Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury (DNH)

January 9, 2017 updated by: Ngoc Ba Nguyen, Da Nang Hospital

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Danang, Vietnam, 59000
        • Recruiting
        • Danang Hospital
        • Contact:
        • Principal Investigator:
          • Ba N Nguyen, MD
        • Sub-Investigator:
          • Lam h Nguyen, MD
        • Sub-Investigator:
          • Anh TN Pham, MD
        • Sub-Investigator:
          • Bach N Nguyen, MD
        • Sub-Investigator:
          • Tri H Le, MD
        • Sub-Investigator:
          • Phong H Tong, BSc.
        • Sub-Investigator:
          • Nam VK Le, BPharm.
        • Sub-Investigator:
          • Thanh H Le, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months from the time when patients receive the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor function
Time Frame: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation
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
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
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
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
Change on the ASIA impairment scale from the time of registration to 6 months after cell transplantation
At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ba Ngoc Nguyen, MD, Danang Hospital
  • Study Director: Yoshihisa Suzuki, MD, PhD., Kitano Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

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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