NCT02923817

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

October 3, 2016

Last Update Submit

January 9, 2017

Conditions

Spinal Cord Injuries

Keywords

spinal cord injuryautologous transplantsbone marrow derived mononuclear cells

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months from the time when patients receive the treatment

Secondary Outcomes (3)

  • Motor function

    At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation

  • Sensory function

    At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation

  • ASIA Impairment Scale

    At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation

Study Arms (1)

Treatment

EXPERIMENTAL
Biological: Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection

Interventions

Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injectionBIOLOGICAL
Treatment

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danang Hospital

Da Nang, Da Nang City, 59000, Vietnam

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Ba Ngoc Nguyen, MD

    Danang Hospital

    PRINCIPAL INVESTIGATOR

  • Yoshihisa Suzuki, MD, PhD.

    Kitano Hospital

    STUDY DIRECTOR

Central Study Contacts

Ba Ngoc Nguyen, MD

CONTACT

+84905238311ba_neurosur@yahoo.com.vn

Lam Huu Nguyen, MD

CONTACT

+84916009802nguyenhuulam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-director

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 5, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

VN(1)