Spinal Cord InjuriesPhase 2DNHNCT02923817
Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury
A Phase 2 study testing Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection in people with Spinal Cord Injuries, run by Da Nang Hospital at 1 site in Vietnam.
Trial summary
The purpose of study is to determine whether autologous mononuclear cells deriving from the bone marrow are effective in the treatment of spinal cord injury. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteVietnam
- Study dates
- Sep 2016to Jun 2019
- Phase
- Phase 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with spinal cord injuries classified as A-B on the ASIA impairment scale
- Patients injured 3 weeks to 1 year previously
- Patients with partial spinal cord injury demonstrated by diagnostic imaging
- Patients aged between 20 and 60 years at the acquisition of informed consent
- Patients who submitted written informed consent by themselves
Who cannot join
- Patients with a completely transected spinal cord
- Patients with central spinal cord injury
- Patients with organ failure with SOFA score of 3 points or higher
- Patients in whom hepatitis B, hepatitis C, human immunodeficiency virus infection, or leukemia infection cannot be denied
- Patients with malignant tumour or a history of malignant tumour within 5 years
- Patients with following disease/disorder:
Show all 10Show fewer
- Myeloproliferative disorder or myelodysplastic syndrome Poorly controlled ischemic heart disease Autoimmune disease Spinal stenosis Limb paralysis due to central nervous system disorder not attributed to spinal cord injury Hepatic dysfunction Renal dysfunction Poorly controlled psychiatric disorder Complex multiple trauma
- Patients who are participating in other clinical trials or who completed participation within 6 months
- Patients who are pregnant or possibly pregnant
- Other patients who are judged to be ineligible by investigators
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Danang Hospital
Da Nang, Da Nang City, 59000
Ba Ngoc Nguyen, MD, +84905238311, ba_neurosur@yahoo.com.vn
Ba N Nguyen, MD
About this study
Official title: Phase I-II Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury
The purpose of study is to determine whether autologous mononuclear cells deriving from the bone marrow are effective in the treatment of spinal cord injury.
Read the detailed description
Recruitment process:
The investigators selects the candidate of the study that fulfill the inclusion criteria and not violate any exclusion criteria from patients with spinal cord injury that admitted to the department of neurosurgery - Danang hospital. The investigators then ask the patients and patients family for informed consent. The patients that submit the informed consent to participate is recruited to the study.
Procedure description:
The patients is moved to operation theater at the day of the procedure. The bone marrow of the patients is harvested by two investigators. The mononuclear cells of the bone marrow is extracted from the bone marrow by using gravity centrifugation with Ficoll Paque 1.073. The mononuclear cells is transferred to 5 mL syringe and handed back to the investigator. The investigator will transplant the whole cell preparation back to the patients by lumbar injection.
A final supernatant layer of the preparation is also sent to the lab for microbiological and endotoxin testings. One small portion of the cell preparation is sent to the laboratory for cell count and cluster of distribution tests.
The patient is transferred back to the patient room and monitor for the outcomes at 2 weeks, 4 weeks, 2 months, 4 months, 6 months. All of the data is entered, stored and monitored via the eCB database system of TRI Cente, Kobe.
Data Analysis:
Primary Endpoint:
A list is prepared for each subject with the name of AE developed, its severity and seriousness, causal relationship with the treatment, and outcome. In addition, the incidence of AEs in all cases and the 95% confidence interval are estimated. For each AE type, the incidence, incidence by severity, and incidence by seriousness are calculated in addition to estimation of the rate of each AE and its 95% confidence interval in all cases.
Secondary Endpoint:
Regarding secondary endpoints, the Wilcoxon signed rank test is used to compare the baseline value at registration and value at 6 months after cell transplantation. In addition, assuming the scores in each secondary endpoint to be consecutive scores, a linear mixed model with time point as a fixed effect and cases as random effects is fitted to the data at registration and 2 and 6 months after cell transplantation after assuming an appropriate covariance structure between time points to assess their chronological changes.
- Conditions
- Spinal Cord Injuries
- Being tested
- Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection
- Keywords
- spinal cord injury, autologous transplants, bone marrow derived mononuclear cells
- 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.
Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injectionBiological
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Biological: Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile and adverse effects of the procedure
Causal relationship, incidence, severity, and seriousness of all adverse events (AEs) experienced following cell transplantation up to the day of the final observation are assessed.
