Back to results

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

Primary Purpose

Spinal Cord Injury

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Stem Cell Transplantation

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal cord injury, Mesenchymal stem cells, Bone marrow

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital São Rafael

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell Transplantation

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional improvement in muscle strength

Functional improvement in muscle strength assessed by the Frankel scale.

Improvement of sphincters control.

Improvement of sphincters control (anal and bladder).

Full Information

NCT ID

NCT01325103

First Posted

March 28, 2011

Last Updated

November 27, 2017

Sponsor

Hospital Sao Rafael

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01325103

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Sao Rafael

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury

Keywords

Spinal cord injury, Mesenchymal stem cells, Bone marrow

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Mesenchymal stem cell transplantation.

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stem Cell Transplantation

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Stem Cell Transplantation

Other Intervention Name(s)

BMMSC - Bone Marrow Mesenchymal Stem Cells.

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Six months

Secondary Outcome Measure Information:

Title

Functional improvement in muscle strength

Description

Functional improvement in muscle strength assessed by the Frankel scale.

Time Frame

Six months

Title

Improvement of sphincters control.

Description

Improvement of sphincters control (anal and bladder).

Time Frame

Six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: