Phase 2, Double- Blind, Placebo- Controlled , Randomized Clinical Trial of Autologous Bone Marrow Stem Cell Transplantation in Patients With Subacute Spinal Cord Injury
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- SENAI CIMATEC
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change from Baseline ASIA scale and 12 Months after autologous mesenchymal stem cells transplantation in individuals with subacute spinal cord injury
Study Overview
Brief Summary
The aim of this study is to evaluate the efficacy and safety of intrathecal administration of autologous mesenchymal stem cells in participants with subacute spinal cord injury.
Detailed Description
Spinal cord injury (SCI) constitutes a social and economic problem with the aggravating factor of being able to limit individual capacity, leading to a condition of unproductiveness and incapacity. At present, there is no effective treatment for recovering an injured spinal cord. Our research group was one of the pioneers in the study of mesenchymal stem cell therapies in the treatment of SCI, having carried out preclinical studies, as well as clinical studies with participants with complete spinal cord injuries, which demonstrated that stem cell transplantation mesenchymal (MSC) from autologous bone marrow was a safe and effective therapy in these studies. This project proposes the investigation of this therapy in participants with complete spinal cord injuries in the thoracolumbar region, in the subacute phase (defined between 3 to 6 months after the event), aiming to evaluate the safety and efficacy of the injection of mesenchymal stem cells. For this, we propose a double-blind, randomized clinical study to demonstrate the efficacy and safety of bone marrow MSC transplantation in participants with complete paraplegia, classified by ASIA Impairment Scale (AIS) grade A, by TRM, with subacute lesion. Forty participants will be referred by reference institutions and then recruited to be subsequently subjected to randomization, if eligible, with a group of 20 participants treated by intrathecal infusion of autologous MSCs, and another of 20 participants allocated to the control group, using a glucophysiological solution as a subcutaneous placebo. Each participant, after recruitment, will be monitored for a period of approximately 01 (one) year. The preparation of the CTMs will be done in accordance with the standards of good manufacturing practices. Both groups participating in the study will be submitted to pre- and post-treatment evaluations. The effectiveness of the therapy will be evaluated using the scale established by ASIA (American Spinal Injury Association) and the International Classification of Functioning, Disability and Health (ICF).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Both sexes over 18 years old;
- •Closed or open spinal cord injury at the thoracic or lumbar level in the subacute phase (between 3 and 6 months after the event);
- •ASIA A rating.
Exclusion Criteria
- •Section of the spinal anatomy;
- •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 magnetic resonance
Arms & Interventions
Mesenchymal stem cell transplantation
Two intrathecal autologous bone marrow stem cell transplantation of 1 ml solution containing 5x10,000,000 MSCs each with a 90-day interval between applications.
Intervention: Mesenchymal stem cell transplantation (Genetic)
Placebo
Two subcutaneous injections of 1 ml each, containing glycophysiological solution.with a 90-day interval between applications.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Change from Baseline ASIA scale and 12 Months after autologous mesenchymal stem cells transplantation in individuals with subacute spinal cord injury
Time Frame: Baseline and 12 months
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), commonly referred to as the ASIA Exam, was developed by the American Spinal Injury Association (ASIA) as a universal classification tool for spinal cord injuries based on a standardized sensory and motor assessment.It involves both a Motor and Sensory examination to determine the Sensory Level and Motor Level for each side of the body (Right and Left), the single Neurological Level of Injury (NLI) and whether the injury is Complete or Incomplete. Elements of the scale include: Grade A: The impairment is complete, Grade B ,C and D: The impairment is incomplete with some differences between them.;Grade E: The patient's functions are normal
Secondary Outcomes
- Assessment of neuropathic pain by McGill Pain Questionnaire(Baseline, 1 month, 6 months and 12 months)
- Improvement in quality of life, measured by the WhoQof-bref Questionnaire.(Baseline, 1 month, 6 months and 12 months)
- Change from Baseline AIS scale and 12 Months after autologous mesenchymal stem cells transplantation(Baseline and 12 months)
- Assessment sensory impairment after subacute spinal cord injury with Quantitative Sensory Test(Baseline, 1 month, 6 months and 12 months)
- Assessment sensory impairment after subacute spinal cord injury with von Frey filaments(Baseline, 1 month, 6 months and 12 months)