional Treatment; Other: Placebo |
| Group B - Lithium Carbonate | Experimental | Conventional treatment and lithium carbonate Receives: Procedure: Conventional Treatment; Drug: Lithium Carbonate Tablet |
| Group D - Combination Therapy | Experimental | Conventional treatment, cell transplant and 6-weeks course of lithium carbonate Receives: Procedure: Conventional Treatment; Drug: Lithium Carbonate Tablet; Biological: Cord Blood Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in AIS Motor and sensory scores and ASIA Impairment Scales in 48 weeks
Measured: Week 0, 1, 2, 6, 14, 24 and 48
Secondary outcomes (5)
Walking
Walking Index of Spinal Cord Injury (WISCI)
Measured: Week 2, 6, 14, 24, 48
Functional assessment
Spinal Cord Injury Measure (SCIM) Score
Measured: Week 2, 6, 14, 24, 48
Locomotion
Kunming locomotor scales
Measured: Week 2, 6, 14, 24, 48
Spasticity grade
Modified Ashworth Scale
Measured: Week 2, 6, 14, 24, 48
Pain
Numerical rating scales
Measured: Week 2, 6, 14, 24, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Spinal Cord Injury Network
- Sponsor type
- Research network
- Collaborators
- Chengdu PLA General Hospital, StemCyte, Inc.
- Responsible party
- Sponsor
- Investigators
- Hui Zhu, MD, Principal investigator, Chengdu PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471613
- Sponsor's protocol ID
- CN102c
- Status last verified
- Jan 2014
- First submitted
- 12 Oct 2011
- Last updated
- 28 Jan 2014
- Results posted
- No
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 Effect of Lithium, Umbilical Cord Blood Cells and the Combination in the Treatment of Acute and Sub-acute Spinal Cord Injury : a Randomized, Double-Blinded Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01471613
- Acronym / sponsor ID
- CN102c
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, umbilical cord blood cell, cell transplant, lithium carbonate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- China Spinal Cord Injury NetworkResearch network
- Collaborators
- Chengdu PLA General Hospital, StemCyte, Inc.
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 Nov 2011 (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.
The trial is to investigate the safety and efficacy of oral lithium, intraspinal umbilical cord blood mononuclear cell transplant, and the combination in the treatment of acute and subacute spinal cord injury
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group C - Cord blood cell | Experimental | Procedure: Conventional Treatment, Biological: Cord Blood Cell, Other: PlaceboConventional treatment, cord blood cell transplant and placebo |
| Group A - Control | Placebo comparator | Procedure: Conventional Treatment, Other: PlaceboConventional treatment and placebo |
| Group B - Lithium Carbonate | Experimental | Procedure: Conventional Treatment, Drug: Lithium Carbonate TabletConventional treatment and lithium carbonate |
| Group D - Combination Therapy | Experimental | Procedure: Conventional Treatment, Drug: Lithium Carbonate Tablet, Biological: Cord Blood CellConventional treatment, cell transplant and 6-weeks course of lithium carbonate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- either gender and 18-65 years old;
- acute or subacute traumatic spinal cord injury (defined as SCI resulting from an exteneral non-penetrating cause that occurred within 4 weeks);
- neurological status of ASIA A;
- neurological level between C5-T11;
- MRI shows injury site is within 3 vertebral level and necrotic focus, if exist, is less than 1/3 of the spinal cord diameter;
Key exclusion criteria (9 listed)
- penetration SCI such as gun-shoot, knife-cutting or SCI caused by non-traumatic conditions;
- spinal cord lesion exceeds three segments or necrotic focus with diameter larger than 1/3 of the spinal cord;
- severe complications;
- significant medical diseases or infection;
- pregnant or lactating woman, or female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study;
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 |
|---|---|---|
| Conventional TreatmentConventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury | Procedure or surgery | Group A - Control, Group B - Lithium Carbonate, Group C - Cord blood cell, Group D - Combination Therapy |
| Lithium Carbonate Tablet250mg/tablet, administrated orally for 6 weeks. | Drug | Group B - Lithium Carbonate, Group D - Combination Therapy |
| Cord Blood CellCord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site | Biological | Group C - Cord blood cell, Group D - Combination Therapy |
| PlaceboPlacebo tablet, orally administration of placebo for 6 weeks | Other | Group A - Control, Group C - Cord blood cell |
Primary outcome
Change from Baseline in AIS Motor and sensory scores and ASIA Impairment Scales in 48 weeks
Time frame: Week 0, 1, 2, 6, 14, 24 and 48
5 secondary outcomes
Walking
Time frame: Week 2, 6, 14, 24, 48
Functional assessment
Time frame: Week 2, 6, 14, 24, 48
Locomotion
Time frame: Week 2, 6, 14, 24, 48
Spasticity grade
Time frame: Week 2, 6, 14, 24, 48
Pain
Time frame: Week 2, 6, 14, 24, 48
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.
Hui Zhu, MD principal investigator
Chengdu PLA General Hospital
1 site 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 Conventional Treatment, Lithium Carbonate Tablet and Cord Blood Cell in people with Spinal Cord Injury, run by China Spinal Cord Injury Network at 1 site in China.
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 8 inclusion and 9 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 1 site in China. 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. Some participants in this study may receive a placebo. 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?
Change from Baseline in AIS Motor and sensory scores and ASIA Impairment Scales in 48 weeks (time frame: Week 0, 1, 2, 6, 14, 24 and 48). 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.