NCT01325103

Brief Summary

This research investigates the use of autologous bone marrow stem cells in patients with spinal cord injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

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

Study Start

First participant enrolled

July 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 28, 2017

Status Verified

May 1, 2014

Enrollment Period

2.4 years

First QC Date

March 28, 2011

Last Update Submit

November 27, 2017

Conditions

Spinal Cord Injury

Keywords

Spinal cord injuryMesenchymal stem cellsBone marrow

Outcome Measures

Primary Outcomes (1)

  • Feasibility and safety of bone marrow stem cell transplantation in patients with spinal cord injury

    Six months

Secondary Outcomes (2)

  • Functional improvement in muscle strength

    Six months

  • Improvement of sphincters control.

    Six months

Study Arms (1)

Stem Cell Transplantation

EXPERIMENTAL

Patients with spinal cord injury that will undergo autologous bone marrow stem cell transplantation.

Procedure: Stem Cell Transplantation

Interventions

Stem Cell TransplantationPROCEDURE

All patients will undergo autologous bone marrow stem cell transplantation into the lesion area.

Also known as: BMMSC - Bone Marrow Mesenchymal Stem Cells.
Stem Cell Transplantation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 50 years old
  • Traumatic spinal cord injury at the thoracic or lumbar level
  • Classification Frankel A
  • Indication for spinal surgery for traumatic lesions of bone

You may not qualify if:

  • Section of the spinal anatomy
  • Open injuries
  • Active infectious diseases
  • Terminal patients
  • Neurodegenerative diseases
  • Primary hematologic diseases
  • Bone reflecting increased risk for spinal puncture
  • Coagulopathies
  • Hepatic dysfunction
  • Pregnancy
  • Other medical complications that contraindicate surgery, including major respiratory complications
  • Participation in another clinical trial
  • Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital São Rafael

Salvador, Estado de Bahia, 41256900, Brazil

Location

Related Publications (1)

  • Mendonca MV, Larocca TF, de Freitas Souza BS, Villarreal CF, Silva LF, Matos AC, Novaes MA, Bahia CM, de Oliveira Melo Martinez AC, Kaneto CM, Furtado SB, Sampaio GP, Soares MB, dos Santos RR. Safety and neurological assessments after autologous transplantation of bone marrow mesenchymal stem cells in subjects with chronic spinal cord injury. Stem Cell Res Ther. 2014 Nov 17;5(6):126. doi: 10.1186/scrt516.

    PMID: 25406723DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ricardo R. dos Santos, MD, PhD

    Hospital Sao Rafael

    PRINCIPAL INVESTIGATOR

  • Milena Botelho P. Soares, PhD

    Hospital Sao Rafael

    STUDY DIRECTOR

  • Marcus Vinícius P. Mendonça, MD

    Hospital Sao Rafael

    STUDY CHAIR

  • Cláudia B. Pinheiro, PhD

    Hospital Sao Rafael

    STUDY CHAIR

  • Ticiana X. Ferreira, MD

    Hospital Sao Rafael

    STUDY CHAIR

  • Cristiane F. Villarreal, PhD

    Hospital Sao Rafael

    STUDY CHAIR

  • Luiz Flávio M. Silva, MD

    Hospital Sao Rafael

    STUDY CHAIR

  • Marco A. Almeida, MD

    Hospital Sao Rafael

    STUDY CHAIR

  • Ubirajara B. Júnior, MD, PhD

    Hospital Sao Rafael

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Mesenchymal stem cell transplantation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phase 1 Study of Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 29, 2011

Study Start

July 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 28, 2017

Record last verified: 2014-05

Locations

BR(1)