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

NCT05671796 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-01-12

No results posted yet for this study

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

Interventions

GENETIC

Mesenchymal stem cell transplantation

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • Federal University of Bahia

    collaborator OTHER

  • Hospital Geral do Estado

    collaborator UNKNOWN

  • Hospital da Bahia

    collaborator UNKNOWN

  • SENAI CIMATEC

    lead OTHER

Principal Investigators

  • Milena Soares, PhD · SENAI CIMATEC

  • Augusto Mota, PhD · Hospital da Bahia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-09-25
Completion
2023-12-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05671796 on ClinicalTrials.gov