Skip to main content
OpenTrials
Completed

NCT Number: NCT01325103

Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital São Rafael

Salvador, Estado de Bahia, 41256900, Brazil

About this study

The aim of this study is to evaluate autologous bone marrow stem cells transplantation as a safe and potentially beneficial treatment for patients with spinal cord injury.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

stem cell transplantation

Procedure

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

Other names: BMMSC - Bone Marrow Mesenchymal Stem Cells.

Primary outcomes

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

    Time frame: Six months

Secondary outcomes

  1. Functional improvement in muscle strength

    Time frame: Six months

    Functional improvement in muscle strength assessed by the Frankel scale.

  2. Improvement of sphincters control.

    Time frame: Six months

    Improvement of sphincters control (anal and bladder).

Sponsors and collaborators

Lead sponsor

Hospital Sao Rafael

Other

Collaborators

  • Hospital Espanhol
  • Irep Sociedade de Ensino Superior Médio e Fundamental Limitada
  • Oswaldo Cruz Foundation

Registry information

Official study title

Phase 1 Study of Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2011
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.