A Phase 2 interventional study of Autologous mesenchymal cells transplantation in Spinal Cord Injury, sponsored by Hospital Sao Rafael. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-11-28.
Sponsored by Hospital Sao Rafael · Phase 2, Interventional, and Treatment
The purpose of this study is to analyze the safety and efficacy of autologous bone marrow mesenchymal stem cell transplantation in patients with thoracolumbar chronic and complete spinal cord injury.
This is a randomized, non-placebo controlled, prospective, phase II clinical trial. The study population will consist of 40 patients who had spinal cord injury for at least 12 months, with thoracolumbar 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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 40 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Hospital Sao Rafael is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Twenty subjects will be randomly assigned to receive two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.
Biological: Autologous mesenchymal cells transplantation
Twenty subjects will be randomly assigned to be clinically followed, without any specific intervention.
Two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.
Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging spinal cord injury
Time frame: 12 months
Functional improvement in ASIA (American Spinal Injury Association) grade
The investigators will evaluate the conversion rate from ASIA A to B or C in 12 months.
Time frame: 12 months
Functional improvement regarding the AIS (ASIA Impairment Scale) scores (light touch, pin prik and motor force)
AIS (ASIA Improvement Scale) degree on the ASIA score will be assessed in order to evaluate sensitivity and motor force in 12 months.
Time frame: 12 months
Improvements in sensorial mapping and neuropathic pain
The patients will be submitted to specific questionnaires and clinical examinations in order to evaluate improvements in sensorial mapping and neuropathic pain.
Time frame: 12 months
No study locations are listed for this record.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Sao Rafael