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

NCT05671796 | Unknown Phase 2 DMC

• 1 other identifier: PLC01/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injury; Mesenchymal stem cells; Bone marrow

Outcome Measures

Primary Outcomes (1)

• Change from Baseline ASIA scale and 12 Months after autologous mesenchymal stem cells transplantation in individuals with subacute spinal cord injury

  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

  Baseline and 12 months

Secondary Outcomes (5)

• Change from Baseline AIS scale and 12 Months after autologous mesenchymal stem cells transplantation

  Baseline and 12 months

• Improvement in quality of life, measured by the WhoQof-bref Questionnaire.

  Baseline, 1 month, 6 months and 12 months

• Assessment of neuropathic pain by McGill Pain Questionnaire

  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

• Assessment sensory impairment after subacute spinal cord injury with Quantitative Sensory Test

  Baseline, 1 month, 6 months and 12 months

Study Arms (2)

Mesenchymal stem cell transplantation

EXPERIMENTAL

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.

Genetic: Mesenchymal stem cell transplantation

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Mesenchymal stem cell transplantation GENETIC

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

Mesenchymal stem cell transplantation

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SENAI CIMATEC: lead
• Oswaldo Cruz Foundation: collaborator
• Federal University of Bahia: collaborator
• Hospital Geral do Estado: collaborator
• Hospital da Bahia: collaborator

Study Sites (1)

Senai Cimatec

Salvador, Estado de Bahia, 41650-010, Brazil

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Mesenchymal Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Milena Soares, PhD

  SENAI CIMATEC

  STUDY DIRECTOR

• Augusto Mota, PhD

  Hospital da Bahia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Macedo, PhD

CONTACT

557138795574; carolthemacedo@gmail.com

Lila Araujo, PhD

CONTACT

557138795574; lila.araujo@fieb.org.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 5, 2023
• Study Start: April 1, 2023
• Primary Completion: September 25, 2023
• Study Completion: December 1, 2023
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)