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Trial record 5 of 304 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

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

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ClinicalTrials.gov Identifier: NCT02923817
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : January 10, 2017
Sponsor:
Collaborators:
Kitano Hospital
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Information provided by (Responsible Party):
Ngoc Ba Nguyen, Da Nang Hospital

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Biological: Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I-II Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury
Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment Biological: Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923817


Contacts
Contact: Ba Ngoc Nguyen, MD +84905238311 ba_neurosur@yahoo.com.vn
Contact: Lam Huu Nguyen, MD +84916009802 nguyenhuulam@yahoo.com

Locations
Vietnam
Danang Hospital Recruiting
Danang, Vietnam, 59000
Contact: Ba Ngoc Nguyen, MD    +84905238311    ba_neurosur@yahoo.com.vn   
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         
Sponsors and Collaborators
Da Nang Hospital
Kitano Hospital
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Investigators
Principal Investigator: Ba Ngoc Nguyen, MD Danang Hospital
Study Director: Yoshihisa Suzuki, MD, PhD. Kitano Hospital

Responsible Party: Ngoc Ba Nguyen, Vice-director, Da Nang Hospital
ClinicalTrials.gov Identifier: NCT02923817     History of Changes
Other Study ID Numbers: DNHSCI124HP
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

Keywords provided by Ngoc Ba Nguyen, Da Nang Hospital:
spinal cord injury
autologous transplants
bone marrow derived mononuclear cells

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System