Clinical trial NCT01325103: Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury
Official title: Phase 1 Study of Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Spinal cord injury
Mesenchymal stem cells
Bone marrow
Lead sponsor: Hospital Sao Rafael
Sponsor class: OTHER
Collaborators: name: Oswaldo Cruz Foundation
name: Irep Sociedade de Ensino Superior Médio e Fundamental Limitada
name: Hospital Espanhol
First posted: 2011-03-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mesenchymal stem cell transplantation.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Feasibility and safety of bone marrow stem cell transplantation in patients with spinal cord injury
timeFrame: Six months
Secondary outcomes:
measure: Functional improvement in muscle strength
timeFrame: Six months
measure: Improvement of sphincters control.
timeFrame: Six months
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital São Rafael
state: Bahia
Study officials:
affiliation: Hospital Sao Rafael
name: Ricardo R. dos Santos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Sao Rafael
name: Milena Botelho P. Soares, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Sao Rafael
name: Marcus Vinícius P. Mendonça, MD
role: STUDY_CHAIR
affiliation: Hospital Sao Rafael
name: Cláudia B. Pinheiro, PhD
role: STUDY_CHAIR
affiliation: Hospital Sao Rafael
name: Ticiana X. Ferreira, MD
role: STUDY_CHAIR
affiliation: Hospital Sao Rafael
name: Cristiane F. Villarreal, PhD
role: STUDY_CHAIR
affiliation: Hospital Sao Rafael
name: Luiz Flávio M. Silva, MD
role: STUDY_CHAIR
affiliation: Hospital Sao Rafael
name: Marco A. Almeida, MD
role: STUDY_CHAIR
affiliation: Hospital Sao Rafael
name: Ubirajara B. Júnior, MD, PhD
role: STUDY_CHAIR
References:
citation: Mendonca 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.