Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete 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: NCT02574572 |
Recruitment Status : Unknown
Verified November 2017 by Ricardo Ribeiro dos Santos, Hospital Sao Rafael.
Recruitment status was: Recruiting
First Posted : October 14, 2015
Last Update Posted : November 28, 2017
|
Tracking Information | ||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | April 10, 2015 | |||||||||||||||||||||||||||||||||||||||
First Posted Date ICMJE | October 14, 2015 | |||||||||||||||||||||||||||||||||||||||
Last Update Posted Date | November 28, 2017 | |||||||||||||||||||||||||||||||||||||||
Actual Study Start Date ICMJE | September 6, 2017 | |||||||||||||||||||||||||||||||||||||||
Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | |||||||||||||||||||||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging [ Time Frame: 12 months ] | |||||||||||||||||||||||||||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||||||||||||||||||||||||||
Change History | ||||||||||||||||||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
|
|||||||||||||||||||||||||||||||||||||||
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 Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury | |||||||||||||||||||||||||||||||||||||||
Official Title ICMJE | Evaluation of the Safety and Potential Effectiveness of Autologous Mesenchymal Stem Cells Transplantation in Subjects With Cervical Chronic and Complete Spinal Cord Injury | |||||||||||||||||||||||||||||||||||||||
Brief Summary | The purpose of this study is to analyze the safety and efficacy of autologous bone marrow mesenchymal stem cell transplantation in patients with cervical chronic and complete spinal cord injury. | |||||||||||||||||||||||||||||||||||||||
Detailed Description | This is a pilot, phase I study, in a prospective cohort. The study population will consist of 10 patients who had spinal cord injury for at least 12 months, with cervical chronic and complete spinal cord injury, ASIA grade A. A practitioner, a surgeon and a nurse will review the medical records of the patients to determine the presence / absence of inclusion / exclusion criteria. If the patient is a potential candidate for the study, an interview will be scheduled to review and confirm his/her eligibility. Patients will undergo a series of clinical and neurological assessments and will also be submitted to the following procedures:
Also as part of the preoperative evaluation, the patients will respond to questions from the SF (Short Form) -36 questionnaire (for assessment of quality of life) and the questionnaires for the assessment of neuropathic pain. Clinical follow-up will be kept for patients who suspend their participation in the study for any adverse event and / or laboratory abnormality, or for the patient's own desire, following insurance protocols. In addition to the clinical and surgical follow-up, specific medical care will be offered to patients who experience adverse events, until stabilization of the patient, even if the target date for completion of the study has been exceeded. The candidates included in the study will be asked to voluntarily participate and give their informed written consent. |
|||||||||||||||||||||||||||||||||||||||
Study Type ICMJE | Interventional | |||||||||||||||||||||||||||||||||||||||
Study Phase ICMJE | Phase 1 | |||||||||||||||||||||||||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||||||||||||||||||||||||||||||||||||||
Condition ICMJE | Spinal Cord Injury | |||||||||||||||||||||||||||||||||||||||
Intervention ICMJE | Biological: Autologous mesenchymal cells transplantation
All patients will undergo laminectomy and autologous mesenchymal cells injection into the lesion area.
|
|||||||||||||||||||||||||||||||||||||||
Study Arms ICMJE | Experimental: Single group
Patients with spinal cord injury that will undergo laminectomy and autologous mesenchymal cells intralesional injection
Intervention: Biological: Autologous mesenchymal cells transplantation
|
|||||||||||||||||||||||||||||||||||||||
Publications * | Not Provided | |||||||||||||||||||||||||||||||||||||||
* 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 | Unknown status | |||||||||||||||||||||||||||||||||||||||
Estimated Enrollment ICMJE |
10 | |||||||||||||||||||||||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | |||||||||||||||||||||||||||||||||||||||
Estimated Study Completion Date ICMJE | June 30, 2020 | |||||||||||||||||||||||||||||||||||||||
Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | |||||||||||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||||||||||||||||||||||||||||||||
Sex/Gender ICMJE |
|
|||||||||||||||||||||||||||||||||||||||
Ages ICMJE | 18 Years to 65 Years (Adult, Older 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 | NCT02574572 | |||||||||||||||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | SCI-003 | |||||||||||||||||||||||||||||||||||||||
Has Data Monitoring Committee | Yes | |||||||||||||||||||||||||||||||||||||||
U.S. FDA-regulated Product |
|
|||||||||||||||||||||||||||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||||||||||||||||||||
Current Responsible Party | Ricardo Ribeiro dos Santos, Hospital Sao Rafael | |||||||||||||||||||||||||||||||||||||||
Original Responsible Party | Same as current | |||||||||||||||||||||||||||||||||||||||
Current Study Sponsor ICMJE | Hospital Sao Rafael | |||||||||||||||||||||||||||||||||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||||||||||||||||||||||||||||||||
Collaborators ICMJE | Not Provided | |||||||||||||||||||||||||||||||||||||||
Investigators ICMJE |
|
|||||||||||||||||||||||||||||||||||||||
PRS Account | Hospital Sao Rafael | |||||||||||||||||||||||||||||||||||||||
Verification Date | November 2017 | |||||||||||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |