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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325103
• Other study ID #: SCI-001
• Status: Completed
• Phase: N/A
• First received: March 28, 2011
• Last updated: November 27, 2017
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: Hospital Sao Rafael
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Procedure:
• Stem Cell Transplantation
All patients will undergo autologous bone marrow stem cell transplantation into the lesion area.

Locations

Country	Name	City	State
Brazil	Hospital São Rafael	Salvador	Bahia

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Sao Rafael	Hospital Espanhol, Irep Sociedade de Ensino Superior Médio e Fundamental Limitada, Oswaldo Cruz Foundation

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and safety of bone marrow stem cell transplantation in patients with spinal cord injury		Six months
Secondary	Functional improvement in muscle strength	Functional improvement in muscle strength assessed by the Frankel scale.	Six months
Secondary	Improvement of sphincters control.	Improvement of sphincters control (anal and bladder).	Six months

External Links

•   Website by Center of Biotechnology and Cell Therapy - Brazil.