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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01325103

Enrollment

Registered

2011-03-29

Start date

2010-07-31

Completion date

2012-12-31

Last updated

2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury, Mesenchymal stem cells, Bone marrow

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.

Interventions

PROCEDUREStem Cell Transplantation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Mesenchymal stem cell transplantation.

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
Feasibility and safety of bone marrow stem cell transplantation in patients with spinal cord injury	Six months

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026