NCT04493918

Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection

Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ahmad Jabir Rahyussalim · Academic / Other
• Sex: All
• Age: 15 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effectiveness of locally implantation of mesenchymal stem cell on vertebral bone defects due to infection of mycobacterium tuberculosis. there are controlled participants who receives placebo and patients who receives implantation of MSc

Detailed description

Mesenchymal Stem Cell are implanted in Spinal Tuberculosis patient. MSC has inflammatory effect and the ability to form into new bone. In Spinal Tuberculosis, the spread of bacteria is commonly hematogenous, where the focus of infection is at the anterior part of the vertebrae near the subchondral bone. The infection process continues, where the necrotic casseous fragments formed into local abcess that may spread to the sorrounding area. Patient with spinal tuberculosis who receives Anti TB Drug, is planned to undergo debridement, spinal stabilization. After thorough debridement, patient who fall into control group receives normal saline injection, patients who fall into treatment group will receive Mesenchymal Stem Cell.

Conditions

• Spinal Tuberculosis
• Mesenchymal Stem Cell

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Mesenchymal Stem cell + Nacl 0.9%	Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml + MSC 30 million unit
COMBINATION_PRODUCT	NaCl 0.9%	Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml

Timeline

• Start date: 2017-05-21
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2020-07-30
• Last updated: 2020-08-03

Locations

1 site across 1 country: Indonesia