Autologous Bone Marrow Stem Cell Transplantation in Patients With Subacute Spinal Cord Injury

NCT ID: NCT05671796

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-12-01

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).

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mesenchymal stem cell transplantation

Intervention Type: GENETIC

Patients will undergo two autologous bone marrow stem cell transplantation into the lesion area

Placebo

Two subcutaneous injections of 1 ml each, containing glycophysiological solution.with a 90-day interval between applications.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Patients will undergo two subcutaneous injections of 1 ml of glycophysiological solution into the lesion area by sham procedure

Interventions

Mesenchymal stem cell transplantation

Patients will undergo two autologous bone marrow stem cell transplantation into the lesion area

Intervention Type: GENETIC

Placebo

Patients will undergo two subcutaneous injections of 1 ml of glycophysiological solution into the lesion area by sham procedure

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oswaldo Cruz Foundation

OTHER

Sponsor Role: collaborator

Federal University of Bahia

OTHER

Sponsor Role: collaborator

Hospital Geral do Estado

UNKNOWN

Sponsor Role: collaborator

Hospital da Bahia

UNKNOWN

Sponsor Role: collaborator

SENAI CIMATEC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Milena Soares, PhD

Role: STUDY_DIRECTOR

SENAI CIMATEC

Augusto Mota, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital da Bahia

Locations

Senai Cimatec

Salvador, Estado de Bahia, Brazil

Countries

Brazil

Central Contacts

Carolina Macedo, PhD

Role: CONTACT

carolthemacedo@gmail.com

557138795574

Lila Araujo, PhD

Role: CONTACT

lila.araujo@fieb.org.br

557138795574

Other Identifiers

PLC01/2021

Identifier Type: -

Identifier Source: org_study_id