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Trial record 1 of 37 for:    stem cell Spinal Cord Injury AND autologous
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Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01325103
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : November 28, 2017
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

Tracking Information
First Submitted Date  ICMJE March 28, 2011
First Posted Date  ICMJE March 29, 2011
Last Update Posted Date November 28, 2017
Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2011)
Feasibility and safety of bone marrow stem cell transplantation in patients with spinal cord injury [ Time Frame: Six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01325103 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2011)
  • Functional improvement in muscle strength [ Time Frame: Six months ]
    Functional improvement in muscle strength assessed by the Frankel scale.
  • Improvement of sphincters control. [ Time Frame: Six months ]
    Improvement of sphincters control (anal and bladder).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury
Official Title  ICMJE Phase 1 Study of Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Mesenchymal stem cell transplantation.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Stem Cell Transplantation
Patients with spinal cord injury that will undergo autologous bone marrow stem cell transplantation.
Intervention: Procedure: Stem Cell Transplantation
Publications * Mendonça 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2017)
14
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2011)
20
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01325103
Other Study ID Numbers  ICMJE SCI-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ricardo Ribeiro dos Santos, Hospital Sao Rafael
Study Sponsor  ICMJE Hospital Sao Rafael
Collaborators  ICMJE
  • Oswaldo Cruz Foundation
  • Irep Sociedade de Ensino Superior Médio e Fundamental Limitada
  • Hospital Espanhol
Investigators  ICMJE
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
PRS Account Hospital Sao Rafael
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP