Clinical trial NCT05671796: Autologous Bone Marrow Stem Cell Transplantation in Patients With Subacute Spinal Cord Injury
Official title: Phase 2, Double- Blind, Placebo- Controlled , Randomized Clinical Trial of Autologous Bone Marrow Stem Cell Transplantation in Patients With Subacute Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Spinal Cord Injuries
Keywords: Spinal cord injury
Mesenchymal stem cells
Bone marrow
Lead sponsor: SENAI CIMATEC
Sponsor class: OTHER
Collaborators: name: Oswaldo Cruz Foundation
name: Federal University of Bahia
name: Hospital Geral do Estado
name: Hospital da Bahia
First posted: 2023-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline ASIA scale and 12 Months after autologous mesenchymal stem cells transplantation in individuals with subacute spinal cord injury
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change from Baseline AIS scale and 12 Months after autologous mesenchymal stem cells transplantation
timeFrame: Baseline and 12 months
measure: Improvement in quality of life, measured by the WhoQof-bref Questionnaire.
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Assessment of neuropathic pain by McGill Pain Questionnaire
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Assessment sensory impairment after subacute spinal cord injury with von Frey filaments
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Assessment sensory impairment after subacute spinal cord injury with Quantitative Sensory Test
timeFrame: Baseline, 1 month, 6 months and 12 months
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Senai Cimatec
state: Bahia
Study officials:
affiliation: SENAI CIMATEC
name: Milena Soares, PhD
role: STUDY_DIRECTOR
affiliation: Hospital da Bahia
name: Augusto Mota, PhD
role: PRINCIPAL_INVESTIGATOR
References: