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

This study has been completed.
Sponsor:
Collaborators:
Oswaldo Cruz Foundation
Irep Sociedade de Ensino Superior Médio e Fundamental Limitada
Hospital Espanhol
Information provided by (Responsible Party):
Ricardo Ribeiro dos Santos, Hospital Sao Rafael
ClinicalTrials.gov Identifier:
NCT01325103
First received: March 28, 2011
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Spinal Cord Injury
Procedure: Stem Cell Transplantation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Hospital Sao Rafael:

Primary Outcome Measures:
  • Feasibility and safety of bone marrow stem cell transplantation in patients with spinal cord injury [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Functional improvement in muscle strength [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Functional improvement in muscle strength assessed by the Frankel scale.

  • Improvement of sphincters control. [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Improvement of sphincters control (anal and bladder).


Enrollment: 20
Study Start Date: July 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: BMMSC - Bone Marrow Mesenchymal Stem Cells.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325103

Locations
Brazil
Hospital São Rafael
Salvador, Bahia, Brazil, 41256900
Sponsors and Collaborators
Hospital Sao Rafael
Oswaldo Cruz Foundation
Irep Sociedade de Ensino Superior Médio e Fundamental Limitada
Hospital Espanhol
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
  More Information

Additional Information:
No publications provided

Responsible Party: Ricardo Ribeiro dos Santos, Phase 1 Study of Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury, Hospital Sao Rafael
ClinicalTrials.gov Identifier: NCT01325103     History of Changes
Other Study ID Numbers: SCI-001
Study First Received: March 28, 2011
Last Updated: May 27, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Sao Rafael:
Spinal cord injury
Mesenchymal stem cells
Bone marrow

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 24, 2014