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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04493918

Enrollment

Registered

2020-07-30

Start date

2017-05-21

Completion date

2020-12-30

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mesenchymal Stem Cell, Spinal Tuberculosis

Keywords

Mycobacterium tuberculosis

Brief 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.

Interventions

COMBINATION_PRODUCTMesenchymal 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_PRODUCTNaCl 0.9%

Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

Participants do not know which treatment they receives. Outcome assessor is a radiologist

Eligibility

Sex/Gender

ALL

Age

15 Years to 64 Years

Healthy volunteers

Inclusion criteria

* Clinicoradiologically diagnoses Spinal Tuberculosis * receives Anti TB drugs * minimun destruction 1/3 vertebral body

Exclusion criteria

* patient under 15 years old * reject to be included in the study

Design outcomes

Primary

Measure	Time frame	Description
Vertebral bony fusion	1 Year	trabecular bone on xray and CT scan

Countries

Indonesia

Contacts

Primary ContactAhmad Jabir Rahyussalim, PhD

rahyussalim71@ui.ac.id+62811819466

Backup ContactTri Kurniawati, Mrs

trie3k@ui.ac.id+628121134311

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026