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

November 27, 2017 updated by: Ricardo Ribeiro dos Santos, Hospital Sao Rafael

Phase 1 Study of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 41256900
        • Hospital Sao Rafael

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stem Cell Transplantation
Patients with spinal cord injury that will undergo autologous bone marrow stem cell transplantation.
Procedure: Stem Cell Transplantation
All patients will undergo autologous bone marrow stem cell transplantation into the lesion area.
Other Names:
  • BMMSC - Bone Marrow Mesenchymal Stem Cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility and safety of bone marrow stem cell transplantation in patients with spinal cord injury
Time Frame: Six months
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional improvement in muscle strength
Time Frame: Six months
Functional improvement in muscle strength assessed by the Frankel scale.
Six months
Improvement of sphincters control.
Time Frame: Six months
Improvement of sphincters control (anal and bladder).
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sao Rafael

Collaborators

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

Investigators

  • Principal Investigator: Ricardo R. dos Santos, MD, PhD, Hospital Sao Rafael
  • Study Director: Milena Botelho P. Soares, PhD, Hospital Sao Rafael
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (ESTIMATE)

March 29, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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