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

Study Overview
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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.

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

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Procedure: Stem Cell Transplantation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Mesenchymal stem cell transplantation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cell Transplantation<br>Patients with spinal cord injury that will undergo autologous bone marrow stem cell transplantation. | Procedure: Stem Cell Transplantation<br>* All patients will undergo autologous bone marrow stem cell transplantation into the lesion area.<br>* Other names: BMMSC - Bone Marrow Mesenchymal Stem Cells.;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injury, Mesenchymal stem cells, Bone marrow