Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury
This study is ongoing, but not recruiting participants.
Sponsor:
Hospital Sao Rafael
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: October 21, 2011
Last verified: October 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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).
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 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
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: | October 21, 2011 |
| 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 Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013