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

NCT ID: NCT01325103

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Spinal Cord Injury

Keywords

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Spinal cord injury Mesenchymal stem cells Bone marrow

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Mesenchymal stem cell transplantation.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stem Cell Transplantation

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

Group Type EXPERIMENTAL

Stem Cell Transplantation

Intervention Type PROCEDURE

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

Interventions

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Stem Cell Transplantation

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

Intervention Type PROCEDURE

Other Intervention Names

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BMMSC - Bone Marrow Mesenchymal Stem Cells.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oswaldo Cruz Foundation

OTHER

Sponsor Role collaborator

Irep Sociedade de Ensino Superior Médio e Fundamental Limitada

OTHER

Sponsor Role collaborator

Hospital Espanhol

NETWORK

Sponsor Role collaborator

Hospital Sao Rafael

OTHER

Sponsor Role lead

Responsible Party

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Ricardo Ribeiro dos Santos

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ricardo R. dos Santos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Sao Rafael

Milena Botelho P. Soares, PhD

Role: STUDY_DIRECTOR

Hospital Sao Rafael

Marcus Vinícius P. Mendonça, MD

Role: STUDY_CHAIR

Hospital Sao Rafael

Cláudia B. Pinheiro, PhD

Role: STUDY_CHAIR

Hospital Sao Rafael

Ticiana X. Ferreira, MD

Role: STUDY_CHAIR

Hospital Sao Rafael

Cristiane F. Villarreal, PhD

Role: STUDY_CHAIR

Hospital Sao Rafael

Luiz Flávio M. Silva, MD

Role: STUDY_CHAIR

Hospital Sao Rafael

Marco A. Almeida, MD

Role: STUDY_CHAIR

Hospital Sao Rafael

Ubirajara B. Júnior, MD, PhD

Role: STUDY_CHAIR

Hospital Sao Rafael

Locations

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Hospital São Rafael

Salvador, Estado de Bahia, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 25406723 (View on PubMed)

Other Identifiers

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SCI-001

Identifier Type: -

Identifier Source: org_study_id