NCT02152657

Brief Summary

The purpose of this study is to analyze the safety and efficacy of mesenchymal stem cell transplantation through percutaneous injection in patients with chronic spinal cord injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 20, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

11 months

First QC Date

May 20, 2014

Last Update Submit

April 25, 2017

Conditions

Spinal Cord Injury

Keywords

Spinal cord injuryStem cell transplantationMesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

  • Magnetic resonance imaging

    After the transplantation of the cells, patients will be followed up by clinical examinations and will perform laboratorial and radiological exams, in order to search for complications of the procedure.

    Six months

Secondary Outcomes (3)

  • Sensitivity and motor strength on the inferior limbs

    Six months

  • Improvement in urological function

    Six months

  • Improvements in sensorial mapping and neuropathic pain

    Six months

Study Arms (1)

Mesenchymal stem cell transplantation

EXPERIMENTAL
Other: Mesenchymal stem cell transplantation

Interventions

Mesenchymal stem cell transplantationOTHER

Mesenchymal stem cell transplantation through percutaneous injection.

Mesenchymal stem cell transplantation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Closed spinal cord injury at thoracic or thoracolumbar level bellow T8, or open spinal cord injury, at the same level, provided that the mechanism of the lesion is a spinal shock, ischemia or hematoma
  • ASIA class A
  • Signing the written consent

You may not qualify if:

  • Anatomical transection of the spinal cord
  • Spinal cord lesion by sharp objects
  • Ongoing infections
  • Terminal, neurodegenerative or primary hematological diseases
  • Osteopathies which determine a higher risc to the bone marrow puncture
  • Coagulopathies
  • Severe hepatic, renal or heart failure
  • Pregnancy or lactation
  • Clinical conditions that hinder the percutaneous injection of the cells such as arthrodesis
  • Use of metallic implants near vascular structures (such as cardiac pacemaker or aortic prosthesis) which won't allow patients to perform MRI
  • Participation in other clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Mesenchymal Stem Cell Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Ricardo R dos Santos, MD, PhD

    Hospital São Rafael

    PRINCIPAL INVESTIGATOR

  • Milena BP Soares, PhD

    Hospital São Rafael

    STUDY DIRECTOR

  • Bruno SF Souza, MD, Msc

    Hospital São Rafael

    STUDY CHAIR

  • Ticiana F Larocca, MD, Msc

    Hospital São Rafael

    STUDY CHAIR

  • Rodrigo L Alves, MD, PhD

    Hospital São Rafael

    STUDY CHAIR

  • Yuri MA Souza, MD

    Hospital São Rafael

    STUDY CHAIR

  • André C Matos, MD

    Hospital São Rafael

    STUDY CHAIR

  • Cristiane F Villarreal, PhD

    Hospital São Rafael

    STUDY CHAIR

  • Alexandre S Carvalho-da-Silva, Student

    Hospital São Rafael

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Tomography-guided mesenchymal stem cells injection.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 20, 2014

First Posted

June 2, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

BR(1)