Measured: 6 months from the time when patients receive the treatment
Secondary outcomes (3)
Motor function
Motor function score in the neurological classification of spinal cord injury: Amount of change from the time of registration to 6 months after cell transplantation
Measured: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation
Sensory function
Sensory function score in the neurological classification of spinal cord injury (light touch sensation score + pinprick sensation score): Amount of change from the time of registration to 6 months after cell transplantation
Measured: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation
ASIA Impairment Scale
Change on the ASIA impairment scale from the time of registration to 6 months after cell transplantation
Measured: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Da Nang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kitano Hospital, Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Responsible party
- Principal investigator, Ngoc Ba Nguyen, Da Nang Hospital
- Investigators
- Ba Ngoc Nguyen, MD, Principal investigator, Danang HospitalYoshihisa Suzuki, MD, PhD., Study director, Kitano Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923817
- Sponsor's protocol ID
- DNHSCI124HP
- Acronym
- DNH
- Status last verified
- Jan 2017
- First submitted
- 3 Oct 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02923817
- Acronym / sponsor ID
- DNH / DNHSCI124HP
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injury, autologous transplants, bone marrow derived mononuclear cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Da Nang HospitalUniversity, hospital or other
- Collaborators
- Kitano Hospital, Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Study start
- Sep 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 5 Oct 2016 (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 purpose of study is to determine whether autologous mononuclear cells deriving from the bone marrow are effective in the treatment of spinal cord injury.
Detailed description
Recruitment process:
The investigators selects the candidate of the study that fulfill the inclusion criteria and not violate any exclusion criteria from patients with spinal cord injury that admitted to the department of neurosurgery - Danang hospital. The investigators then ask the patients and patients family for informed consent. The patients that submit the informed consent to participate is recruited to the study.
Procedure description:
The patients is moved to operation theater at the day of the procedure. The bone marrow of the patients is harvested by two investigators. The mononuclear cells of the bone marrow is extracted from the bone marrow by using gravity centrifugation with Ficoll Paque 1.073. The mononuclear cells is transferred to 5 mL syringe and handed back to the investigator. The investigator will transplant the whole cell preparation back to the patients by lumbar injection.
A final supernatant layer of the preparation is also sent to the lab for microbiological and endotoxin testings. One small portion of the cell preparation is sent to the laboratory for cell count and cluster of distribution tests.
The patient is transferred back to the patient room and monitor for the outcomes at 2 weeks, 4 weeks, 2 months, 4 months, 6 months. All of the data is entered, stored and monitored via the eCB database system of TRI Cente, Kobe.
Data Analysis:
Primary Endpoint:
A list is prepared for each subject with the name of AE developed, its severity and seriousness, causal relationship with the treatment, and outcome. In addition, the incidence of AEs in all cases and the 95% confidence interval are estimated. For each AE type, the incidence, incidence by severity, and incidence by seriousness are calculated in addition to estimation of the rate of each AE and its 95% confidence interval in all cases.
Secondary Endpoint:
Regarding secondary endpoints, the Wilcoxon signed rank test is used to compare the baseline value at registration and value at 6 months after cell transplantation. In addition, assuming the scores in each secondary endpoint to be consecutive scores, a linear mixed model with time point as a fixed effect and cases as random effects is fitted to the data at registration and 2 and 6 months after cell transplantation after assuming an appropriate covariance structure between time points to assess their chronological changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with spinal cord injuries classified as A-B on the ASIA impairment scale
- Patients injured 3 weeks to 1 year previously
- Patients with partial spinal cord injury demonstrated by diagnostic imaging
- Patients aged between 20 and 60 years at the acquisition of informed consent
- Patients who submitted written informed consent by themselves
Key exclusion criteria (10 listed)
- Patients with a completely transected spinal cord
- Patients with central spinal cord injury
- Patients with organ failure with SOFA score of 3 points or higher
- Patients in whom hepatitis B, hepatitis C, human immunodeficiency virus infection, or leukemia infection cannot be denied
- Patients with malignant tumour or a history of malignant tumour within 5 years
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 |
|---|---|---|
| Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection | Biological | Treatment |
Primary outcome
Safety profile and adverse effects of the procedure
Time frame: 6 months from the time when patients receive the treatment
Causal relationship, incidence, severity, and seriousness of all adverse events (AEs) experienced following cell transplantation up to the day of the final observation are assessed.
3 secondary outcomes
Motor function
Time frame: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation
Sensory function
Time frame: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation
ASIA Impairment Scale
Time frame: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
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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.
Ba Ngoc Nguyen, MD principal investigator
Danang Hospital
Yoshihisa Suzuki, MD, PhD. study director
Kitano Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection in people with Spinal Cord Injuries, run by Da Nang Hospital at 1 site in Vietnam.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Jan 2017. 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 Vietnam. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ba Ngoc Nguyen, MD (+84905238311, ba_neurosur@yahoo.com.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profile and adverse effects of the procedure (time frame: 6 months from the time when patients receive the treatment). 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 10 Jan 2017.