Clinical trial NCT02923817: Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury
Official title: Phase I-II Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury
autologous transplants
bone marrow derived mononuclear cells
Lead sponsor: Da Nang Hospital
Sponsor class: OTHER
Collaborators: name: Kitano Hospital
name: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
First posted: 2016-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with spinal cord injuries classified as A-B on the ASIA impairment scale
2. Patients injured 3 weeks to 1 year previously
3. Patients with partial spinal cord injury demonstrated by diagnostic imaging
4. Patients aged between 20 and 60 years at the acquisition of informed consent
5. Patients who submitted written informed consent by themselves

Exclusion Criteria:

1. Patients with a completely transected spinal cord
2. Patients with central spinal cord injury
3. Patients with organ failure with SOFA score of 3 points or higher
4. Patients in whom hepatitis B, hepatitis C, human immunodeficiency virus infection, or leukemia infection cannot be denied
5. Patients with malignant tumour or a history of malignant tumour within 5 years
6. Patients with following disease/disorder:

   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
7. Patients who are participating in other clinical trials or who completed participation within 6 months
8. Patients who are pregnant or possibly pregnant
9. Other patients who are judged to be ineligible by investigators

Primary outcomes:
measure: Safety profile and adverse effects of the procedure
timeFrame: 6 months from the time when patients receive the treatment
Secondary outcomes:
measure: Motor function
timeFrame: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation
measure: Sensory function
timeFrame: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation
measure: ASIA Impairment Scale
timeFrame: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation
Other outcomes:
Locations:
city: Danang
country: Vietnam
facility: Danang Hospital
Study officials:
affiliation: Danang Hospital
name: Ba Ngoc Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kitano Hospital
name: Yoshihisa Suzuki, MD, PhD.
role: STUDY_DIRECTOR
References: